JP2007115289A - Data verification support method and data verification support system - Google Patents

Abstract

An object of the present invention is to support data verification work after drug sales using a data verification support server connected to an implementer terminal and a verifier terminal via a network.
An object of the present invention is to provide a data verification support method for supporting a data verification operation after drug sales using a data verification support server connected to a performer terminal and a verifier terminal via a network. When the patient information is input to the survey form input screen for each medicine requested for the survey, the verifier terminal displays the logical check result, and the verifier terminal displays the survey form registration information and the logical check result registered by the data verification support server. Is displayed and the re-survey request information or the survey completion is supplied to the verification support server, and the data verification support server supplies the re-survey form information of the drug requested for re-survey to the implementer terminal and manages the version number of the re-request This is achieved by supplying a progress state of data verification to the implementer terminal or the verifier terminal.
[Selection] Figure 2

Description

  The present invention uses one or more practitioner terminals, one or more verifier terminals, and a data verification support server connected to the practitioner terminals and the verifier terminals via a network. It relates to supporting data verification work.

  Traditionally, pharmaceutical companies have been conducting post-marketing surveys on drugs that are on the market to ensure the safety and effectiveness of the drugs. In post-marketing surveillance, a pharmaceutical manufacturer visits a doctor to request a drug survey / test, and hands over a prescribed survey form to the doctor. After filling out the form and signing or stamping it, it is provided to the pharmaceutical manufacturer via the person in charge of collection. In other words, the post-marketing survey process usually involves transferring the condition of the patient who prescribed the drug requested by the pharmaceutical manufacturer from the medical record to the questionnaire, and the pharmaceutical manufacturer transfers the questionnaire to the DB (Data Base). input. A pharmaceutical manufacturer reports to the Ministry of Health and Welfare by collecting and analyzing data input to the DB.

  At a later date, in order to ensure that the reported information is based on a survey form from a doctor, the survey form that is filled in and signed or stamped by the doctor is stored and managed.

  Through the above steps, the effectiveness and safety of the drug are confirmed.

  However, the conventional post-marketing survey process has the following problems.

  In order to accurately report to the Ministry of Health and Welfare, for example, when a pharmaceutical manufacturer person in charge enters data into a DB with a survey form given by a doctor, the data on the same survey form must be separated by multiple personnel. When the input data and the input data are different from each other, they are corrected and reconfirmed to prevent mistakes caused by data input and to improve the accuracy of data input. Usually, it is obliged to investigate more than a predetermined number of cases, for example, more than 3,000 cases, for one pharmaceutical product, so it is confirmed that the data entered from more than 3,000 cases is consistent. This verification requires a lot of effort. However, it has been difficult to achieve the same accuracy as the input data by the doctor himself.

  Furthermore, in the transfer from the medical chart to the survey form performed by the doctor, it is required that the patient can be identified for privacy protection of personal information, but in order to protect the personal information, it is required that the patient's name is not described in the survey form. Yes. Therefore, write your name with initials. After a match of data input to the DB is confirmed by a plurality of personnel, a logical contradiction is verified using a program or the like that verifies whether the data has a logical contradiction. When there is a logical contradiction in the survey form, the pharmaceutical manufacturer person in charge writes a comment to the doctor on the request form, and visits the doctor again to request a review. The same process as described above is repeated for the survey form obtained from the doctor by the re-survey. Such re-investigation is repeated many times until there is no logical contradiction in the survey form data. When the reliability of the survey form data is confirmed through repeated re-investigations, the data is fixed and data analysis is possible for reporting to the Ministry of Health and Welfare.

  In the above-described conventional post-marketing process, the labor and time required by doctors and pharmaceutical manufacturers until the reliability of the data on the questionnaire is confirmed is considerable. Also, in the survey form, the name that identifies the patient is initially posted on the survey form by the doctor, so if the doctor receives a re-survey, the doctor will indicate what chart the requested re-survey form was It was a time-consuming task for doctors because they had to find them. In other investigation processes conducted at pharmaceutical manufacturers, there were similar problems in the post-marketing investigation process.

  Therefore, an object of the present invention is to support verification of data input to each item of a survey form for examining the influence of product implementation.

  In order to solve the above problems, the present invention includes one or more implementer terminals, one or more verifier terminals, a data verification support server connected to the implementer terminals and the verifier terminals via a network, A data verification support method for supporting post-pharmaceutical data verification work using the data verification support server, wherein the data verification support server registers and manages a contract facility for each pharmaceutical product to be surveyed and a survey performer, and a contract facility DB , A case management information DB for managing survey information on patients registered by the practitioner, a survey form information DB for managing survey form information in which information on a patient after a pharmaceutical prescription entered in the practitioner is input, A re-survey request information DB for managing a re-survey request to the survey form, and supplying the survey form information relating to the pharmaceutical product requested to be surveyed from the verification support server to the implementer terminal The step of displaying the survey form input screen corresponding to the survey form information for each medicine requested for the investigation, and the implementer terminal prescribing the requested medicine When patient information is input, a step of further displaying a logic check result, a step of supplying survey form registration information registered on the survey form screen from the performer terminal to the data verification support server, and the data The verification support server registers and manages the supplied survey form registration information in the survey form information DB, and registers the survey form related to the requested medicine from the verification support server to the verifier terminal. Supplying information, the verifier terminal displaying the survey form registration information, further displaying a logic check result, and the verifier terminal to the verification support server Supplying re-survey request information or survey completion for the survey form registration information; and when the data verification support server determines that the re-survey request request information exists in the implementer terminal, a re-survey request Supplying the re-survey form information related to the pharmaceutical product to be managed and managing the version number of the re-request, and the data verification support server performs each of the steps for the survey form information and the re-survey form information. A state in which the survey form information is supplied to the implementer terminal, a state in which the survey form registration information is supplied from the implementer terminal, a state in which the survey form registration information is supplied to the verifier terminal, the verifier A state in which re-survey request information is supplied from a terminal; a state in which the re-survey form information is supplied to the performer terminal; a state in which the re-survey form registration information is supplied from the performer terminal; A status flag indicating whether at least four of the states supplied with survey completion are registered in the status flag, and supplying a progress status of data verification to the implementer terminal or the verifier terminal; The information is configured to include at least arrangement information in the input field, prescription drug information, patient background information, treatment progress, and examination values.

  In such a data verification support method, a re-investigation can be requested to the practitioner repeatedly while a re-investigation is required for the questionnaire sent by the practitioner. Stored with numbers.

  Therefore, the verifier does not need to visit the implementer repeatedly to conduct a re-survey until the questionnaire is completed, and does not need to input the questionnaire data by multiple people, Since the completed implementation slip is stored together with the version number, version number management can be performed automatically. Furthermore, since the administrator of the data verification support server can be made independent of the implementer and the verifier, the reliability of the information on the survey form can be guaranteed.

  The data verification support server is, for example, a server managed by an ASP service provider.

  The practitioner is, for example, a doctor.

  The verifier is, for example, a pharmaceutical manufacturer person in charge.

  The survey form is a survey form in which, for example, the condition of the patient after the medicine is administered to the patient by a doctor is entered, and the influence of side effects and the like due to the medicine is investigated.

  Further, the reliability of the survey form information collected from the practitioner can be secured by an independent administrator of the data verification support server.

  According to the present invention, while the survey form sent by the implementer needs to be re-surveyed, the implementer can be requested to conduct a re-survey, and the completed survey form is stored together with the version number. Therefore, the verifier does not need to visit the implementer repeatedly to acquire the questionnaire until the questionnaire is completed, and does not need to input the questionnaire data by multiple verifiers. In addition, since the completed implementation slip is stored together with the version number, the version number can be automatically managed. Furthermore, since the administrator of the data verification support server can be made independent of the implementer and the verifier, the reliability of the information on the survey form can be guaranteed. In addition, since the data verification support server can be configured to perform authentication confirmation based on the authentication information attached to the survey form, even if a data verification support server is installed on the verifier side, It is possible to guarantee the reliability of the information on the vote.

  Further, according to the present invention, the information management server converts the personal information into the initial when the personal name is input on the terminal side that is input as personal information. Also, when managing personal information, it is managed with the encrypted personal name and the converted personal name. Furthermore, it can be controlled to provide personal information with the personal name to the first user who has entered the personal information, and to provide personal information with the initial to the second user who receives the provision of personal information. .

  Hereinafter, embodiments of the present invention will be described with reference to the drawings.

  A network in which a survey form management system to which a data reliability verification method according to an embodiment of the present invention is applied is, for example, as shown in FIG.

  As shown in FIG. 1, the survey form management system 100 includes a contract facility information DB (database) 111 that manages contract information concluded between a pharmaceutical manufacturer and a doctor, and a case management that manages information related to a patient registered by a doctor in charge. Information DB 112, survey form information DB 113 for managing a survey form in which the condition of a patient after prescribing a pharmaceutical requested by a pharmaceutical manufacturer from a doctor terminal 30 by a doctor in charge for each case (for each patient), and a doctor terminal 30 And a re-survey request information DB 114 for managing a re-survey request for a survey form submitted by the pharmaceutical manufacturer terminal 40 and the doctor terminal 30 and the Internet 50.

  When a pharmaceutical manufacturer person in charge uses the survey form management system 100 from the pharmaceutical manufacturer terminal 40, the doctor in charge of the facility, such as a hospital contracted with the survey form management system 100 via the Internet 50, and the facility that requested the investigation. Enter information about. The input information is stored in the contract facility information DB 111.

  When a pharmaceutical manufacturer person in charge makes a request for inputting a survey form from a pharmaceutical manufacturer terminal 40 to a predetermined doctor in charge via the survey form management system 100, a survey request e-mail for requesting a survey to the doctor in charge is transmitted. Hereinafter, the e-mail is assumed to be e-mail.

  The doctor in charge inputs patient information from a patient information input screen for inputting information related to the patient provided by the survey form management system 100 based on the patient's medical record after receiving the survey request mail at the doctor terminal 30. The input information about the patient is stored in the case management information DB 112 as case information. Thereafter, the doctor terminal 30 can input the survey form information input screen for inputting the survey for each case provided by the survey form management system 100. Data input to the input screen from the doctor terminal 30 is stored in the survey form information DB 113.

  Accordingly, the patient input screen and the survey form information that the survey form management system 100 provides the doctor terminal 30 with the work that the doctor in charge has conventionally transferred the case data from the medical record to the survey form (paper) and the writing work to the survey form. When the doctor in charge directly inputs data from the input screen, the person in charge of the pharmaceutical manufacturer does not need to visit the doctor in charge to collect the questionnaire, and the doctor in charge can directly enter the questionnaire from the doctor terminal 30. It becomes possible to eliminate the need for data entry confirmation work by several pharmaceutical manufacturer personnel. Therefore, it is possible to reduce labor and increase the accuracy of information. That is, the pharmaceutical manufacturer can acquire the data itself input by the doctor in charge without using a human operation.

