CN112562801A - Big data processing system and method for clinical evaluation research of new drugs - Google Patents
Big data processing system and method for clinical evaluation research of new drugs Download PDFInfo
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Abstract
The invention provides a big data processing system and a big data processing method for clinical evaluation research of a new medicine, and relates to the technical field of information management. The invention provides a big data processing system for clinical evaluation research of new drugs, which comprises: the item selection module is used for displaying and determining the current item; the data display module is used for displaying relevant data information of the current project book center; a subject correlation module for user management of subject information; and the information processed by the item selection module, the data presentation module and the subject correlation module has an association relation in the database. Data of a plurality of centers are integrated on the system, so that the workload of connecting each heterogeneous application system is reduced, the coupling degree between heterogeneous systems is reduced, the flexibility and the response speed of the system are improved, the data management is facilitated, and the reliability of clinical pharmacological test results is improved.
Description
Technical Field
The invention relates to the technical field of information management, in particular to a big data processing system and a big data processing method for clinical evaluation research of new drugs.
Background
Clinical trials refer to systematic studies of drugs in human body (patients or healthy volunteers) to study information such as action and adverse reaction of the drugs in the tests, and the purpose of the studies is to determine the efficacy and safety of the drugs in the tests.
Almost all hospitals today rely on existing systems that are already in use in the hospital clinic, such as outpatient systems, hospitalization systems, etc., so that subject management fulfills a fundamental need as common patients do.
However, data among different systems are relatively isolated, so that management confusion is easily caused, and the reliability of the clinical pharmacological test result is influenced.
Disclosure of Invention
Technical problem to be solved
Aiming at the defects of the prior art, the invention provides a big data processing system and a big data processing method for clinical evaluation research of new drugs, and solves the technical problems that the clinical test data among different systems are relatively isolated, the management is easy to be disordered, and the reliability of the clinical pharmacological test result is influenced.
(II) technical scheme
In order to achieve the purpose, the invention is realized by the following technical scheme:
a big data processing system for clinical evaluation studies of new drugs, comprising:
the item selection module is used for displaying and determining the current item;
the data display module is used for displaying relevant data information of the current project book center;
a subject correlation module for user management of subject information;
the information processed by the item selection module, the data display module and the subject correlation module has an incidence relation in the database.
Preferably, the relevant data information displayed by the data display module comprises study units, subject enrollment and subject status.
Preferably, the subject-related modules include a subject screening module and a subject management module;
the subject screening module is used for inputting the added patient information, checking the added patient into a group and quickly searching the appointed patient;
the subject management module is used for viewing the information of the grouped subjects, adding visits for the subjects, crf entering and saving, rapidly searching the subjects and dropping the subjects.
Preferably, the big data processing system further comprises:
and the user management module is used for distributing an account and a password for the user.
Preferably, the big data processing system further comprises:
and the log module is used for recording login information generated under the current user account and recording system operation information of the current user account.
Preferably, the big data processing system further comprises:
and the progress monitoring module is used for providing a real-time data overview function of the progress of each center, a real-time display function of the group entering progress of each center and a display function of the operation record of each center.
Preferably, the big data processing system further comprises:
the information checking module is used for providing a real-time mandatory item checking function; and/or
The password setting module is used for setting and changing the current login password; and/or
And the item switching module is used for switching among the items when the user participates in a plurality of items simultaneously.
A big data processing method for new drug clinical evaluation research, comprising the step of processing big data of new drug clinical evaluation research by using the big data processing system for new drug clinical evaluation research as any one of the above.
(III) advantageous effects
The invention provides a big data processing system and a big data processing method for clinical evaluation research of new drugs. Compared with the prior art, the method has the following beneficial effects:
the invention provides a big data processing system for clinical evaluation research of new drugs, which comprises: the item selection module is used for displaying and determining the current item; the data display module is used for displaying relevant data information of the current project book center; a subject correlation module for user management of subject information; and the information processed by the item selection module, the data presentation module and the subject correlation module has an association relation in the database. Data of a plurality of centers are integrated on the system, so that the workload of connecting each heterogeneous application system is reduced, the coupling degree between heterogeneous systems is reduced, the flexibility and the response speed of the system are improved, the data management is facilitated, and the reliability of clinical pharmacological test results is improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a block diagram of a big data processing system for clinical evaluation research of new drugs according to an embodiment of the present invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are clearly and completely described, and it is obvious that the described embodiments are a part of the embodiments of the present invention, but not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The embodiment of the application provides a big data processing system and a big data processing method for clinical evaluation research of new drugs, solves the technical problems that the clinical test data among different systems are relatively isolated, the management is easily disordered, and the reliability of the clinical pharmacological test result is influenced, and realizes the beneficial effect of improving the reliability of the clinical pharmacological test result.
