CN107480456A - clinical trial management method and system - Google Patents

Abstract

The invention discloses a clinical trial management method and system, wherein, the method includes: obtaining test drug information, reviewing the test drug information according to the preset drug information, establishing test items according to the review results; constructing a test plan according to the test items; The protocol includes research content information and research stage information; collect subject information according to the test plan, and enter the subject information into the test plan; conduct relevant clinical trials based on the subject information and research stage information to obtain the corresponding Clinical trial data, and recorded into the trial protocol, complete clinical trial management. The present invention centrally manages the subjects through the test plan and records relevant data, which makes it convenient for the prescription and the supervision department to check, and the researcher can synchronize the real-time data at any time, realizing the diversified and integrated management of the clinical trial, reducing the need for clinical trials. The phenomenon of chaotic test data enhances the reliability of clinical pharmacological test results.

Description

Clinical trial management method and system

technical field

The invention relates to the technical field of information management, in particular to a clinical trial management method and system.

Background technique

Clinical trials are a complex experimental system involving many aspects such as pathology, pharmacology, ethics, and statistics. According to the definition of clinical trials in the "Quality Management Practices for Drug Clinical Trials" promulgated by the State Food and Drug Administration, clinical trials refer to any systematic research on drugs in humans (patients or healthy volunteers) to confirm or reveal the experimental drugs. The effect, adverse reactions and/or absorption, distribution, metabolism and excretion of the test drug, the purpose is to determine the efficacy and safety of the test drug. In foreign countries, people who participate in clinical trials are called volunteers, and in China they are generally called "subjects". Volunteers include healthy people and patients, which mainly depends on what kind of trial they are participating in. The trials that we have the most contact with usually involve patients. The purpose is to investigate whether new drugs have curative effects and whether they have side effects. Large tertiary hospitals undertake hundreds of experimental projects every year. They are entrusted by pharmaceutical companies to conduct clinical trial research for different periods of drug marketing. They need to recruit a large number of subjects to conduct subjects and observe drug responses.

At present, almost all hospitals still rely on some existing systems that have been used clinically in the hospital for the management of subjects, such as the outpatient clinic system, inpatient doctor order system, etc., so that the management of subjects is the same as that of ordinary patients. Due to the relative isolation of data between different systems, it is easy to cause many problems such as incomplete data records, lagging data transmission, random data design, unprofessional data statistical analysis, and non-standard management of subjects, resulting in many problems such as pharmaceutical prescriptions, drug use, etc. It is difficult for parties and regulatory authorities to verify, researchers cannot synchronize real-time data, and data confusion affects the reliability of clinical pharmacological test results.

Contents of the invention

The purpose of the present invention is to provide a clinical trial management method and system. The present invention centrally manages the subjects through the test plan and records relevant data, so that the prescriptions and regulatory authorities can be easily checked, and researchers can synchronize real-time data at any time to achieve It improves the diversified and integrated management of clinical trials, reduces the confusion of clinical trial data, and enhances the reliability of clinical pharmacological test results.

The invention provides a clinical trial management method, comprising the following steps:

Obtain the information of the experimental drug, review the information of the experimental drug according to the preset drug information, and establish the experimental project according to the review result;

Construct a test plan according to the test project; the test plan includes research content information and research phase information;

Collect subject information according to the test plan, and enter the subject information into the test plan;

According to the subject information and the research stage information, the relevant clinical trial of the research content information is carried out to obtain the corresponding clinical trial data, and record it into the trial plan to complete the clinical trial management.

As an implementable manner, said constructing a test scheme according to said test project includes the following steps:

Divide the test items to obtain research phase information;

Process the test items according to the research stage information to obtain research content information;

Combining the two-dimensional relationship according to the research stage information and the research content information, and connecting with the medical internal system through a communication protocol to generate a test plan.

As an implementable manner, said constructing a test scheme according to said test project also includes the following steps:

Before dividing the test items, the test type is set for the test items according to the preset researcher information and the corresponding authority, and the test type information is obtained.