  The contents of the survey form data stored in the survey form information DB 113 are verified by the logical check of the survey form management system 100, and based on the verification result, the pharmaceutical manufacturer person in charge is in charge of a re-survey request from the pharmaceutical manufacturer terminal 40 This is done by e-mail requesting a re-survey to the doctor.

  By repeating the logic check and the re-survey request by the survey form management system 100 several times, the survey form completed by correcting the logical contradiction etc. is managed in the survey information DB 113 as fixed data that cannot be changed.

  Next, an operation procedure performed at the pharmaceutical manufacturer terminal 40 and the doctor terminal 30 when the survey form management system 100 is used in the network configuration shown in FIG. 1 will be described with reference to FIG.

  FIG. 2 is a diagram showing an operation procedure when the survey form management system is used.

  In FIG. 2, the person in charge of the pharmaceutical manufacturer inputs the contract facility and the doctor in charge information from the pharmaceutical manufacturer terminal 40 (operation procedure 21), and requests the doctor in charge to input the survey form (operation procedure 22). According to the operation procedure 22, the survey form management system 100 enables the survey form input from the doctor in charge and transmits a predetermined mail requesting the survey form from the pharmaceutical manufacturer terminal 40.

  In addition, the pharmaceutical manufacturer person in charge, if there is no input to the questionnaire from the doctor in charge after a while after the operation procedure 22, a predetermined mail for prompting the survey form input provided by the questionnaire management system 100 Can be transmitted to the doctor in charge (operation procedure 23).

  The doctor in charge uses the doctor terminal 30 to input a case from the patient input screen provided by the survey form management system 100 after the survey form input request in the operation procedure 22 or 23 (operation procedure 24). The doctor in charge inputs a case with reference to the patient's chart. In this survey form management system 100, the doctor in charge can input the patient name described in the medical chart in katakana. The initial conversion program transmitted from the survey form management system 100 to the doctor terminal 30 converts the patient name to the initial. When a case inputted by the doctor in charge from the doctor terminal 30 is registered in the case management information DB 112, the inputted name of the katakana is encrypted, and the initial of the patient name and the encrypted patient name are stored together with the case.

  Therefore, thereafter, when providing the survey form information, the survey form management system 100 displays the patient name in the katakana notation for the doctor terminal 30 and the initial notation for the pharmaceutical manufacturer terminal 40. It becomes possible.

  Therefore, since the doctor in charge can refer to the patient's name by the full name at the doctor terminal 30 at the time of the re-investigation, the doctor can easily refer to the chart. In addition, the doctor in charge and the person in charge of the pharmaceutical manufacturer can specify the patient by the initials when making a contact such as confirming the survey form.

  Further, in the operation procedure 24, the survey form management system 100 confirms by searching the case management information DB 112 whether there is the same case information, and when there is the same case information, the same case is sent to the doctor terminal 30. In order to notify that the information has already been registered, the doctor in charge can prevent registration of inappropriate duplicate cases.

  When the registration of the case is completed, that is, when the input of the patient information is completed by the doctor in charge, the survey form management system 100 manages the information on the survey form according to the case with the survey form management information, and the doctor side of the survey form “Not sent” is set as the status, and “(blank)” is set as the status of the pharmaceutical manufacturer (see FIG. 3).

  The doctor in charge inputs and updates the information from the survey form input screen provided by the survey form management system 100 for each case after inputting the case information from the doctor terminal 30, and transmits the survey form to the person in charge of the pharmaceutical manufacturer. (Operation procedure 25). In the operation procedure 25, the survey form management system 100 constructs a survey form input screen based on the survey form input screen while referring to the item definition of the survey form information DB 113, and provides the survey form input screen to the doctor terminal 30. To do. Further, information on the survey form input from the doctor terminal 30 by the doctor in charge is stored in the survey form information DB 113 as survey form information. Furthermore, an email notifying that a predetermined survey form has been input is transmitted from the doctor in charge to the pharmaceutical manufacturer person in charge by an operation of mail transmission at the doctor terminal 30. Then, the survey form management system 100 changes the doctor-side status of the survey form in the survey form management information to “transmitted” and the pharmaceutical manufacturer-side status to “new arrival” (see FIG. 3).

  Furthermore, in the operation procedure 25, information indicating the occurrence of an emergency event that requires urgent action, such as an adverse event or a pregnancy case, with respect to the requested medicine based on the information on the survey form input from the doctor terminal 30 Is included, the survey form management system 100 generates an email indicating the occurrence of an emergency event and transmits it to the pharmaceutical manufacturer person in charge (for example, a safety person in charge).

  By sending an email indicating the occurrence of an emergency event or the like automatically performed by the survey form management system 100, the doctor in charge can save the trouble of notifying the person in charge of the pharmaceutical manufacturer of the case where the emergency event has occurred individually. In addition, since the pharmaceutical manufacturer person in charge can receive the mail at the pharmaceutical manufacturer terminal 40 when the doctor in charge inputs the survey form, it is possible to promptly respond to a report indicating the occurrence of an emergency event.

  After the pharmaceutical manufacturer person in charge makes an input request or a prompt to the doctor in charge from the pharmaceutical manufacturer terminal 40 according to the operation procedure 22 or 23, the investigation form management system 100 provides based on the survey form management information. Referring to the contract facility information screen, the survey form whose status is displayed as “New Arrival” is selected, and the information on the survey form is confirmed (operation procedure 26). The survey form management system 100 changes the survey form status on the doctor side to “manufacturer receipt” and the survey form status on the pharmaceutical manufacturer side to “under confirmation” (see FIG. 3).

  In the operation procedure 26, when the pharmaceutical manufacturer terminal 40 selects the survey form, the survey form management system 100 executes a logical check for verifying whether or not there is a logical contradiction in the information on the selected survey form, and displays the execution result. The survey form including this is displayed on the pharmaceutical manufacturer terminal 40. The pharmaceutical manufacturer person in charge sets items that need to be re-investigated by the doctor in charge based on the survey form including the displayed logical check execution result. The information regarding the execution result of the logical check by the survey form management system 100 and the item that requires the re-survey set by the pharmaceutical manufacturer terminal 40 is stored in the re-survey request information DB 114 as the re-survey information. In addition, among the set items, when a request content is input by a pharmaceutical manufacturer person in charge, the request content is stored in the resurvey request information DB 114 as a resurvey request content.

  On the other hand, when a request for re-survey to the doctor in charge is not required, the survey form is completed (operation procedure 31).

  The person in charge of the pharmaceutical manufacturer makes a request for re-survey to the doctor in charge (operation procedure 27). The survey form management system 100 transmits a mail requesting a predetermined re-survey from the pharmaceutical manufacturer person in charge to each doctor in charge by the operation procedure 27 on the pharmaceutical manufacturer terminal 40. The survey form management system 100 changes the survey form status on the doctor side in the survey form management information to “new arrival” and the survey form status on the pharmaceutical manufacturer side to “in request” (see FIG. 3). In addition, the survey form management system 100 transfers the survey version information to the survey form history table 134 by incrementing the history version number as the survey form history.

  After the re-investigation request, the pharmaceutical manufacturer person in charge refers to the contract facility information screen, and when the survey form status remains “Requesting”, the doctor in charge asks the doctor in charge for the re-investigation (operation procedure 28). The survey form management system 100 transmits a mail prompting a predetermined re-survey from the pharmaceutical manufacturer terminal 40 to the doctor in charge by the operation procedure 28 by the pharmaceutical manufacturer staff.

  After the doctor in charge receives an email requesting a re-investigation from a pharmaceutical manufacturer person in charge or an email prompting a re-survey at the doctor terminal 30, the information on the survey form subject to the re-survey is corrected (operation procedure 28). . The survey form management system 100 changes the survey form status on the doctor side to “unsent” and the survey form status on the pharmaceutical manufacturer side remains “in request” (see FIG. 3).

  The doctor in charge transmits the corrected survey form information from the doctor terminal 30 to the person in charge of the pharmaceutical manufacturer (operation procedure 29). The survey form management system 100 sends an email indicating that a predetermined re-survey has been performed to the pharmaceutical manufacturer staff in accordance with the operation procedure 29 by the doctor in charge.

  When the pharmaceutical manufacturer person in charge receives an email indicating that a predetermined re-survey has been performed at the pharmaceutical manufacturer terminal 40 from the doctor in charge, the contract facility information screen provided by the survey form management system 100 based on the survey form management information , The survey form whose status is displayed as “New Arrival” is selected, and the information of the survey form is confirmed (operation procedure 31). The survey form management system 100 changes the survey form status on the doctor side to “manufacturer receipt” and the survey form status on the pharmaceutical manufacturer side to “under confirmation” (see FIG. 3).

  In the operation procedure 31, when the pharmaceutical manufacturer person in charge selects the survey form, the survey form management system 100 verifies whether there is a logical contradiction in the information of the selected survey form as in the operation procedure 26. The check is executed, and the survey form information including the execution result is displayed on the pharmaceutical manufacturer terminal 40. The pharmaceutical manufacturer person in charge sets items that require re-survey by the doctor in charge based on the survey form including the execution result of the displayed logical check, and requests the doctor in charge again in operation procedure 27 To do.

  When it is not necessary to request a re-survey to the doctor in charge, the survey form is completed (operation procedure 31).

  In the operation procedure 31, the pharmaceutical manufacturer person in charge confirms the survey form information at the pharmaceutical manufacturer terminal 40, and if it is not necessary to request a re-investigation to the doctor in charge, the survey form is entered by inputting the completion date of the survey form. Is completed (operation procedure 31). By this operation procedure 31 in the pharmaceutical manufacturer terminal 40, the survey form management system 100 keeps the survey form status on the doctor side as “manufacturer received” and changes the survey form status on the pharmaceutical manufacturer side to “completed” (FIG. 3). reference).

  The pharmaceutical manufacturer person in charge outputs the completed survey form from the pharmaceutical manufacturer terminal 40 (operation procedure 32). Therefore, in addition to the computerized survey form by the survey form management system, the pharmaceutical manufacturer person in charge can visit the doctor in charge and manage the survey form (paper) stamped by the doctor in charge.

  FIG. 3 is a diagram illustrating an example of the transition of the survey form status.

  In FIG. 3, when patient information is input at the doctor terminal 30 in the operation procedure 24 according to FIG. 2, “not sent” is set for the doctor status, and “(blank)” is set for the pharmaceutical manufacturer status. Is set. In this status, the doctor in charge can input, save, and refer to information on the survey form screen provided by the survey form management system 100 at the doctor terminal 30. On the other hand, in this status, since the doctor in charge does not transmit the survey form to the person in charge of the pharmaceutical manufacturer, it is impossible for the pharmaceutical manufacturer person in charge to refer to the survey form.

