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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：
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1. Electronic data management
1.1 Data management of this experiment is based on the electronic data management system
1.2 Construction of electronic Case Report Form (eCRF)
The data manager builds eCRF based on the study protocol and case report form.
1.3 Permission Assignment
EDC system users to take the form of hierarchical empowerment, system administrators to confirm the identity of the data managers, data managers confirm the arbitrator, inspector, the sponsor, the identity of the principal investigator agencies, institutions mainly the researchers confirmed that the unit researchers, data operator, the identity of the ethics committee members, hiberarchy, your account was created with different permissions to access the EDC system.
1.4 Data entry
Data entry Timely and accurately enter eCRF data into the case report form.The eCRF is not regarded as the original record, and its content is derived from the "case Report Form".
1.5 Source data On-site Verification (SDV)
Arbitrator in the center of the research site login data monitoring data management system of data, 100% of the check electronic CRF form data and cases such as the source data consistency, found that the problem may at any time online question, download data operator question, the researchers offer solutions, data operator directly update the data in question management interface.If necessary, the supervisor may repeat the question.
1.6 Data locking and export
All subjects have completed the test, and the case report form has been input into the system and reviewed by the supervisor. After the data manager's review is correct, the data manager will lock the data.After all the data are locked, the data manager will import them into the specified database and submit them to statisticians for statistical analysis.
2. Develop a data management plan
2.1 The data management plan is written by the data manager.
2.2 The data management plan will serve as a guiding document for the entire data management process, and thereafter all processes shall operate according to the time and method defined therein.
2.3 The contents of the data management plan include
2.3.1 Management of data management plan, such as ownership, cover provisions, catalogues, etc.;
2.3.2 General conditions of the study, such as the purpose of the study and the overall design of the study;
2.3.3 Schedule of data management.The timing of commencement and completion of each segment should be reflected in this schedule, which should be coordinated with the overall clinical trial schedule;
2.3.4 Responsibilities of relevant personnel, including EDC system administrator (Admin), project data Administrator (DM), researchers (Ivammonator), data log-in workers, monitor (CRA), etc.;
2.3.5 Data management design, including database design and logic check design;
2.3.6 Allocation of users and permissions;
2.3.7 Provisions on data processing;
2.3.8 Data quality control;
2.3.9 Database closure;
2.3.10 Data security and confidentiality measures;
2.3.11 Emergency plan of EDC system.
3. Data management design
3.1 Design data Collection Form (Case Report Form)
According to the test scheme design data collection form, and by the study team members, including the main researchers, arbitrator, data managers, a statistician and fill in the (CRC), from a different perspective to review of data acquisition and its associated files, make it meet the needs of different members, enhance its availability, improve the quality of data, reduce the data cleaning program later.
3.2 Electronic Case Report Form (eCRF)
According to the clinical study protocol and case report form, it is designed in the EDC data management system and completed by the data manager who has received the EDC system application training.
3.3 Design logic check, including automatic system logic check and manual logic check.
3.4 System test of the project
Test the built eCRF to ensure that all CRFS in the project can be entered, saved, displayed and exported, the double-entry inconsistency checker runs normally, all logic checks can run normally, and all questions can be correctly released, downloaded, updated and reviewed.
3.5 Role and permission assignment
3.5.1 Only create accounts for relevant personnel who have received EDC system training;
3.5.2 The account of each research institution can only access the subjects of the institution. If necessary, specific roles (such as the principal investigator) shall be given to share the subject function, so as to timely understand the subjects of each research center;
3.5.3 The accounts created are classified into various roles, and each role has its own specific permissions.The following are the permissions of various roles to operate on the EDC system:
1) Main investigator: check the electronic CRF (hypertext format, operation traces can be checked) of the cases of the institution, check the progress of the whole study and the institution, and understand the adverse events and combined medication of the whole study and the institution;
2) Investigator: To inquire the case data, relevant questions and solutions of my observation, and to understand the adverse events and combined medication of the whole study and the institution;
3) Data entry clerk: data entry, download questions, update data, and consult the electronic CRF of the institution's medical cases (hypertext format, operation traces can be seen);
4) Inspectors: maintain the normal value of physical and chemical examination in each center, check the electronic CRF of all cases studied (hypertext format, operation traces can be seen), ask questions, review data, check the adverse events and combined drug use, and check the research progress of the whole study and various institutions;
5) Data manager: Design logic verification, build eCRF, check the electronic CRF (hypertext format, visible operation traces) of all cases in the study, question raising, data review, data locking and data export;
6) Sponsor: check the electronic CRF of all study cases, check the operation traces, check the adverse events and combined medication, check the whole study and the progress of each institution;
7) Ethics committee: check the electronic CRF of all cases studied, check the operation traces, check the adverse events and combined medication, and check the whole study and the research progress of each institution.
4. Data entry and verification of EDC system
4.1 Data entry personnel must undergo relevant training before operation;
4.2 Enter the system after inputting user name, password and additional password;
4.3 The EDC system account and password are confidential and shall follow the relevant confidentiality regulations;
4.4 The data entry clerk is responsible for reporting the research data according to the follow-up points, so as to facilitate the monitor and data manager to synchronously review the data in a timely manner and to have questions about the suspicious data, so as to get a timely and correct reply to the questioned data;
4.5 After data entry, the data entry clerk can click "Save" to save the entered data, and click "Submit" after confirming that the current page entry is complete and no modification is required.After submission, the editing permission of the page is cancelled. If you need to supplement or modify the data, you can contact the data administrator and apply through the network message. The latter has the right to open the editing permission of the page requiring supplement or modify the data through question solving.Use the online method to confirm the double inconsistencies.
4.6 After the data entry clerk submits the data, the system will conduct logical check on the input data, manual check with CRA, and on-site source data verification (SDV). When problems are found, questions will be released. The data clerk will log into the system regularly, download the questions of the institution, and generate data clarification table (DCF).
4.7 The researcher/keylogger answers the questions in the query table, and the data is only modified on DCF, which is saved as the source file, and the keylogger updates the data online in the system.
4.8 After the examiner replies to the questions, the contents of the questions shall be confirmed by the examiner. After the confirmation, the questions shall be reviewed and approved.
4.9 The data manager shall check the questions in the test to confirm whether all the questions have been solved.
4.10 The inspector visits the research institutions regularly, logs in the EDC system, and verifies the consistency between the electronic CRF data and the case report form and other source data by 100%.
5. Database closing and locking
5.1 notice, by the clinical researchers and cooperates each blindly data subjects have all keyed to the EDC system and dealt with, including adverse events track inspection data, all questions have been solved and updates to the database, code directory for completeness and consistency has audit, data managers have to blind state audit data, blind state audit report has been all after the signing of the relevant personnel, data managers apply for shutdown, once approved, cancel the database edit permissions, record database locking point in time, as evidence of edit permissions were canceled.
5.2 The data manager will export all the test data to the database file and submit it to the statistician for statistical analysis.
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