As an implementable manner, said constructing a test scheme according to said test project also includes the following steps:

After the research content information is obtained, the research content information is classified to obtain classified content information.

As an implementable mode, the clinical trial management method provided by the present invention also includes the following steps:

After the relevant clinical trial of the research content information is carried out according to the subject information and the research stage information, the expense data is obtained, the accounting process is performed according to the expense data, and a multi-dimensional financial statement is generated.

Correspondingly, the present invention also provides a clinical trial management system, including a trial drug acquisition module, a trial protocol construction module, a subject entry module, and a clinical trial management module;

The test drug acquisition module is used to obtain test drug information, review the test drug information according to the preset drug information, and establish test items according to the review results;

The test plan building module is used to construct a test plan according to the test project; the test plan includes research content information and research phase information;

The subject input module is used to collect subject information according to the test plan, and enter the subject information into the test plan;

The clinical trial management module is used to conduct clinical trials related to the research content information according to the subject information according to the research stage information, obtain corresponding clinical trial data, and record them into the trial plan to complete the clinical trials. Trial management.

As an implementable manner, the test plan building module includes a division unit, a processing unit and a combination unit;

The division unit is used to divide the test items to obtain research phase information;

The processing unit is configured to process the test items according to the research stage information to obtain research content information;

The combination unit is used to combine the two-dimensional relationship according to the research stage information and the research content information, and connect with the medical internal system through a communication protocol to generate a test plan.

As an implementable manner, the construction module of the test scheme also includes a setting unit;

The setting unit is configured to set the test type for the test item according to the preset researcher information and the corresponding authority before dividing the test item, and obtain the test type information.

As an implementable manner, the test protocol building block also includes a classification unit;

The classification unit is configured to classify the research content information after obtaining the research content information to obtain classified content information.

As an implementable manner, the clinical trial management module also includes a financial statement unit;

The financial statement unit is used to obtain expense data after conducting relevant clinical trials of the research content information according to the subject information and the research stage information, perform accounting processing according to the expense data, and generate Multidimensional financial statements.

Compared with the prior art, the technical test scheme has the following advantages:

In the clinical trial management method and system provided by the present invention, firstly, the trial drug information is reviewed according to the preset drug information, the test items are established according to the review results, and the test program is constructed according to the test items; the recruitment of subjects is completed through the constructed test program, According to the research stage information of the trial protocol, the relevant clinical trials of the research content information are carried out to complete the clinical trial management of the subjects. The subjects are managed centrally through the test plan, and relevant data are recorded, which makes it easy for the prescription and the regulatory department to check. The researchers synchronize real-time data at any time, realizing the diversified and integrated management of clinical trials, and reducing clinical trial data. The phenomenon of confusion enhances the reliability of clinical pharmacological test results.

Description of drawings

FIG. 1 is a schematic flow diagram of a clinical trial management method provided in Embodiment 1 of the present invention;

Fig. 2 is the schematic flow chart of setting up test project in Fig. 1;

FIG. 3 is a schematic structural diagram of a clinical trial management system provided in Embodiment 2 of the present invention.

In the figure: 100, test drug acquisition module; 200, test protocol building module; 210, setting unit; 220, division unit; 230, processing unit; 240, classification unit; 250, combination unit; 300, subject entry module; 400. Clinical trial management module; 410. Financial statement unit.

detailed description

The above and other technical features and advantages of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Apparently, the described embodiments are only some of the embodiments of the present invention, not all of them.

Please refer to Figure 1, the clinical trial management method provided by Embodiment 1 of the present invention includes the following steps:

S100. Acquire the information of the experimental drug, review the information of the experimental drug according to the preset drug information, and establish a test item according to the review result;

S200. Construct a test plan according to the test project; the test plan includes research content information and research stage information;

S300. Collect subject information according to the test plan, and enter the subject information into the test plan;

S400 , according to the subject information and the research stage information, conduct the relevant clinical trial of the research content information, obtain the corresponding clinical trial data, and record it into the trial plan, and complete the clinical trial management.