  When the survey form is transmitted by the doctor in charge in the operation procedure 25, the doctor's status is changed to “sent”, and the status of the pharmaceutical manufacturer is set to “new arrival”. In this status, the doctor in charge can only refer to the survey form information, and information input, update, and deletion to the survey form are prohibited. On the other hand, the person in charge of the pharmaceutical manufacturer can only refer to the survey form information, and can input, save, refer to, and update the re-survey request information. In this status, if the pharmaceutical manufacturer person in charge determines that the survey form has been entered, the survey form completion date can be entered, saved, and referenced. In addition, when the doctor stops the survey, when the doctor in charge cannot continue to input the survey form, or when the survey cannot be conducted for a long time due to a business trip, etc. It is possible to input, save, and refer to the reason for non-collection.

  When the survey form information is confirmed on the pharmaceutical manufacturer terminal 40 by the pharmaceutical manufacturer in operation procedure 26, the status of the doctor is changed to “manufacturer received” and the status of the pharmaceutical manufacturer is changed to “under confirmation”. Is done. In this status, the doctor in charge can only refer to the survey form information at the doctor terminal 30 as in the previous operation procedure 25, and information input, update, and deletion to the survey form are prohibited. On the other hand, in the same manner as the previous operation procedure 25, the pharmaceutical manufacturer person in charge can only refer to the survey form information and can input, save, refer to, and update the re-survey request information. It becomes possible. In this status, if the pharmaceutical manufacturer person in charge determines that the survey form has been entered, the survey form completion date can be entered, saved, and referenced. In addition, when the doctor stops the survey, when the doctor in charge cannot continue to input the survey form, or when the survey cannot be conducted for a long time due to a business trip, etc. It is possible to input, save, and refer to the reason for non-collection.

  When the pharmaceutical manufacturer requests re-investigation at the pharmaceutical manufacturer terminal 40 in the operation procedure 27, the status of the doctor is changed to “New Arrival”, and the status of the pharmaceutical manufacturer is changed to “Requesting”. In this status, the doctor in charge can refer to and update the survey form information at the doctor terminal 30 and can only refer to the re-survey request item. On the other hand, the pharmaceutical manufacturer person in charge can only refer to the survey form information and the re-survey request information at the pharmaceutical manufacturer terminal 40. Also, in this status, the pharmaceutical manufacturer person in charge is unable to conduct a long-term investigation due to a business trip, etc. In this case, it is possible to input, save, and refer to the date when the survey form cannot be collected and the reason why it cannot be collected.

  In operation procedure 28, when the doctor in charge corrects the survey form information requested to be re-investigated by the doctor terminal 30, the status of the doctor is changed to “unsent” and the status of the pharmaceutical manufacturer is “requesting”. It remains unchanged. In this status, the doctor in charge can refer to and update the survey form information and can refer to the re-survey request items at the doctor terminal 30 as in the previous operation procedure 27. On the other hand, the person in charge of the pharmaceutical manufacturer can only refer to the survey form information and the re-survey request information at the pharmaceutical manufacturer terminal 40 as in the operation procedure 27. Also, in this status, the pharmaceutical manufacturer person in charge is unable to conduct a long-term investigation due to a business trip, etc. In this case, it is possible to input, save, and refer to the date when the survey form cannot be collected and the reason why it cannot be collected.

  When the doctor transmits survey form information at the doctor terminal 30 in the operation procedure 29, the status of the doctor is changed to “sent” and the status of the pharmaceutical manufacturer is changed to “new arrival”. In this status, the doctor in charge can only refer to the survey form information and the re-survey request information at the doctor terminal 30 as in the pre-operation procedure 28. On the other hand, the pharmaceutical manufacturer person in charge can refer to the survey form information and the previous re-survey request information on the pharmaceutical manufacturer terminal 40. In addition, it is possible to input, save, refer to, and update the re-survey request items for the survey form information received this time. Further, in this status, if the pharmaceutical manufacturer person in charge determines that the survey form has been input, the date of completion of the survey form can be entered, saved, and referenced. In addition, when the doctor stops the survey, when the doctor in charge cannot continue to input the survey form, or when the survey cannot be conducted for a long time due to a business trip, etc. It is possible to input, save, and refer to the reason for non-collection.

  When the pharmaceutical manufacturer person in charge confirms the survey form information in the operation procedure 30, the status of the doctor is changed to “manufacturer received” and the status of the pharmaceutical manufacturer is changed to “under confirmation”. In this status, the doctor in charge can only refer to the survey form information and the re-survey request information at the doctor terminal 30 as in the previous operation procedure 29. On the other hand, the person in charge of the pharmaceutical manufacturer can refer to the survey form information and the previous re-survey request information at the pharmaceutical manufacturer terminal 40 as in the previous operation procedure 29. In addition, it is possible to input, save, refer to, and update the re-survey request items for the survey form information received this time.

  In the operation procedure 31, when the pharmaceutical manufacturer person in charge enters the survey completion date on the survey form at the pharmaceutical manufacturer terminal 40, the status of the doctor is set to “manufacturer received” and the status of the pharmaceutical manufacturer is set to “completed”. Be changed. In this status, both the doctor in charge and the person in charge of the pharmaceutical manufacturer can only refer to the survey form information.

  An operation procedure 90 not shown in FIG. 2 indicates a state transition when an input of a survey form uncollectible date and a reason for non-collection is performed at the pharmaceutical manufacturer terminal 40 during the operation procedures 25 to 30. In this case, the status of the doctor is changed to “manufacturer receipt”, and the status of the pharmaceutical manufacturer is changed to “impossible”. In this status, both the doctor in charge and the person in charge of the pharmaceutical manufacturer can only refer to the survey form information.

  Since the status of the pharmaceutical manufacturer is displayed in response to the survey form according to the operation procedure, the pharmaceutical manufacturer person in charge at the pharmaceutical manufacturer terminal 40 has a plurality of doctors for the same or different protocols (meaning each survey). Even when re-investigating several times between the survey forms, it is possible to easily manage the survey form with the same operation procedure.

  Similarly, since the doctor's status is displayed corresponding to the survey form in accordance with the operation procedure, the doctor in charge conducts surveys at a plurality of hospitals or other facilities where the doctor in charge works for the same or different protocols. In this case, and when conducting surveys from a plurality of pharmaceutical manufacturer personnel, it is possible to easily manage survey forms with the same operation procedure.

  The hardware configuration of the survey form management system corresponding to the data reliability verification apparatus according to the embodiment of the present invention is, for example, as shown in FIG.

  4, this system has a CPU (Central Processing Unit) 11, a memory unit 12, an output unit 13, an input unit 14, a display unit 15, an auxiliary storage device 16, a CD-ROM drive unit 17, and a communication unit 18. ing. Each of these units 11, 12, 13, 14, 15, 16, 17 and the communication unit 18 are connected to the bus B.

  The CPU 11 controls the survey form management system according to the program stored in the memory unit 12 and performs processing in the survey form management system as described later. The memory unit 12 includes a RAM and a ROM, and stores programs executed by the CPU 11, data necessary for processing by the CPU 11, data obtained by processing by the CPU 11, and the like. A part of the memory unit 12 is allocated as a work area used for processing by the CPU 11.

  The output unit 13 includes a printer or the like and outputs a processing result or designated information. The input unit 14 includes a mouse, a keyboard, and the like, and is used by the administrator of the survey form management system to input various information necessary for performing a survey form management process as will be described later. The display unit 15 displays various information necessary for the administrator under the control of the CPU 11.

  The auxiliary storage device 16 is composed of, for example, a hard disk unit, and stores various files and programs.

  A program related to the survey form management process is provided to the system by the CD-ROM 20, for example. That is, when the CD-ROM 20 storing the program related to the survey form management process is set in the CD-ROM drive unit 17, the CD-ROM drive unit 17 reads the program from the CD-ROM 20, and the read program is It is installed in the auxiliary storage device 16 via the bus B. When the survey form management process is activated, the CPU 11 starts the process according to the program installed in the auxiliary storage device 16. The medium for storing the program is not limited to the CD-ROM 20 and may be any computer-readable medium.

  Next, a functional configuration of the survey form management system for realizing the processing according to the operation procedure will be described with reference to FIG.

  FIG. 5 is a diagram illustrating an example of a functional configuration of the survey form management system.

  From FIG. 5, the survey form management system 100 mainly responds to processing requests according to the above-described operation procedure from the database management unit 200 that stores and manages various databases in the auxiliary storage device 16 of FIG. 4 and the doctor terminal 30. 4. Control the doctor side processing unit 300 that executes the process in response, the pharmaceutical manufacturer side processing unit 400 that executes the process in response to the processing request from the pharmaceutical manufacturer terminal 40 according to the operation procedure, and the communication unit of FIG. The communication processing unit 48 for performing data communication via the Internet 50, the input / output processing unit 44 for controlling the data input processing from the input unit 14 and the data output processing to the output unit 13 in FIG. 4, and the display in FIG. The display control unit 45 controls the data display processing to the unit 15.

  The database management unit 200 includes a contract facility information DB 111 that manages information on the contract facility and the doctor in charge input by the operation procedure 21 in FIG. 2, a case management information DB 112 that manages case information input by the operation procedure 24, Based on the protocol, the survey form information DB 113 for managing information on the survey form in which the information of the patient for whom the medicine is prescribed for each case by the operation procedure 25 is input, and the information on the re-survey request input by the operation procedure 27 are displayed. And a re-survey request information DB 114 to be managed.

  Further, the contract facility information DB 111 includes a facility information table 121 indicating information on a hospital where the doctor in charge works, and a doctor information table 122 indicating information on the doctor in charge.

  The survey form information DB 113 also includes a survey form management information table 131 for managing the survey form management information for each case based on the protocol and a survey form input screen for managing the survey form input screen information indicating the configuration of the survey form input screen. An information table 132, a survey form information table 133 for managing the survey form information input in the survey form, a survey form history table 134 for copying and managing the survey form information completed by the operation procedure 31, and a survey form input screen The information has an item definition table 135 for managing item definitions for configuring the screen.

  The re-survey request information DB 114 includes a re-survey information table 141 that manages re-survey information indicating a re-survey request, and a re-survey request content table 142 that manages re-survey request content.

  The doctor-side processing unit 300 stores an initial conversion program 302 for converting a patient name into an initial by the operation procedure 24, an identical case check unit 303 for checking whether the same case has already been registered, and patient information. A case management information processing unit 301 having a patient information storage processing unit 304, a survey form information input / update unit 305 for managing survey form information input by the operation procedure 25, and a survey that has been input by the operation procedure 25 The survey form sending unit 306 that sends a vote, the emergency event processing unit 307 that sends an email when there is information about an emergency event in the survey form entered in the operation procedure 25, and a request for a re-survey And a survey form information correction unit 308 for managing the survey form.