In order to solve the technical problems, the general idea of the embodiment of the application is as follows:
the big data processing system for the clinical evaluation research of the new drug provided by the embodiment of the invention comprises: the item selection module is used for displaying and determining the current item; the data display module is used for displaying relevant data information of the current project book center; a subject correlation module for user management of subject information; and the information processed by the item selection module, the data presentation module and the subject correlation module has an association relation in the database. Data of a plurality of centers are integrated on the system, so that the workload of connecting each heterogeneous application system is reduced, the coupling degree between heterogeneous systems is reduced, the flexibility and the response speed of the system are improved, the data management is facilitated, and the reliability of clinical pharmacological test results is improved.
In order to better understand the technical solution, the technical solution will be described in detail with reference to the drawings and the specific embodiments.
As shown in the figure, the embodiment of the present invention provides a big data processing system for clinical evaluation research of new drugs, including:
the item selection module is used for displaying and determining the current item;
the data display module is used for displaying relevant data information of the current project book center;
a subject correlation module for user management of subject information;
the information processed by the item selection module, the data display module and the subject correlation module has an incidence relation in the database.
In the embodiment of the invention, data of a plurality of centers are integrated on one system, so that the workload of connecting each heterogeneous application system is reduced, the coupling degree among heterogeneous systems is reduced, the flexibility and the response speed of the system are improved, the data management is facilitated, and the reliability of clinical pharmacological test results is further improved.
Example (b):
in a first aspect, as shown in fig. 1, an embodiment of the present invention provides a big data processing system for clinical evaluation research of new drugs, which specifically includes:
and the item selection module is used for displaying and determining the current item.
The data display module is used for displaying relevant data information of the current project book center; the relevant data information displayed by the data display module comprises research units, the candidate condition of the subject and the state of the subject. Specifically, the method comprises the following steps:
(1) study Unit and Subjects enrollment
1) The total number of patients to be screened corresponds to the total number of all added patients in the center of the current project book;
2) the total number of grouped subjects corresponds to the total number of grouped subjects in the current project book center;
3) [ grouping Rate ] was obtained as the number of subjects to be grouped/the number of subjects to be screened ×%.
(2) Subject status
1) The total number corresponds to the total number of grouped subjects, which is 100 percent of the total number of grouped subjects in the statistical project;
2) (completed) subjects who completed all trials according to the project study protocol;
3) (not complete) corresponds to "subject management" - "complete status" as completed subject;
4) [ abscission ] subjects who stopped the test and were marked as "abscission".
And the subject correlation module is used for managing the subject information by the user. The subject-related modules include a subject screening module and a subject management module;
the subject screening module is used for inputting the added patient information, checking the added patient into a group and quickly searching the appointed patient.
The screening number in the entered and added patient information is automatically generated by a system, and the abbreviation of the patient name is filled by referring to a certain abbreviation rule;
the checking and grouping of the added patients means that a user can screen the patients to determine whether the patients can enter the group or not and the grouping condition after entering the group, after the patients meeting the grouping standard enter the group, the state in the list shows that the patients are grouped, the patients not meeting the grouping standard can not enter the group, the state in the list shows that the patients are not grouped, the patients formally become the testees after entering the group, and the information is automatically synchronized into the list of the testee management module.
The subject management module is used for viewing grouped subject information, adding visits for subjects, crf (case report form) entry and storage, rapidly searching subjects and dropping subjects.
The adding an visit to the subject comprises adding a date of the visit;
the falling subject corresponds to a user who manually falls the subject, and the falling reason needs to be recorded when the subject falls.
The information processed by the item selection module, the data display module and the subject correlation module has an incidence relation in the database.
The big data processing system for clinical evaluation research of new drugs further comprises:
and the user management module is used for distributing an account and a password for the user.
The log module is used for recording login information generated under the current user account, and the login information comprises login time and login IP; and the system is also used for recording the system operation information of the current user account.
And the progress monitoring module is used for providing a real-time data overview function of the progress of each center, a real-time display function of the group entering progress of each center and a display function of the operation record of each center. Through the module, the overall center PI can dynamically control project progress.
The 'project total progress information' is shown in the page header of the system: (1) displaying the project overall data according to conditions; (2) displaying the project overall data according to the actual progress condition of each center;
the grouping conditions of all centers are visually displayed in a bar chart mode;
the 'project dynamic' records the operation of each central operator on the grouping state and the visiting state of patients or subjects.
The information checking module is used for providing a real-time mandatory item checking function;
the password setting module is used for setting and changing the current login password;
and the item switching module is used for switching among the items when the user participates in a plurality of items simultaneously.