It should be noted that after signing the relevant project contract, the pharmacy of the trial drug center will complete the acquisition of the trial drug information, which can be directly input manually and/or scanned. Then enter the experimental drug information into the pharmacy database to obtain the experimental drug database; thereby separating the experimental drug from the normal drug and avoiding the data confusion of the experimental drug information. The preset drug information is the standard information of each test drug, which is reviewed by comparing, judging, and screening the preset drug information with the test drug information, and establishing the test project after the review is passed. The trial drug information that needs to be reviewed includes not only the basic information of the trial drug, batch information, expiration date information, and serial number information. It also includes the data generated after each operation of the experimental drug, such as inventory information, storage information, drug filling operation, drug prescription review, department review of drug recall, manufacturer's drug recall, etc.

As shown in Figure 2, the specific process of establishing a trial project includes project application, ethics review, contract signing, drug library establishment, and kick-off meeting.

S110. Project application includes project reporting and review, project reporting, the account number of the personnel in the hospital is directly generated by importing the personnel information through the connection between the pilot project and the hospital OA system, and the personnel outside the hospital need to register an account in the pilot project, and then after the review Generated; and it is necessary to assign corresponding permissions to unused user accounts, which can be defined by assigning different roles (roles can be divided into sponsor, researcher, project leader, department director, institutional office secretary, institutional office director, etc.); the sponsor will fill in the project online after logging in to the trial project, and upload the project information. After confirming the submission, it will enter the review stage. The review stage can be divided into person-in-charge review, department director review, and institution office review. After entering the system, the user can see the current to-do tasks in "My To-Do" (based on task-driven process management). During the review process, the online review of project materials can be carried out and the review information can be extracted as the reason for project rejection. After the institutional review is passed, the project will generate a unique acceptance number, which greatly reduces the workload of project review; through the online reporting of the project, a test project database of the whole hospital will be successfully created, and project-related information and project data can be searched and viewed in association , and users with different roles have different operation permissions and project viewing permissions in different scopes (I fill in the project, I am in charge of the project, a professional group project, the whole hospital project, etc.).

S120. Ethical review is a stage that enters after the project applicant has passed the review. Ethical review includes initial review, amendment review, continuous review, detection and evaluation of adverse events, etc. Different review types need to fill in different application content but Have the same process management; the project leader applies for ethics review online, fills in the application content and uploads ethics materials, and after confirmation and submission, the ethics secretary conducts the formal review of the project. After the formal review is passed, two chief reviewers are assigned to each project. Review, review the project content and project materials during the review process, and submit the review results. After the ethics meeting, you can perform online sign-in of the ethics meeting members in the system, check the ethics materials submitted by the project online, and the ethics secretary Online filling of meeting minutes, online voting on ethical review results, etc., the system can automatically reject or pass the project according to the voting results, and the ethical approval document can be generated online for projects that pass the ethical review.

S130. Contract management is a stage that enters after the ethics review is passed and the ethics approval document is successfully obtained. After the project contract is successfully signed, it is necessary to immediately enter the important information of the contract (such as the cost information specified in the contract, etc.) into the system, and scan the contract After the contract entry is completed, a unique contract number will be produced for each project, and the contract number will be used as the unique identifier of the project during the subsequent process.

S140. Establishing the drug library is a stage entered after the contract management is passed and successful. The trial drug information is reviewed and stored according to the preset drug information, and then the drug library is established according to the trial drug information.

The kick-off meeting is a stage entered after the contract management is passed and successful. This stage can be carried out or skipped directly.