  The case management information processing unit 301 loads the initial conversion program 302 to the doctor terminal 30 and causes the doctor terminal 30 to operate. That is, the doctor in charge converts the patient name input at the doctor terminal 30 into initials. In addition, the case management information processing unit 301 controls the same case check unit 303 to prevent duplicate registration of the same case. Further, by controlling the patient information storage processing unit 304, the patient name is encrypted and the patient information is registered in the case management information DB 112.

  Further, the same case check unit 303 searches the case management information DB 112 with the patient's full name and the birthday of the patient, and checks whether the same patient information is registered.

  The survey form information input / update unit 305 configures a survey form screen by controlling the survey form input screen information table 132 and the item definition table 135 of the survey form information DB 113, and the communication processing unit 48 sends it to the doctor terminal 30. provide. In addition, the status of the doctor and the pharmaceutical manufacturer in the survey form management information table 131 is changed.

  When the doctor terminal 30 finishes inputting or updating the survey form in the operation procedure 25, the survey form transmission unit 306 updates the survey form information table 133. In addition, the status of the doctor and the pharmaceutical manufacturer in the survey form management information table 131 is changed.

  When the survey form information input / update unit 305 updates the survey form information table 133, the emergency event processing unit 307 checks whether information regarding a serious emergency event has been input to the survey form information. When information about emergency events is set, the information is notified by email to the pharmaceutical manufacturer.

  The survey form information correction unit 308 updates the survey form information table 133 in the survey form information DB 113 when the doctor in charge modifies the survey form at the doctor terminal 30 in response to the re-survey request in the operation procedure 28. . In addition, the status of the doctor and the pharmaceutical manufacturer in the survey form management information table 131 is changed.

  The pharmaceutical manufacturer side processing unit 400 includes a contract facility management unit 401, a survey form input request / promotion unit 402, a survey information confirmation unit 403, a logic check unit 404, a re-survey request / promotion unit 405, and a survey form completion. Unit 406 and survey form information output unit 407.

  In the operation procedure 21, the contract facility management unit 401 stores and manages information on the contract facility and the doctor in charge registered from the pharmaceutical manufacturer terminal 40 in the facility information table 121 and the doctor information table 122 of the contract facility information DB 111.

  The survey form input request / reminder unit 402 sends a mail indicating a predetermined survey form input request to the doctor in charge when the pharmaceutical manufacturer person in charge makes a request for inputting the survey form to the doctor in charge in the operation procedure 22. . In the operation procedure 23, when the pharmaceutical manufacturer person in charge urges the doctor in charge to input the survey form, an email indicating the urge to input the predetermined form is sent to the doctor in charge.

  In the operation procedure 26 or the operation procedure 30, when the pharmaceutical manufacturer person in charge selects the survey form at the pharmaceutical manufacturer terminal 40, the survey information confirmation unit 403 displays the survey form selected from the survey form information table 133 of the survey form information DB 113. Then, the logic check unit 404 is activated. The survey information confirmation unit 403 provides the pharmaceutical manufacturer terminal 40 with the extracted survey form and the execution result of the logic check executed by the logic check unit 404. In addition, the status of the doctor and the pharmaceutical manufacturer in the survey form management information table 131 is changed.

  The logic check unit 404 performs a logic check on the marked item that designates the logic check managed by the item definition table 135. For example, whether the information item indicating the date of the survey form extracted by the survey information confirmation unit 403, the information item that is a mandatory input is correctly input, and the input information item indicates the correct data range Perform a single item check to see if it exists. In addition, the logic check unit 404 executes a logic check that checks whether information items are logically correct.

  In the operation procedure 27, the re-investigation request / reminder 405 sends a mail indicating a predetermined re-survey request from the pharmaceutical manufacturer person in charge to the doctor in charge when the person in charge of the pharmaceutical manufacturer makes a re-survey request to the doctor in charge. The status of the doctor and the pharmaceutical manufacturer in the survey form management information table 131 is changed. Further, when the pharmaceutical manufacturer person in charge prompts the doctor in charge from the pharmaceutical manufacturer terminal 40 to send a re-investigation, an email indicating a predetermined re-survey is sent to the doctor in charge.

  When the survey form completion date is input by the pharmaceutical manufacturer person in charge at the pharmaceutical manufacturer terminal 40 in the operation procedure 31, the survey form completion unit 406 searches the survey form information DB 113 for the survey form in which the survey form completion date is input. It is extracted from the vote information table 133 and copied to the questionnaire information history table 134. Further, the completed survey form is stored as image data. The completed survey form cannot be modified thereafter.

  The image data is stored, for example, in a PDF (Portable Document File) format.

  Accordingly, authentication confirmation is performed based on the authentication information of the doctor in charge attached to the survey form. Therefore, even if the survey form management system 100 is installed on the pharmaceutical manufacturer side, it is possible to guarantee the reliability of the information on the survey form. Is possible.

  When the completed survey form is output by the pharmaceutical manufacturer person in charge in the operation procedure 32, the survey form information output unit 407 extracts the survey form to be output from the survey form information table 133 of the survey form information DB 113, Downloaded to the manufacturer terminal 40.

  The doctor side processing unit 300 is provided with a logic check unit 309 having the same function as the logic check unit 404 of the pharmaceutical manufacturer side processing unit 400, and is activated as appropriate from the survey form information input / update unit 305 and the survey form information correction unit 308. You may do it.

  Next, processing in the initial conversion program 302 will be described with reference to FIG.

  FIG. 6 is a flowchart for explaining the initial conversion process.

  From FIG. 6, the surname and first name of the patient input by the doctor in charge are acquired from the patient information input screen (step S51).

  It is determined whether the acquired name is a double-byte kana character (step S52). If the name is not a double-byte kana character, "?" Is returned (step S54), and the process proceeds to step S55. If the name is a double-byte kana character, the first character is converted into an initial by referring to the Roman character conversion table (step S53).

  The Romaji conversion table may be, for example, an alphabet corresponding to each Kana character.

  Subsequently, it is determined whether the acquired surname is a double-byte kana character (step S55). If the last name is not a double-byte kana character, "?" Is returned (step S57), and the process proceeds to step S58. If the surname is a double-byte kana character, the first character is converted into an initial by referring to the Romaji conversion table (step S56).

  It is determined whether the first and last names have been converted to initials (step S58). If the first and last names are not converted to initials, a message prompting the patient to re-enter the patient's name is displayed (step S61), and the process returns to step S51. If the first name and last name are converted to initials, the first name and last name are combined and set in the patient initial display area of the patient registration screen (step S59), and the initial conversion process ends.

  Processing in the same case check unit 303 of the doctor side processing unit 300 will be described with reference to FIG.

  FIG. 7 is a flowchart for explaining the same case check processing.

  From FIG. 7, the case management information record in the same facility is searched from the case management information DB 112 based on the date of birth and gender of the patient input on the patient information input screen by the doctor in charge (step S71).

  It is checked whether one or more identical cases have been detected (step S72). If no case is detected, the process proceeds to step S74. When one or more cases are detected, a list of the same cases is displayed on the patient information confirmation screen (step S73).

  It is determined whether to register the patient information input on the patient information input screen (step S74). For example, it is determined whether the “next” or “register” button is clicked by the doctor in charge. If not registered, the patient information input screen is displayed again (step S75), the patient information is prompted to be corrected, and the process returns to step S71. If it is registration, a registration process is executed (step S76), and the same case check process is terminated. The registration process is executed by the patient information storage processing unit 304 of the doctor side processing unit 300 in FIG.

  Details of the survey form management method will be described below with reference to the display screen.

  FIG. 8 is a diagram illustrating an example of a survey form management screen provided to a pharmaceutical manufacturer terminal.

  8, the survey form management screen 500 provided to the pharmaceutical manufacturer terminal 40 has a search condition input area 5001 for searching for a desired survey form, and a contract facility information input area for inputting and editing contract facility information. 5002 and a survey form list display area 5003 for displaying a list of survey forms based on the user ID of the person in charge of the pharmaceutical manufacturer.

  A search condition input area 5001 includes a search condition 502 for searching by selecting a protocol, a search condition 503 for searching for a facility that has not made a survey form input request to the doctor in charge, a search condition 504 for searching by date, It has a search condition 505 for searching with information about the MR in charge, a search condition 506 for searching with information about the doctor in charge, and a search button 507 for executing the search.

  When the pharmaceutical manufacturer person in charge inputs one or more of the search conditions 502 to 506 and clicks the search button 507, the search form list displayed in the search form list display area 50003 is displayed.

  The contract facility information input area 5002 includes a new contract facility input button 510 for newly inputting contract facility / doctor information, a contract facility information update button 511 for updating contract facility / doctor information, and a doctor in charge. An input request / prompt button 512 for making a survey form input request or prompting and a doctor changing button 513 for changing the doctor in charge of the input survey form.

  When a pharmaceutical manufacturer person in charge clicks any one of buttons 510 to 513, a corresponding screen is displayed (described later).

  The survey form list display area 5003 displays a survey form list based on the user ID input when the pharmaceutical manufacturer person in charge accesses the survey form management system. The survey form list displayed in the survey form list display area 5003 includes, for example, a check box for selecting a survey form, a request date and a request date indicating the date of requesting / promoting the survey form, as shown in a list 514, Name of facility and survey request facility number, MR in charge as business signature and collector, contract date for signing contract for pharmaceutical research, contract period indicating contract start date and end date, number of contracted contracts, name of doctor conducting survey (Scientific name) and items such as survey form status indicating the progress of the number of contracted cases are included. The survey form status is, for example, “acquisition”, “new arrival”, “confirming”, “requesting”, “completion / impossible”, etc. for each doctor in charge according to the status of the pharmaceutical manufacturer in FIG. The number of cases corresponding to the status item is displayed.

  The pharmaceutical manufacturer person in charge can click on the check box in the list 514 and click on the input request / prompt button 512 to make an input request or prompt to the doctor in charge.

  When the pharmaceutical manufacturer person in charge clicks on the new contract facility input button 510, a contract facility input screen 520 as shown in FIG. 9 is displayed.

  FIG. 9 is a diagram showing an example of a contract facility input screen for a pharmaceutical manufacturer person in charge to input contract facility information.

  9, the contract facility input screen 520 has an operation button area 5201 for operating to save input information, a facility information input area 5202 for inputting information on a new contract facility, and a doctor information input for inputting information on a doctor in charge. A region 5203.

  The operation button area 5201 includes a save button 521 for saving the input facility and doctor information, a delete button 522 for deleting the input facility and doctor information after saving, and a return to the previous screen (survey form management screen). And a return button.