In a second aspect, embodiments of the present invention provide a big data processing method for new drug clinical evaluation research, including a step of processing big data of new drug clinical evaluation research by using the big data processing system for new drug clinical evaluation research as described in any one of the above.
It can be understood that the big data processing method for clinical evaluation research of new drugs provided by the present invention corresponds to the big data processing system for clinical evaluation research of new drugs provided by the present invention, and the explanation, examples, beneficial effects and other parts of the relevant contents can refer to the corresponding parts in the big data processing system for clinical evaluation research of new drugs, which are not described herein again.
In summary, compared with the prior art, the method has the following beneficial effects:
the big data processing system for the clinical evaluation research of the new drug provided by the embodiment of the invention comprises: the item selection module is used for displaying and determining the current item; the data display module is used for displaying relevant data information of the current project book center; a subject correlation module for user management of subject information; and the information processed by the item selection module, the data presentation module and the subject correlation module has an association relation in the database. Data of a plurality of centers are integrated on the system, so that the workload of connecting each heterogeneous application system is reduced, the coupling degree between heterogeneous systems is reduced, the flexibility and the response speed of the system are improved, the data management is facilitated, and the reliability of clinical pharmacological test results is improved.
It should be noted that, in this document, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.
The above examples are only intended to illustrate the technical solution of the present invention, but not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and such modifications or substitutions do not depart from the spirit and scope of the corresponding technical solutions of the embodiments of the present invention.
Claims (8)
1. A big data processing system for clinical evaluation studies of new drugs, comprising:
the item selection module is used for displaying and determining the current item;
the data display module is used for displaying relevant data information of the current project book center;
a subject correlation module for user management of subject information;
the information processed by the item selection module, the data display module and the subject correlation module has an incidence relation in the database.
2. The big data processing system for new drug clinical evaluation research as claimed in claim 1, wherein the relevant data information displayed by the data display module includes research units and subject enrollment and subject status.
3. The big data processing system for new drug clinical evaluation studies as claimed in claim 1, wherein the subject-related module comprises a subject screening module and a subject management module;
the subject screening module is used for inputting the added patient information, checking the added patient into a group and quickly searching the appointed patient;
the subject management module is used for viewing the information of the grouped subjects, adding visits for the subjects, crf entering and saving, rapidly searching the subjects and dropping the subjects.
4. The big data processing system for new drug clinical evaluation research as claimed in claim 1, wherein the big data processing system further comprises:
and the user management module is used for distributing an account and a password for the user.
5. The big data processing system for new drug clinical evaluation research as in claim 4, wherein the big data processing system further comprises:
and the log module is used for recording login information generated under the current user account and recording system operation information of the current user account.
6. The big data processing system for new drug clinical evaluation research as in claim 5, wherein the big data processing system further comprises:
and the progress monitoring module is used for providing a real-time data overview function of the progress of each center, a real-time display function of the group entering progress of each center and a display function of the operation record of each center.
7. The big data processing system for new drug clinical evaluation research as claimed in claim 1, wherein the big data processing system further comprises:
the information checking module is used for providing a real-time mandatory item checking function; and/or
The password setting module is used for setting and changing the current login password; and/or
And the item switching module is used for switching among the items when the user participates in a plurality of items simultaneously.
8. A big data processing method for new drug clinical evaluation research, characterized by comprising a step of processing big data for new drug clinical evaluation research using the big data processing system for new drug clinical evaluation research of any one of claims 1 to 7.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113314192A (en) * | 2021-06-17 | 2021-08-27 | 医渡云（北京）技术有限公司 | Clinical trial data processing system, method, device and storage medium |
| CN113593664A (en) * | 2021-07-30 | 2021-11-02 | 嘉兴易迪希计算机技术有限公司 | Data entry method based on electronic log in EDC system and EDC system thereof |
| CN114155922A (en) * | 2021-12-14 | 2022-03-08 | 浙江太美医疗科技股份有限公司 | Data display method, processing method, device, computer equipment and storage medium |
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| US20170308680A1 (en) * | 2015-03-03 | 2017-10-26 | Mitchell D. Efros | Method for creating and using registry of clinical trial participants |
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| US20170308680A1 (en) * | 2015-03-03 | 2017-10-26 | Mitchell D. Efros | Method for creating and using registry of clinical trial participants |
| CN107247864A (en) * | 2017-04-18 | 2017-10-13 | 上海交通大学附属第六人民医院 | Clinical drug trials and subject's management system and method |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN113314192A (en) * | 2021-06-17 | 2021-08-27 | 医渡云（北京）技术有限公司 | Clinical trial data processing system, method, device and storage medium |
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| CN114155922A (en) * | 2021-12-14 | 2022-03-08 | 浙江太美医疗科技股份有限公司 | Data display method, processing method, device, computer equipment and storage medium |
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