The test plan is constructed strictly with reference to the corresponding test items. The test plan defines the data that each subject needs to conduct corresponding research content information and evaluation information in the corresponding research phase information (research phase cycle with a certain time range). surface. Evaluation information is included in the clinical trial data. Clinical trials are carried out in periodic stages, and the trial cycles of different experimental drugs are generally different; therefore, the trial items are divided to obtain the research stage information. The research stage information here can be the screening period, trial cycle, treatment suspension, follow-up, etc.; and specify the start time and end time of the stage as required. The research content information is the research content that needs to be carried out in the corresponding research phase, which can be informed consent, enrollment, physical examination, combined medication, tumor assessment, drug administration, vital signs, adverse events, etc. In other embodiments, information such as the content of the trial protocol and eCRF (electronic case report of subjects) can also be added to the trial protocol.

What needs to be explained about the collection of subject information is that firstly, the recruited subject information is screened according to the test plan, and the subject information conforming to the test plan is screened out, and the subject information is entered in the chronological order of recruitment. , you can also directly complete the screening and entry of subject information from the existing internal system of the hospital through the communication protocol through the patient's card number/medical record number in the hospital; for example, on the subject recruitment page, the screening number is automatically entered according to the rules. Generate, select the subject type (outpatient/inpatient), enter the card number/medical record number to search, and the data will be directly obtained from HIS through WebService or HttpClient, greatly reducing the time for information input; after confirming that the information is correct, click the "Save" button, Judgments will be made according to the rules, such as whether they have participated in other trials within three months, whether outpatients pretend to be inpatients, whether inpatients participate in other outpatient trials, etc. After successful addition, subjects will appear on the left Menu, different colors indicate the status of the subject (normal test, screening failed, excluded, etc.).

In the clinical trial management method provided by the present invention, first, the trial drug information is reviewed according to the preset drug information, the test items are established according to the review results, and the test program is constructed according to the test items; the recruitment of subjects is completed through the constructed test program, and according to The research stage information of the trial protocol carries out the relevant clinical trial of the research content information and completes the clinical trial management of the subjects. The subjects are managed centrally through the test plan, and relevant data are recorded, which makes it easy for the prescription and the regulatory department to check. The researchers synchronize real-time data at any time, realizing the diversified and integrated management of clinical trials, and reducing clinical trial data. The phenomenon of confusion enhances the reliability of clinical pharmacological test results.

Further, step S200 includes the following steps:

S210. Divide the test items to obtain research phase information;

S220. Process the experimental items according to the research stage information to obtain research content information;

S230. Combining two-dimensional relationships according to the research stage information and research content information, and connecting with the medical internal system through a communication protocol to generate a test plan.

The design of the test plan: Based on the modular and configurable design idea, the behavior of the following subjects is based on the test plan. The test plan can be decomposed into a two-dimensional relationship, y is the research content, and x is the research stage , forming a two-dimensional relationship between them. Clinical trials are carried out in periodic stages, and the trial cycles of different experimental drugs are generally different; therefore, the trial items are divided to obtain the research stage information. The research stage information sets the time range of each stage, and according to the corresponding time range of the stage, the time expectation reminder (drug administration time, etc.), early warning, etc. are given to the subjects in the whole test in advance; the research content information is the corresponding Specific clinical behaviors include laboratory tests, medical technical examinations, drug prescribing, informed consent, enrollment screening, eCRF, etc. Clinical trial management in accordance with the trial protocol will greatly reduce the operating cost of the later recruitment of the subject (the relationship between the trial protocol and the subject is 1:n), and also strictly frame the clinical behavior of the subject in the trial protocol Based on the design of the clinical trial, it provides a basis for the quality control of the clinical trial; the eCRF (subject electronic medical record report) is performed according to the medical record report format specified in each trial protocol, and is used for filling in the medical records related to the subjects in the later stage. In the test plan, some rules can also be set according to the research content information; for example, the screening number rule (defining the number of digits and combination content of the screening number, which is used to automatically generate the corresponding screening number when the subject is screened), the inclusion and exclusion criteria ( The inclusion and exclusion criteria stipulated in the trial protocol, if the main subject does not meet any of the inclusion rules or meets any of the exclusion criteria, the subject will fail to screen), the time point rules for pk blood collection/urine collection ( Design time points for continuous sampling, such as +0h, +0.5h, +1h, +1.25h, +1.5h, +2.0h, etc. Time sampling, the system automatically calculates the theoretical blood sampling time) and other rules according to the time point rule and then referring to the administration time. The test plan realizes the centralized management of all the behaviors of the subjects from the vertical dimension (centralized management of the clinical behaviors of all the subjects of a single project, which is very intuitive to reflect the situation of all the subjects of the project), and realizes the clinical trials from the horizontal dimension Integrated management (from the enrollment of a single subject after the informed consent to the successful completion of the subject's entire process management of the trial).