  The facility information input area 5202 includes a survey request facility number assigned for each survey request, a contract date for signing a contract regarding a pharmaceutical research, a contract period indicating a contract start date and an end date, the number of contract cases, a hospital name, and the like. The name of the facility to be shown, the facility code for identifying the facility, the name of the business office to which the MR in charge as a convert belongs, the business office code for identifying the business office, the MR in charge showing the name of the MR in charge, and the MR employee in charge There are items such as an employee code and an e-mail indicating the e-mail address of the MR in charge.

  The doctor information input area 5203 includes items such as a deletion selected when deleting stored doctor information, a user ID for specifying a doctor, a doctor's name, a doctor's department name, and a department code for specifying a department name. In the deletion item, “New” is displayed when there is no saved doctor information, and a check box is displayed when there is saved doctor information. If there is stored doctor information to be deleted, it is selected by clicking a check box, and a delete button 522 is clicked. By this operation, the stored doctor information is deleted.

  For example, in the facility information input area 5202, the pharmaceutical manufacturer person in charge enters “20000101” on the contract date, “20001010 to 20011010” on the contract period, “150” on the contract case number, “Aiueo Hospital” on the facility name, Enter “East Japan Branch” in the field, “Ichiro Fujimi” in the MR in charge, “001” in the employee code, “tro@sei.fip” in the E-Mail, and “DOC1” as the user ID in the doctor information input area 5203. Enter “Shiro Ioyama” as the name, “Internal Medicine” as the department name, and “002” as the department code, and click the save button 521 (operation procedure 21). By this operation, the contract facility management unit 401 of the pharmaceutical manufacturer processing unit 400 in FIG. 5 is activated, and the input information in the facility information input area 5202 is associated with the protocol information 524 in the facility information table 121 of the contract facility information DB 11. While being stored, the input information of the doctor information input area 5203 is stored in the doctor information table 122.

  When the storage is completed, the message “save process completed successfully” is displayed in the message display area 525.

  When the return button 523 is clicked to return to the survey form management screen 500, the list 514 is updated with the input information stored on the contract facility input screen 520.

  In the survey form management screen 500 of FIG. 8, when the pharmaceutical manufacturer person in charge clicks the check box 515 to select, for example, “Aiueo Hospital” from the list 514, and clicks the input request / prompt button 512 (operation In step 22 or 23), a survey form input request screen as shown in FIG. 10 is displayed.

  FIG. 10 is a diagram illustrating an example of a survey form input request email.

  As shown in FIG. 10, the survey form input request screen 525 displays a selection information display area 526 for displaying the facility information selected by the person in charge of the pharmaceutical manufacturer, a selection area 527 for selecting a predetermined mail text, and the selected text. Text display button 528, a return button 529 for returning to the previous screen (survey form management screen), a send button 530 for sending mail, a doctor selection area 531 for selecting a doctor, and a destination for sending the same mail A selection area 532 for selecting the mail, and a mail area 533 for displaying the contents of the mail.

  When the pharmaceutical manufacturer person in charge selects, for example, “Survey Request Text” from the selection area 527, selects the doctor in charge “Shiro Itoyama” from the doctor selection area 531, and clicks the text display button 528, the mail area 533 is displayed. Based on a predetermined “survey request text”, the mail content in which the name of the doctor in charge is set is displayed.

  When the pharmaceutical manufacturer person in charge confirms the displayed mail contents and clicks the send button 530, the mail contents are transmitted to the doctor in charge (for example, Dr. Shiro Itoyama).

  When the survey form input request email is sent to the doctor in charge, “2000/01” is displayed in the upper part of the request date and the reminder date of the facility name “Aiueo Hospital” in the list 514 of the survey form management screen 500 shown in FIG. / 01 "is displayed. Similarly, when a pharmaceutical manufacturer person in charge sends an email indicating a prompt for a predetermined survey request to the doctor in charge, “Shiro Itoyama”, “2000/01/02” is displayed at the bottom of the request date and the prompt date items. Is displayed.

  Next, a survey form management method at the doctor terminal 30 by the doctor in charge who has received an email indicating a survey form input request will be described.

  FIG. 11 is a diagram illustrating an example of a protocol selection screen provided to the doctor terminal.

  A protocol selection screen 600 is displayed based on the user ID input when the doctor in charge connects to the survey form management system 100.

  As shown in FIG. 11, the protocol selection screen 600 displays a protocol list 601 indicating a list of protocols investigated by the doctor in charge.

  The protocol list 601 includes a protocol name and manufacturer name, a facility name and a department name, a contract period indicating a start date and an end date of a medicine based on a contract, the number of contract cases, and the number of input examples indicating the number of cases currently input. , New arrivals indicating the number of newly arrived questionnaires indicating that there is a request from the pharmaceutical manufacturer person in charge, unsent indicating the number of unsent questionnaires, sent indicating the number of submitted questionnaires, new cases It has items such as new registration for registration. The number of input examples, new arrivals, unsent, and sent items are displayed with underlined numbers. When the doctor in charge clicks on the number of the item to be referred to, a list regarding the item is displayed. When the number of input examples is clicked, a list of currently input cases is displayed. When a new item is clicked, a list of cases including a new survey form is displayed. When an unsent item is clicked, a list of cases including an unsent survey form is displayed. When the sent item is clicked, a list of cases in which all survey forms have been sent or received by the manufacturer is displayed.

  When a doctor in charge working at four facilities conducts a survey of pharmaceutical products from three pharmaceutical manufacturers, for example, as shown in the protocol list 601, the protocol name “Pharmaceutical ABC” and the manufacturer “Pharmaceutical manufacturer 1” are related. Protocol information 602, protocol information 603 relating to the protocol name “pharmaceutical LMN” and manufacturer “pharmaceutical manufacturer 6”, and protocol information 604 relating to the protocol name “pharmaceutical XYZ” and manufacturer “pharmaceutical manufacturer 8” include protocol information for each facility. Is displayed.

  Therefore, from the protocol information 602 in the protocol list 601, it is shown that the pharmaceutical ABC is investigated in the facilities “Aiueo Hospital”, “Tokyo Hospital”, “Yamanote Medical Clinic”, and “XX General Hospital”. , Indicates that research is being conducted at the facilities “Aiueo Hospital”, “Yamanote Clinic”, and “XX General Hospital”, and from the protocol information 604, indicates that research is being performed at the facilities “Tokyo Hospital” and “XX General Hospital” .

  The doctor in charge can easily check the progress of the survey request from each pharmaceutical manufacturer on a single screen by using this protocol list 601, and does not need to manage each pharmaceutical manufacturer.

  A screen for inputting patient information will be described with reference to FIGS.

  For example, in the protocol selection screen 600 of FIG. 11, the doctor in charge clicks new 605 when inputting patient information in response to a new survey request to the facility “Aiueo Hospital” that investigates the protocol name “Pharmaceutical ABC”. .

  By clicking the new 605 by the doctor in charge, a patient information input screen as shown in FIG. 12A is displayed. On the patient information input screen, the doctor in charge inputs patient information (case information) (operation procedure 24).

  From FIG. 12A, the patient information input screen 610 has a display area 611 for displaying the protocol information selected by the doctor in charge, a patient information input area 612 for inputting patient information, and the next for proceeding to the next screen. It has a button 613 and a return button 614 for returning to the previous screen.

  The patient information input area 612 includes an input area such as a patient name, sex, date of birth, and medical record number, and an initial display area displayed by clicking the initial conversion 6120.

  The doctor in charge inputs the patient name separately with the first name and the last name while referring to the medical record. For example, “Fuji” is input as the surname and “Taro” is input as the first name. Then, the initial conversion 6120 is clicked. By clicking on the initial conversion 6120, the initial conversion program 302 loaded on the doctor terminal 30 is activated, and the initial “TF” is displayed in the initial display area of the patient information input area 612 of the patient information input screen 610. Subsequently, the doctor in charge inputs sex, date of birth, and chart number. After the input to the patient information input area 612 is completed, the next button 613 is clicked to confirm the input patient information.

  When the doctor in charge clicks the next button 613, the same case check unit 303 of the doctor side processing unit 300 in FIG. 5 is activated and a patient information confirmation screen 615 as shown in FIG. 12B is displayed.

  From FIG. 12 (B), the patient information confirmation screen 615 includes a display area 616 for displaying the protocol information selected by the doctor in charge, a display area 617 for displaying the patient information input to the patient information input area 612 by the doctor in charge, A message display area 619 for displaying a message prompting the doctor to confirm patient information, the same case display area 620 showing the same case list as the execution result of the same case check unit 303, and a next button for proceeding to the next screen 621 and a return button 622 for returning to the previous screen.

  The display area 617 displays information input in the patient information input area 612 of the patient information input screen 610 and also displays a portrait 618 according to the patient's age and sex. The case management information processing unit 301 of the doctor side processing unit 300 in FIG. 5 calculates the age at the time of registration based on the date of birth of the patient, for example, based on a portrait table 625 as shown in FIG. , Display a portrait according to age and gender.

  When the doctor in charge confirms the input information on the patient information confirmation screen 615 based on the displayed portrait 618, the doctor in charge can determine whether the patient information is visually input correctly.

  When the doctor in charge clicks the next button 621, the patient information storage unit 304 of the doctor side processing unit 300 in FIG. 5 stores the input patient information in the case management information DB 112 as case information.

  On the other hand, when the doctor in charge clicks the return button 622, the inputted patient information is canceled. Therefore, it is possible to prevent patient information from being registered in duplicate.

  Next, the survey form information input screen for the doctor in charge to input information to the survey form in the operation procedure 25 of FIG. 2 will be described.

  FIG. 13 is a diagram showing a first example of the survey form information input screen.

  From FIG. 13, the survey form information input 630 as a first example is a display area 641 for displaying information on the protocol selected by the doctor on the protocol selection screen 600 of FIG. 11 and information input to the survey form. And a survey form input area 640.

  The display area 641 is displayed in the display area 631 including the protocol name and the facility name, the display area 632 displaying the case information, the display area 633 displaying the survey form name and the survey form status, and the survey form input area 640. A page selection area 634 for selecting a page of the survey form, a return button 636 for returning to the previous screen, and a help button 637 for displaying an explanation of an input method to the survey form input screen and the like.

  The display area 632 displays a case number, patient name initials, gender, date of birth, chart number, and the like.

  The display area 633 displays a survey form name, a state displayed according to the doctor's survey form status shown in FIG.

  The page selection area 634 includes a selection input area for selecting a page, and a display switching button 635 for displaying the selected page.

