Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:
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1 Data management
For the specific requirements of data management, please refer to the "Data Management Plan", this plan only covers the general requirements of data management.
1.1 eCRF establishment
In this experiment, an electronic data management system was used to collect and manage the experimental data, and the data management system was developed and maintained by MyMaster (Beijing) Information Technology Co., Ltd.
Before designing an eCRF, an annotated CRF and an eCRF design description should be formulated first. Annotated CRF should indicate the variable name in the corresponding data column of the CRF. The data variable naming should conform to the current requirements of CFDA, and to meet the requirements of CDISC as much as possible. In addition, the annotated CRF/eCRF design description should at least include the data set to which the variable belongs, variable name and label, variable type, variable format and length, and variable assignment range.
The eCRF design is performed according to the established Annotated CRF and eCRF Design Specifications. The database system has the function of checking the operation and modification records, and strictly implements the relevant SOP of the data management unit. Develop data entry instructions and require data entry and correction personnel to ensure accurate and complete entry according to the entry instructions.
EDC is released for use after passing the test and being approved by the sponsor or the sponsor's authorizer; the PI, Sub-I, CRC, PM, CRA, DM, etc. of each role's authorized personnel can be officially launched and applied after training.
1.2 Data collection and entry
The data collected in the source files will be recorded in the study medical records in a timely, complete, correct and clear manner by the investigators of each center, and then directly entered into the eCRF of this study by the investigators or authorized data entry personnel. Investigators at each center should ensure the accuracy, completeness, and timeliness of data submitted to the eCRF.
A supervisor (CRA) monitors the conduct of the trial for adherence to the trial protocol. Verify that all study medical records are filled out correctly and consistent with the original data. If there are any errors or omissions, the researchers should be promptly requested to correct them. The original records should be kept clear and visible during revisions, and the corrections should be signed and dated by the researcher.
There should be special records for the transmission of completed research medical records among investigators, supervisors, and data entry personnel, and corresponding signatures should be given upon receipt, and the records should be properly kept.
Data entry personnel enter data using one-time entry. If problems or unexpected situations are found in the input process, they should be registered and reported in time so that the problems can be dealt with quickly. After data entry, a 100% source data verification (SDV) was performed by the monitor.
1.3 Data review and challenge handling
The inspector is responsible for the on-site inspection of the center, and 100% checks whether the eCRF entry is correct and complete, and whether it is consistent with the original documents such as the original medical record and laboratory inspection report.
The data management personnel conduct challenge management on the trial data according to the data verification plan (DVP).
When data is entered into the EDC system, if there is illogical data, the system will automatically check and ask questions (Query); these queries need to be reviewed and answered by researchers or authorized personnel.
In addition to the automatic verification of the system, questions that are manually verified by SAS programming or data administrators can be manually added to the EDC system when the researcher needs to clarify/verify/confirm.
Researchers need to answer questions in a timely manner. Data administrators, supervisors, and medical staff will reply to questions, and if necessary, they can issue questions again until the data is "clean."
1.4 Investigator Signature
The data administrator needs to confirm that all queries are cleaned up, and the researcher conducts an electronic signature review for confirmation. If there is any data revision after signing, it needs to be re-signed.
1.5 Medical Coding
Medical coders perform medical coding jobs. The coding content includes concomitant medications and adverse events. Adverse events will be coded according to the MedDRA (version 17.0 or above) dictionary, and concomitant medications will be coded using the WHO ATC.
During the coding process, if any medical term cannot be coded due to inappropriate, inaccurate, or vague provision of medical terms, the DM can challenge the researcher online in real time.
Before the database was locked, the researchers reviewed the medical codes.
1.6 Data Lock and Export
Complete the data lock library list, according to the database lock procedure, the data management personnel, statistical analysts, clinical monitor representatives, researcher representatives, etc. sign and approve the database lock file in writing, and the data administrator will export it to the database in the specified format. Submit it to the statistician for statistical analysis, and the locked data cannot be edited. After the data is locked, if there is definite evidence that it is necessary to unlock the data, the researchers and relevant personnel need to sign the unlocking document.
1.7 eCRF Archive
At the end of the trial, the eCRF of each subject is exported to PDF for electronic archiving, and the CD-ROM is stored in the clinical trial unit for at least 5 years after the completion of the trial.
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