Combine the two-dimensional relationship according to the research stage information and research content information, and connect with the medical internal system through the communication protocol; for example, directly obtain the existing subject information data from HIS through WebService or HttpClient; or from LIS, Acquire the data to be used in PACS; seamlessly connect with the hospital system HIS, LIS, PACS, etc., making it relatively independent but not isolated (there will still be data in the hospital system), and linking data of different granularities together, It is difficult to present the research data comprehensively.

Further, step S200 also includes the following steps:

Before dividing the test items, the test type is set for the test items according to the preset researcher information and the corresponding authority, and the test type information is obtained.

It should be noted that, according to the test type information of the test plan corresponding to the test item setting, the test type of the test item is set according to the preset researcher information and the corresponding authority; the test type information includes open, single-blind and double-blind Three types; the type used to distinguish the test directly affects the way of prescribing the late test prescription; the preset researchers include investigators, research nurses, drug management, CRC, etc., and different researchers correspond to different authorities. If it is open, the number (characteristic information) of the test drug will be directly confirmed when the doctor prescribes to realize the collection of prescription information; if it is single-blind/double-blind, the number of the test drug will not be checked when the doctor prescribes. Select, when the research nurse goes to the test pharmacy to pick up the medicine, then input the serial number of the test drug to realize the collection of prescription information. Subsequent outbound processing.

Further, step S200 also includes the following steps:

After the research content information is obtained, the research content information is classified to obtain the classified content information.

Classify the research content information, which can be divided into CRF, inspection, inspection, drug administration, etc. The purpose of classifying content information is to realize that the subjects can design differentiated execution methods for different research content platforms, and finally the independent research stage Information and research content information are combined through a two-dimensional relationship to realize the corresponding research content corresponding to different research stages, and realize the diversification and integration of clinical trials.

Further, the clinical trial management method also includes the following steps:

After conducting relevant clinical trials with research content information based on subject information and research stage information, cost data is obtained, and accounting processing is performed based on cost data, and multidimensional financial statements are generated.

Examples of multi-dimensional financial statements generated by subjects in accordance with the test protocol for relevant clinical trials:

In the subject management area, the stage of a new subject is the first stage by default, and all to-do tasks in this stage will be displayed, task-driven, complete all tasks to enter the next stage, and the multi-tab page at the bottom Dynamically display the research content corresponding to this stage (dynamic changes according to the stage). Due to the difference between the outpatient process and the inpatient process, each click on the subject will check the subject type with the information in the hospital's HIS system through WebService or HttpClient (Outpatient or inpatient), change the subject type in time, the type of subject (outpatient/hospitalization) will affect the actual implementation path of the research content; inspection/inspection is in accordance with the definition of the cycle in the trial protocol Acquired, batch execution is enough, the system automatically bills (no advance payment is required), outpatients go directly to the window to draw blood/registration, inpatients can follow the hospitalization process, and additional bills that are not defined in the trial plan can go to " "Additional billing" is issued, and the reason for billing needs to be stated; all test/check results of the subject can be viewed in the historical test/check list, which is divided into different project cycles and different patient types (outpatient/inpatient), automatically Extract abnormal indicators and remind researchers to report AEs (abnormal events); select the ordering drug (drugs put into storage for this project), select the number (select the corresponding number for open trials, do not select for single-blind/double-blind), and bill the doctor After checking, they will go to the pharmacy to place the medicine (can be invalidated or canceled during the period), and the corresponding person will go to the pharmacy of the test center to pick up the medicine. In the historical prescription list, all the new drug prescriptions of the subject can be viewed. The drug withdrawal operation can be carried out, and the reasons should be stated (the sponsor’s certification documents are required), and the pharmacy has a confirmation operation, and each department will return the drug to the pharmacy of the test center, and the pharmacy administrator will check;