  When the doctor in charge selects, for example, “patient background” from the page selection area 634 and clicks the display switching button 635, the survey form information input / update unit 305 of the doctor side processing unit 300 in FIG. 5 is activated. The survey form information input / update unit 305 refers to the survey form input screen information table 132 and the item definition table 135 of the survey form information DB 113 on the basis of the selected page “patient background” to thereby display the “patient background” page. Is displayed in the survey form input area 640.

  Page “Patient Background” includes, for example, patient initials, gender, pregnancy information, date of birth, chart number, treatment category during study drug administration, body weight at the start of study drug administration, reason for use, onset factor, severity, complication Input area such as symptom, idiosyncratic constitution, past history, etc., and a save button 643 for saving input information.

  When the doctor in charge inputs information on the displayed page “patient background” and clicks the save button 643, the logic check unit 309 of the doctor-side processing unit 300 in FIG. 5 is activated, and the information input by the doctor in charge is logically displayed. It is checked whether or not there is a check, and the check result is displayed on a storage processing result screen 645 as shown in FIG.

  The doctor in charge can know that the weight input area 646 has not been entered, based on the check result displayed on the storage processing result screen 645. The doctor in charge clicks the close button 647 of the storage processing result screen 645 to close the storage processing result screen 645 and input the weight in the input area 646. The doctor in charge again clicks the save button 643 in the survey form input area 640, and when no error is detected by the logic check, information input to other pages is performed in the same manner.

  Another example of page selection will be described with reference to FIGS. 15A and 15B.

  As shown in FIG. 15A, the survey form for which the doctor in charge inputs information includes pages such as patient background, treatment course, clinical course, laboratory test value, adverse event 1, adverse event 2, and adverse event 3 comments.

  When the doctor in charge selects “treatment progress” from the page list displayed in the page selection 634 and clicks the display switching button 635, a survey as a second example is performed as shown in FIG. An input item of “treatment progress” is displayed in the survey form input area 640 of the form information input screen 630.

  When the doctor in charge selects “adverse event 2”, as shown in FIG. 16A, “adverse event 2” is input to the survey form input area 640 of the survey form information input screen 630 as the third example. The item is displayed.

  When the doctor in charge selects “comment about an adverse event”, an area where “comment about an adverse event” such as a side effect can be input is displayed in a survey form input area 640 as shown in FIG.

  Each time the doctor in charge saves each page of the survey form, the survey form information input / update unit 305 of the doctor side processing unit 300 in FIG. 5 stores the input information in the survey form information table 133 of the survey form information DB 113. .

  A screen for transmitting the survey form will be described with reference to FIGS. 17 (A) and 17 (B).

  When the doctor in charge finishes inputting all the pages of the survey form, the underlined number of the unsent item corresponding to the protocol to be transmitted to the pharmaceutical manufacturer person in charge is clicked from the protocol list 601 on the protocol selection screen 600 shown in FIG. To do. When the doctor in charge clicks, a patient selection screen 650 as shown in FIG. 17A is displayed.

  17A, the patient selection screen 650 has a display area 651 for displaying protocol information selected by the doctor in charge, a case list 652 for displaying a case list, and a return button 653 for returning to the previous screen.

  The case list 652 shows the status of displaying the survey form status for each case according to the transition of the survey form status in FIG. 3, patient name and sex, date of birth and case registration number, medical record number, starting date of administration and end of administration. Items such as date and patient background change.

  When the status item is “New Arrival”, this indicates that the pharmaceutical manufacturer person in charge has requested re-investigation (operation procedure 27). Further, “not sent” indicates that the survey form is being modified by the doctor in charge (operation procedure 28).

  For example, when the doctor in charge transmits the survey form of the patient name “Fujitaro”, the unsent 654 is clicked.

  When the doctor in charge clicks, a survey form selection screen 655 as shown in FIG. 17B is displayed.

  As shown in FIG. 17B, the survey form selection screen 655 shows a display area 656 for displaying the protocol information selected by the doctor in charge, patient information 657 indicating case information (patient information), and an operation for the selected survey form. An operation item 658 for displaying an item and a return button 660 for returning to the previous screen are provided.

  The doctor in charge confirms the contents of the displayed patient information 657 and clicks the transmission item value from the operation item 658 when transmitting the survey form. To delete, click the delete item value.

  When the doctor in charge clicks the transmission item value 659, a confirmation screen 661 is displayed. The doctor in charge clicks the OK button 662 when transmitting, and clicks the cancel button 663 when canceling the transmission.

  When the doctor in charge clicks an OK button 662 on the confirmation screen 661, the survey form transmitting unit 306 and the emergency event processing unit 307 of the doctor side processing unit 300 in FIG. 5 are activated. The survey form transmitting unit 306 changes the survey form status of the transmitted survey form in the survey form management information table 131 of the survey form information DB 113.

  The emergency event processing unit 307 determines whether there is an item for which the pre-set adverse event flag is on and information is input by the doctor in charge among the pages or items of the selected survey form. To check. For example, the pregnancy item 644 on the “patient background” page displayed in the survey form input area 640 in FIG. 13, or “adverse event 1”, “adverse event 2” in the page list shown in FIG. When information is input to pages such as “adverse event 3” and “comment about adverse event”, the emergency event processing unit 307 sends an email indicating that an emergency event has occurred to the pharmaceutical manufacturer (operation procedure 25). ).

  The mail transmitted to the pharmaceutical manufacturer and indicating that an emergency event has occurred includes, for example, the contents as shown in FIG.

  As shown in FIG. 18, the mail 669 indicating that an emergency event has occurred is a transmission destination 665, a message 666 that notifies that an emergency event has occurred, the name of the facility 667 that performed the investigation, and a case list that lists cases 668.

  The case list 668 shows, for example, a case registration number, a patient abbreviated name, date of birth, sex, and classification for each case.

  Such notifications to pharmaceutical manufacturers via email 669 allow pharmaceutical manufacturer personnel to immediately know that an emergency event has occurred and to refer to the questionnaire of the patient who experienced the emergency event, It is possible to promptly respond to patients and report to the Ministry of Health and Welfare.

  Next, the process of confirming the survey form information and the logic check by the pharmaceutical manufacturer person in charge in the operation procedure 26 will be described.

  From the survey form management screen 500 of FIG. 8, when the pharmaceutical manufacturer person clicks the incoming call 516 of the doctor “Shiro Itoyama”, for example, the survey form information confirmation unit 403 of the pharmaceutical manufacturer side processing unit 400 of FIG. Then, a survey form selection screen 700 as shown in FIG. 19A is displayed.

  19A, the survey form selection screen 700 has a display area 671 for displaying information on the protocol selected by the person in charge of the pharmaceutical manufacturer, a re-survey request button 672 for requesting a re-survey, and a re-survey request. It has a re-survey prompt button 673 for prompting later, a return button 674 for returning to the previous screen, and a survey form list 675 for displaying a list of survey forms.

  The survey form list 675 includes a survey form status, a survey form, a logical check, patient initials and sex, date of birth and case registration number, survey form name, and date when the survey form is completed. It has a survey form completion date indicating.

  The pharmaceutical manufacturer person in charge clicks the logic check button 678 to execute the logic check of the survey form whose status is “New Arrival”.

  When the pharmaceutical manufacturer person in charge clicks the logic check button 678, the logic check unit 404 of the pharmaceutical manufacturer side processing unit 400 in FIG. 5 is activated. The result of the logic check by the logic check unit 404 is notified to the person in charge of the pharmaceutical manufacturer through a logic check result screen 710 as shown in FIG.

  The pharmaceutical manufacturer person in charge clicks the close button 711 on the logic check result screen 710, and clicks the survey form item in the survey form list 675 on the survey form selection screen 700 in FIG. 19A.

  FIG. 20 is a diagram illustrating an example of the survey form information screen.

  As shown in FIG. 20, the survey form information screen 730 has a display area 741 for displaying information on the survey form selected by the person in charge of the pharmaceutical manufacturer, and a survey form display area 740 for inputting information to the survey form.

  The display area 741 is displayed in the display area 731 including the protocol name and the facility name, the display area 732 displaying the case information, the display area 733 displaying the survey form name and the survey form status, and the survey form display area 740. A page selection area 734 for selecting a page of the survey form, a return button 736 for returning to the previous screen, and a help button 737 for displaying an explanation of an input method to the survey form input screen and the like.

  The display area 732 displays a case number, patient name initials, gender, date of birth, chart number, and the like.

  The display area 733 displays the survey form name, the state displayed according to the doctor's survey form status shown in FIG.

  The page selection area 734 includes a selection input area for selecting a page, and a display switching button 735 for displaying the selected page.

  When the pharmaceutical manufacturer person in charge selects, for example, “patient background” from the page selection area 734 and clicks the display switching button 735, the “patient background” page is displayed in the survey form display area 740.

  In the “patient background” page of the survey form display area 740, two types of marks are attached to the items by logical check. Marks 744 to 746 indicate error items detected by a predetermined logic check.

  The pharmaceutical manufacturer person in charge can confirm the contents of the logic check error by clicking the ▲ mark. For example, when the ▲ mark 745 is clicked, a confirmation content screen 750 as shown in FIG. 21A is displayed.

  21A, the confirmation content screen 750 has a current logical check result 758 for displaying information on the current logical check error and a previous logical check result 759 for displaying information on the previous logical check error. . If this time is the detection of the first logic check error, the logic check result 759 is not displayed. If this is the third or more logic check error detection, the logic check results for the number of times are displayed.

  The current logical check result 758 includes a target item 751 that is a target of the logical check error, error information 752 indicating the content of the current logical check error, and details of the request from the verifier to the doctor in charge regarding the current logical check error. Input area 753, a save button 754 for saving the input error content, and a close button 755 for closing the screen without saving.

  The error information 752 includes items such as a confirmation check box, an error code for specifying an error, an error message indicating an error content, and data indicating input data. Check the confirmation check box to notify the doctor in charge of the error message.

  The previous logical check result 759 includes error information 756 indicating the content of the logical check error and a display area 757 for displaying the previous request content.

  The pharmaceutical manufacturer person in charge confirms the contents of the logic check error on the confirmation contents screen 750, enters the contents of the request for urging the doctor in charge into the input area 753, and puts a check mark in the confirmation check box of the error information 752. After that, the save button 754 is clicked. By clicking the save button 754, a save processing confirmation screen 760 as shown in FIG. 21B is displayed.

  As shown in FIG. 21B, the storage processing confirmation screen 760 includes a display area 761 indicating the logic check contents, a display area 762 displaying the request contents input by the person in charge of the pharmaceutical manufacturer, and a close button for closing the screen. 763.

  The person in charge of the pharmaceutical manufacturer confirms the contents stored on the storage processing confirmation screen 760, that is, the contents attached to the survey form and notified to the doctor in charge at the time of the re-survey request, and clicks the close button 763. The pharmaceutical manufacturer person in charge also performs the same processing for the ▲ marks 743 and 746 displayed in the survey form display area 740 of the survey form information screen 730 in FIG. 20 based on the confirmation content screen 750 and the storage processing confirmation screen 760. Do.