When the above-mentioned subjects conduct relevant clinical trials according to the trial plan, data statistics and report input will be carried out after the research content of each research stage is completed, and the management department of the clinical trial institution will be able to monitor the progress of each project of each professional group in real time , and display financial data in multiple dimensions for the financial department of the hospital to settle expenses with the manufacturer. After all clinical trials recruit subjects, the test subjects and medical technical examinations required for drug research are all free of charge, and the pharmaceutical company will settle with the hospital in accordance with the generated multi-dimensional financial statements to successfully settle the test cases. There is no need for the complicated operation of the subject to pay the expenses in advance and then reimbursement, which will ensure the quality of the trial while facilitating the clinical trial.

Based on the same inventive concept, an embodiment of the present invention also provides a clinical trial management system. The implementation of the system can be realized by referring to the process of the above method, and the repetition will not be repeated.

As shown in FIG. 3 , it is a schematic structural diagram of the clinical trial management system provided by Embodiment 2 of the present invention, including a trial drug acquisition module 100, a trial protocol construction module 200, a subject entry module 300, and a clinical trial management module 400;

The test drug acquisition module 100 is used to acquire test drug information, review the test drug information according to the preset drug information, and establish test items according to the review results;

The test plan construction module 200 is used to construct the test plan according to the test items; the test plan includes research content information and research stage information;

The subject input module 300 is used to collect subject information according to the test plan, and enter the subject information into the test plan;

The clinical trial management module 400 is used to conduct clinical trials related to research content information according to subject information and research stage information, obtain corresponding clinical trial data, and record them into the trial protocol to complete clinical trial management.

Further, the test plan construction module 200 includes a division unit 220, a processing unit 230 and a combination unit 250;

The division unit 220 is used to divide the test items to obtain research phase information;

The processing unit 230 is used to process the test items according to the research stage information to obtain the research content information;

The combination unit 250 is used to combine the two-dimensional relationship according to the research stage information and the research content information, and connect with the medical internal system through a communication protocol to generate a test plan.

Further, the test plan construction module 200 also includes a setting unit 210;

The setting unit 210 is used to set the test type for the test project according to the preset researcher information and the corresponding authority before dividing the test project, and obtain the test type information;

Assign researchers and set corresponding permissions according to the test type information.

Further, the test plan construction module 200 also includes a classification unit 240;

The classification unit 240 is configured to classify the research content information after obtaining the research content information to obtain classified content information.

Further, the clinical trial management module 400 also includes a financial statement unit 410;

The financial statement unit 410 is used to obtain expense data after conducting relevant clinical trials of research content information according to subject information and research stage information, perform accounting processing according to expense data, and generate multidimensional financial statements.

The clinical trial management system provided by the present invention first reviews the trial drug information according to the preset drug information, establishes the test items according to the review results, and then constructs the test program according to the test items; completes the recruitment of subjects through the constructed test program, and The research stage information of the trial protocol carries out the relevant clinical trial of the research content information and completes the clinical trial management of the subjects. The subjects are managed centrally through the test plan, and relevant data are recorded, which makes it easy for the prescription and the regulatory department to check. The researchers synchronize real-time data at any time, realizing the diversified and integrated management of clinical trials, and reducing clinical trial data. The phenomenon of confusion enhances the reliability of clinical pharmacological test results.

Although the present invention has been disclosed as above with preferred embodiments, it is not intended to limit the present invention, and any person skilled in the art can use the methods disclosed above and technical content to analyze the present invention without departing from the spirit and scope of the present invention. Therefore, any simple modifications, equivalent changes and modifications made to the above embodiments according to the technical essence of the present invention, which do not depart from the content of the technical test plan of the present invention, all belong to the technical aspects of the present invention. Scope of protection of the trial protocol.