  In the survey form display area 740, items with “!” Marks 747 and 748 are not items detected by the logic check unit 404 of the pharmaceutical manufacturer side processing unit 400 in FIG. The mark is set in advance so that supplemental contents can be input.

  By clicking the “!” Mark 747 or 748, the pharmaceutical manufacturer person in charge can input a request item corresponding to the item to the doctor in charge. For example, when the pharmaceutical manufacturer person in charge clicks the “!” Mark 747, a confirmation content screen 765 as shown in FIG. 22 is displayed.

  As shown in FIG. 22, the confirmation content screen 765 includes a target item 766 that is the target, an input area 768 for inputting supplemental content from the pharmaceutical manufacturer person in charge to the doctor in charge, and a save button 769 for saving the supplemental content that has been entered. And a close button 770 for closing the screen without saving.

  When the pharmaceutical manufacturer person in charge inputs supplemental contents in the input area 768 and clicks the save button 769, the supplementary contents are attached to the survey form at the time of a re-survey request.

  Hereinafter, in the operation procedure 28 in FIG. 2, a correction process by the doctor in charge of the survey form requested by the pharmaceutical manufacturer person in charge of the re-survey will be described.

  The review screen provided to the doctor terminal will be described with reference to FIGS. 23 (A) to 23 (C).

  FIG. 23A shows a protocol list 772 showing another example of the protocol list investigated by the doctor in charge on the protocol selection screen 600 showing the same display configuration as FIG.

  In FIG. 23 (A), when the doctor in charge clicks on the new arrival item (value 2) corresponding to the protocol name “Pharmaceutical ABC”, the patient has a display configuration equivalent to FIG. 17 (A) shown in FIG. 23 (B). A selection screen 650 is displayed.

  In FIG. 23B, the doctor in charge clicks, for example, a state 776 (new arrival) corresponding to the patient name “Fujitaro” from the case list 775 having the item configuration equivalent to that in FIG. By clicking a state 776, a survey form selection screen 655 showing a display configuration equivalent to FIG. 17B shown in FIG. 23C is displayed. In this case, in the operation item 777 having an item configuration equivalent to that in FIG. 17B, the transmission item value and the deletion item value are “impossible”. That is, when the transmission status value is “new arrival”, the doctor in charge cannot transmit or delete the survey form.

  Therefore, it is possible to prevent the survey form from being deleted (lost) by mistake.

  In FIG. 23C, when the doctor in charge clicks, for example, the status item value 778 (new arrival) from the operation item 777 having the same item configuration as that in FIG. 17B, a re-survey as shown in FIG. The request details display screen is displayed.

  FIG. 24 is a diagram illustrating an example of a re-survey request content display screen.

  24, a re-survey request content display screen 780 shows a display configuration equivalent to the survey form information input 630 as the first example of FIG. However, the page name added with “*” may be displayed on the page selected by the page selection 634. A page name to which “*” is added indicates that there is an item to which a pharmaceutical manufacturer person in charge has attached request contents or supplementary contents.

  Therefore, the doctor in charge can know the page to be corrected by the page selection 634.

  The doctor in charge clicks the display switching button 635 to display the “* patient background” page in the survey form input area 640 and the “!” Mark in the patient background page displayed in the survey form input area 640 is added. Check the item that was added. When the “!” Mark is clicked, a confirmation content screen 783 is displayed.

  The confirmation content screen 783 has a close button 784 for closing the screen, and a display area 785 showing the request content.

  The display area 785 includes items such as an error content indicating the error content, an item name having the error, data input by the doctor, and a request content to the doctor in charge input by the pharmaceutical manufacturer person in charge. In this case, there is no entry in the disease duration and it is shown that “unknown” was not checked, and it can be seen that the pharmaceutical manufacturer person in charge has requested to input “10/20”.

  The doctor in charge confirms the contents of the request, clicks the close button 784, and requests the item to which the “!” Mark is added to the patient background page displayed in the survey form input area 640 of the re-survey request content display screen 780. Enter “10/20” based on the content. When the input to all the items with the “!” Mark is completed, the save button (not shown) is clicked to complete the correction of the “patient background” page.

  When the doctor in charge clicks the save button, the survey form information correction unit 308 of the doctor side processing unit 300 shown in FIG. 5 is activated, and the doctor in charge stores the item data corrected based on the request contents in the survey form information table 133. To do.

  After correcting the survey form, the doctor in charge transmits the survey form to the pharmaceutical manufacturer staff (operation procedure 29 in FIG. 2).

  The doctor in charge clicks on an untransmitted item value corresponding to the protocol to be transmitted from the protocol list 772 on the protocol selection screen 600 by the same operation in the operation procedure 26, and the patient in the case list 775 on the patient selection screen 650 Select. In this case, a re-survey selection screen 655 as shown in FIG. 25 is displayed.

  In the re-survey selection screen 655 in FIG. 25A, the operation item 788 having the same item configuration as that in FIG. 17B can be transmitted to the survey form name “survey form name 1”, but is deleted. Indicates that it is not possible.

  The doctor in charge clicks the transmission item value 789 of the operation item 778 and clicks the OK button 662 on the confirmation screen 661 displayed by this click, and the selected survey form is transmitted (operation procedure 29 in FIG. 2). .

  When the survey form is transmitted, as shown in FIG. 25B, the status item value of the operation item 788 on the survey form selection screen 655 is “sent”, and the transmission item value is “impossible”. . Further, a message 790 indicating that transmission has been completed is displayed.

  When the pharmaceutical manufacturer person in charge selects a plurality of survey forms as described above and makes a re-survey request to the doctor in charge, one re-survey request mail is transmitted for each doctor in charge.

  The survey form is repeatedly corrected until the input of the survey form is completed between the pharmaceutical manufacturer person in charge and the doctor in charge.

  From the above, all revisions of the survey form can be done using the screen provided by the survey form management system, so the pharmaceutical manufacturer person must visit the doctor in charge for each re-survey request There is no.

  In addition, request contents or supplement contents can be attached to each item that needs correction by the doctor in charge. Furthermore, the doctor in charge can refer to the attached request content or supplemental content at the display position of the item only by clicking the mark added to the item.

  Next, a description will be given of a survey form management system to which a function for improving the confidentiality of a survey form to be edited and a function for performing analysis and tabulation based on survey form data submitted by a doctor are described.

  FIG. 26 is a diagram illustrating another example of the functional configuration of the survey form management system. In FIG. 26, the same parts as those in FIG.

  26, the doctor-side processing unit 3001 of the survey form management system 1100 prevents falsification of the survey form based on the doctor's signature information, unlike the doctor-side processing unit 300 of the survey form management system 100 shown in FIG. The survey form information input / update unit 3051 is configured to include a survey form transmission unit 3062 that manages the transmission date and time of the survey form, and an image file storage unit 312 that manages image files of completed survey forms. Further, the pharmaceutical manufacturer side processing unit 4001 of the survey form management system 1100 is further analyzed by the pharmaceutical manufacturer based on the survey form in the difference from the pharmaceutical manufacturer side processing unit 400 of the survey form management system 100 shown in FIG. The analysis result providing unit 408 provides the doctor with the analysis result.

  Further, the database management unit 2001 of the survey form management system 1100 differs from the database management unit 200 of the survey form management system 100 shown in FIG. 5 in that the survey form management of the survey form information DB 113 that manages the image file for each survey form. It has an information table 1310 and an analysis result DB 116 that manages provision of analysis results of survey forms by pharmaceutical manufacturers to doctors.

  Processing in the survey form transmission unit 3062 and the image file storage unit 312 will be described with reference to FIGS.

  27A and 27B are flowcharts for explaining an example of the process for creating the image file of the survey form.

  FIG. 27A is a flowchart for explaining processing in the survey form transmitting unit.

  As shown in FIG. 27A, when the doctor in charge finishes inputting the survey form information (step S31) and transmits the survey form (step S32), the survey form transmitting unit 2062 uses the current time as the transmission date and time to send the survey form. Stored in the transmission date and time of the survey form managed by the management information table 1310.

  Further, the image file storage unit 312 is activated, for example, every 15 seconds in order to create an image file of a sent survey form, and performs processing according to the flowchart shown in FIG.

  FIG. 27B is a flowchart illustrating processing in the image file storage unit.

  27B, the image file storage unit 312 searches the survey form management information table 1310 for records in which the transmission date / time is not input and the image file storage date / time is not input (step S41).

  It is checked in step S41 whether a record has been searched (step S42). If no record is found, the process ends. On the other hand, when the record is searched, the survey form information is acquired from the survey form information table 133 based on the protocol ID for identifying the protocol from the retrieved record and the survey form ID for identifying the survey form. A PDF file is created based on the information (step S43).

  The PDF file of the survey form created in step S43 is stored in the survey form management information table 1310 as an image file of the survey form, and the current time is stored at the image file creation time (step S44).

  Next, the processing of the survey form information input / update unit 3051 will be described with reference to FIG.

  FIG. 28 is a flowchart illustrating an example of survey form management processing.

  28, the survey form information input / update unit 3051 acquires the input value and the signature information from the signature information DB 115 (step S81). In the case of new input, the input value and signature information are blank.

  The acquired input value is displayed on the doctor terminal 30 (step S82).

  When the doctor in charge presses the save button after inputting the survey form information (step S83), electronic authentication processing is executed at the doctor terminal 30, and a message digest encrypted with the doctor's private key is attached to the survey form information. And transmitted to the survey form management system 100 (step S84). The survey form information input / update unit 3051 determines whether or not the value obtained by decrypting the message digest encrypted with the doctor's private key with the public key of the doctor's signature information is correct (step S85). If it is not correct, a message indicating that it cannot be stored is displayed on the doctor terminal 30 (step S86), and the process ends. On the other hand, if they match, the input value and the signature information are stored in the signature information DB 115 (step S87), and the process ends.

  By the survey form management process, it is possible to prevent the survey form transmitted by the doctor in charge from being falsified and to authenticate whether the survey form information is input by the doctor in charge. The survey form information is updated only when the survey form is not falsified and the doctor in charge is authenticated.

  FIG. 29 is a diagram illustrating an example of the data structure of the survey form information record.

  From FIG. 29, the survey form information record managed in the survey form information table 113 has the data No. as the sequence number of the item data. , An item 62 indicating the input value input by the doctor in charge at the time of transmitting the survey form, an item 63 indicating the version number of the survey form, a message digest (MD) indicating encryption information, an item 64, and a doctor And an item 65 indicating the signature.

  Item 64 indicates the MD information encrypted with the doctor's private key.

  Item 65 is information for authenticating a doctor with the doctor's public key issued by the certification body.

  Information from items 61 to 65 is transmitted to the survey form management system 1100 when the doctor clicks the save button in steps S83 and S84 of FIG. In step S85 of FIG. 28, when the input value input by the doctor matches the signature information, items 61 to 65 are stored in the survey form information table 133 as one record.

  Next, a method for providing the analysis result of the survey form by the pharmaceutical manufacturer will be described with reference to FIGS. 30 (A) and 30 (B).

  30A and 30B show a flowchart for explaining an example of the process for providing the analysis result of the survey form.

  FIG. 30A is a flowchart for explaining analysis result registration by a pharmaceutical manufacturer.

  30A, the pharmaceutical manufacturer analyzes the incidence and the like based on the survey form information stored in the survey form information table 133, and stores the analysis result in the analysis information table 145 of the analysis result DB 116 (step S61) The user ID of the doctor in charge who can refer to the analysis result is registered in the providing doctor list 146 (step S62).

  FIG. 30B is a flowchart for explaining processing in the analysis information providing unit.

  30B, the analysis result providing unit 408 checks whether the user ID of the doctor in charge who is logged in is registered in the provided doctor list 146 (step S65). If registered, the analysis information is displayed on the doctor terminal 30 and can be downloaded by the doctor in charge (step S66). On the other hand, when not registered, the analysis information is not displayed, and a message indicating that the analysis information is not displayed is displayed on the doctor terminal 30 (step S67).

  Therefore, the pharmaceutical manufacturer can provide the analysis result of the survey form only to a specific doctor in charge, for example, the doctor in charge who requested the survey form.

  In the above embodiment, since the doctor in charge inputs information into the items of the survey form can be directly managed by the survey form management system, the pharmaceutical manufacturer person does not need to visit the doctor, and more than one pharmaceutical Data entry work by manufacturer personnel is unnecessary. In addition, data entry errors by pharmaceutical manufacturer personnel do not occur. Therefore, it is possible to greatly reduce labor by manpower, and it is possible to acquire the data itself input by the doctor in charge.

  Since the patient name entered by the attending doctor is automatically converted to initials, the attending doctor can also enter the patient's full name on the survey form. Furthermore, since the encrypted patient's full name and the converted initial are stored when the case is registered in the survey form management system, the confidentiality of the personal information can be protected.

  In addition, since the doctor in charge can manage the survey forms requested by a plurality of pharmaceutical manufacturer personnel in a unified survey form status, management of the survey forms becomes easy. Similarly, a pharmaceutical manufacturer person in charge can manage requests to a plurality of doctors in a unified survey form status, which facilitates management of the survey form.

  In the above example, the present invention is in a form applied to a post-marketing survey to collect information including side effects in practical use for an indication after it has been approved and marketed for an indication. It is not limited to this post-marketing survey. For example, the present invention can be applied to clinical trials for inferring how to treat a general population such as patients who generally need treatment in the future based on limited patient specimens.

  The present invention is not limited to the specifically disclosed embodiments, and various modifications and changes can be made without departing from the scope of the claims.

It is a figure which shows a network structure. It is a figure which shows the operation procedure at the time of utilizing a survey form management system. It is a figure which shows the example of a transition of survey form status. It is a figure which shows a hardware configuration. It is a figure which shows the example of a function structure of a survey form management system. It is a flowchart figure explaining an initial conversion process. It is a flowchart figure explaining the same case check process. It is a figure which shows the example of the survey form management screen provided to a pharmaceutical manufacturer terminal. It is a figure which shows the example of the contract facility input screen for a pharmaceutical manufacturer to input contract facility information. It is a figure which shows the example of the mail of a survey form input request. It is a figure which shows the example of the protocol selection screen provided to a doctor terminal. It is a figure which shows the example of the screen for inputting patient information. It is a figure which shows the example of a survey form information input screen. It is a figure which shows the example of a preservation | save process result screen. It is a figure which shows the other example of page selection. It is a figure which shows the other example of page selection. It is a figure which shows the example of the screen for transmitting a survey form. It is a figure which shows the example of the mail which notifies that an emergency event generate | occur | produced. It is a figure which shows the example of the survey form selection screen provided to a pharmaceutical manufacturer terminal. It is a figure which shows the example of a survey form information screen. It is a figure which shows the example of the confirmation screen of a logic check. It is a figure which shows the other example of a confirmation content screen. It is a figure which shows the example of the screen for re-survey provided to a doctor terminal. It is a figure which shows the example of a re-survey request content display screen. It is a figure which shows the example of the screen for transmitting the survey form which carried out the re-survey. It is a figure which shows the other example of a function structure of a survey form management system. It is a flowchart figure which shows the example of the creation process of the image file of a survey form. It is a flowchart figure which shows the example of a survey form management process. It is a figure which shows the example of the data structure of a survey form information record. It is a flowchart figure which shows the example of the provision process of the analysis result of a survey form.

Explanation of symbols

11 CPU
12 Memory unit 13 Output unit 14 Input unit 15 Display unit 16 Auxiliary storage device 17 CD-ROM driver 20 CD-ROM
B Bus 100 Survey form management system 111 Contract facility information DB
112 Case management information DB
113 Survey form information DB
114 Re-investigation request information DB
200 Database Management Department 300 Physician Processing Department 400 Pharmaceutical Manufacturer Processing Department

Claims (10)

One or more practitioner terminals, one or more verifier terminals, and a data verification support after drug sales using the performer terminal and a data verification support server connected to the verifier terminal via a network. A data verification support method to support,
The data verification support server includes a contract facility DB for registering and managing a contract facility for each medicine to be surveyed and a survey performer, a case management information DB for managing survey information on a patient registered by the practitioner, Having a survey form information DB for managing information on a survey form in which information on a patient after a pharmaceutical prescription entered by the practitioner is input, and a re-survey request information DB for managing a re-survey request to the survey form,
Supplying the survey form information relating to the pharmaceutical product requested to be surveyed from the verification support server to the operator terminal;
The practitioner terminal displays a survey form input screen corresponding to the survey form information for each medicine requested for the survey;
The patient terminal, when patient information prescribing the medicine requested to be surveyed is input, further displaying a logic check result;
Supplying the survey form registration information registered on the survey form screen from the implementer terminal to the data verification support server;
The data verification support server registers and manages the supplied survey form registration information in a survey form information DB;
Supplying the survey form registration information relating to the requested medicine from the verification support server to the verifier terminal;
The verifier terminal displays the survey form registration information, and further displays a logic check result;
The verifier terminal supplies the verification support server with re-survey request request information for the survey form registration information, or survey completion;
When the data verification support server determines that the re-survey request request information exists in the performer terminal, the re-survey request information relating to the drug requested for re-survey is supplied, and the version number of the re-request is managed. When,
The data verification support server supplies the survey form information to the implementer terminal each time the respective steps are performed on the survey form information and the re-survey form information. A state in which vote registration information is supplied; a state in which the survey form registration information is supplied to the verifier terminal; a state in which re-survey request request information is supplied from the verifier terminal; and the re-survey form information to the performer terminal In the status flag, at least four of the status where the re-survey form registration information is supplied from the performer terminal and the status where the survey completion is supplied from the verifier terminal is registered in the status flag. And supplying the progress state of data verification to the implementer terminal or the verifier terminal,
A data verification support method, characterized in that the survey form information includes at least input field arrangement information, prescription drug information, patient background information, treatment progress, and examination values.   2. The data verification support method according to claim 1, further comprising an initial conversion step of converting the personal name into an initial and encrypting the personal name.   2. The data verification support method according to claim 1, wherein the step of managing the survey form determines whether an emergency event has occurred, and transmits an emergency e-mail to the corresponding verifier terminal if it has occurred.   2. The data verification support method according to claim 1, wherein the logical check is performed by the data verification support server by requesting the logical verification from the implementer terminal or the verifier terminal to the data verification support server.   2. The data according to claim 1, wherein a process of determining whether the input item to which a logical check mark is added is logically correct is executed based on definition information of an item constituting the survey form. Verification support method. One or more practitioner terminals, one or more verifier terminals, and a data verification support after drug sales using the performer terminal and a data verification support server connected to the verifier terminal via a network. A data verification support system to support,
The data verification support server includes a contract facility DB for registering and managing a contract facility for each medicine to be surveyed and a survey performer, a case management information DB for managing survey information on a patient registered by the practitioner, Having a survey form information DB for managing information on a survey form in which information on a patient after a pharmaceutical prescription entered by the practitioner is input, and a re-survey request information DB for managing a re-survey request to the survey form,
Means for supplying the survey form information relating to the pharmaceutical product requested to be investigated from the verification support server to the implementer terminal;
The implementer terminal has means for displaying a survey form input screen corresponding to the survey form information for each medicine requested for the survey;
The practitioner terminal is further configured to display a logical check result when patient information prescribing the requested medicine is input;
Means for supplying survey form registration information registered on the survey form screen from the implementer terminal to the data verification support server;
The data verification support server includes means for registering and managing the supplied survey form registration information in a survey form information DB;
Means for supplying the survey form registration information relating to the medicine requested for the survey from the verification support server to the verifier terminal;
The verifier terminal displays the survey form registration information, and further displays a logical check result;
The verifier terminal supplies, to the verification support server, re-survey request request information for the survey form registration information, or means for supplying survey completion;
When the data verification support server determines that the re-survey request request information is present in the operator terminal, the data verification support server supplies re-survey form information related to the pharmaceutical requested for re-survey and manages the version number of the re-request When,
The data verification support server supplies the survey form information to the implementer terminal each time the respective steps are performed on the survey form information and the re-survey form information. A state in which vote registration information is supplied, a state in which the survey form registration information is supplied to the verifier terminal, a state in which reinvestigation request request information is supplied from the verifier terminal, and the re-survey form information to the performer terminal In the status flag, at least four of the status where the re-survey form registration information is supplied from the performer terminal and the status where the survey completion is supplied from the verifier terminal is registered in the status flag. And means for supplying a progress state of data verification to the implementer terminal or the verifier terminal;
A data verification support system characterized in that the survey form information includes at least arrangement information in the input fields, prescription drug information, patient background information, treatment progress, and examination values.   7. The data verification support system according to claim 6, further comprising initial conversion means for converting the personal name into an initial and encrypting the personal name.   7. The data verification support system according to claim 6, wherein the means for managing the survey form determines whether an emergency event has occurred, and transmits an emergency e-mail to the corresponding verifier terminal if it has occurred.   7. The data verification support system according to claim 6, wherein the logical check is performed by the data verification support server by requesting the logical verification from the implementer terminal or the verifier terminal to the data verification support server.   7. The data according to claim 6, wherein a process of determining whether or not an input item to which a logical check mark is added is logically correct is executed based on definition information of an item constituting the survey form. Verification support system.

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