Claims (10)

1. A kind of 1. clinical trial management method, it is characterised in that comprise the following steps：

   Trial drug information is obtained, the trial drug information is audited according to default drug information, according to auditing result Establish pilot project；

   Testing program is built according to the pilot project；The testing program includes research contents information and conceptual phase information；

   Subject information is gathered according to the testing program, by testing program described in subject information's typing；

   The relevant clinical that the research contents information is carried out according to the conceptual phase information according to the subject information is tested, Corresponding clinical testing data is obtained, and is recorded into the testing program, completes clinical trial management.
2. 2. clinical trial management method as claimed in claim 1, it is characterised in that described built according to the pilot project is tried Proved recipe case, comprises the following steps：

   The pilot project is divided, obtains conceptual phase information；

   The pilot project is handled according to conceptual phase information, obtains research contents information；

   Two-dimentional relation combination is carried out according to the conceptual phase information and the research contents information, and passes through communications protocol and doctor Business built-in system is docked, and generates testing program.
3. 3. clinical trial management method as claimed in claim 2, it is characterised in that described built according to the pilot project is tried Proved recipe case, it is further comprising the steps of：

   Before the pilot project is divided, according to default researcher's information and corresponding authority to described Testing items setting test type, obtain test type information.
4. 4. clinical trial management method as claimed in claim 2, it is characterised in that described built according to the pilot project is tried Proved recipe case, it is further comprising the steps of：

   After research contents information is obtained, the research contents information is classified, obtains classifies content information.
5. 5. clinical trial management method as claimed in claim 1, it is characterised in that further comprising the steps of：

   Tried in the relevant clinical for carrying out the research contents information according to the conceptual phase information according to the subject information After testing, cost data is obtained, book keeping operation processing is carried out according to the cost data, and generate multidimensional financial statement.
6. A kind of 6. clinical trial management system, it is characterised in that including trial drug acquisition module, testing program structure module, Subject's recording module and clinical trial management module；

   The trial drug acquisition module, for obtaining trial drug information, according to default drug information to the trial drug Information is audited, and pilot project is established according to auditing result；

   The testing program builds module, for building testing program according to the pilot project；The testing program includes grinding Study carefully content information and conceptual phase information；

   Subject's recording module, for gathering subject information according to the testing program, the subject information is recorded Enter in the testing program；

   The clinical trial management module, for according to the subject information according to the conceptual phase information carry out described in grind Study carefully the relevant clinical experiment of content information, obtain corresponding clinical testing data, and record into the testing program, complete clinical Trial.
7. 7. clinical trial management system as claimed in claim 6, it is characterised in that the testing program structure module includes drawing Subdivision, processing unit and assembled unit；

   The division unit, for the pilot project to be divided, obtain conceptual phase information；

   The processing unit, for the pilot project to be handled according to conceptual phase information, obtain research contents information；

   The assembled unit, for carrying out two-dimentional relation combination according to the conceptual phase information and the research contents information, And docked by communications protocol with medical matters built-in system, generate testing program.
8. 8. clinical trial management system as claimed in claim 7, it is characterised in that the testing program builds module, also wraps Include setting unit；

   The setting unit, for before the pilot project is divided, according to default researcher's information and with Its corresponding authority obtains test type information to the Testing items setting test type.
9. 9. clinical trial management system as claimed in claim 7, it is characterised in that the testing program builds module, also wraps Include taxon；

   The taxon, for after research contents information is obtained, classifying to the research contents information, being divided Class content information.
10. 10. clinical trial management system as claimed in claim 6, it is characterised in that the clinical trial management module is also wrapped Include financial statement unit；

    The financial statement unit, for carrying out the research according to the conceptual phase information according to the subject information After the relevant clinical experiment of content information, cost data is obtained, book keeping operation processing is carried out according to the cost data, and generate more Tie up financial statement.