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Question: ArrayHow to ensure the accuracy and compliance of data during data transmission and integration into databases? How to protect privacy and remain blind
Answer: The compliance and accuracy in the data management process of Non CRF (Non Case Report Form) can be roughly ensured from the following aspects: 1 Sign a data transmission protocol. Specify the media, method, content, and time point for data transmission in the protocol, clarify which information is collected and which information is not collected (to protect the privacy of the subjects), clarify the recipient of data transmission (to ensure blind state), and conduct corresponding tests before formal data transmission. During the data transmission process, the sponsor and CRO/laboratory should use validated computer systems to ensure compliance. If using email for transmission, it must be encrypted and protected. Passwords cannot be sent within the same email as files. It is not recommended to use open network transmission, and closed networks such as VPN can be used. 3. After receiving data, it is necessary to ensure the security of data storage. If possible, data should be uploaded to the Clinical Data Management (CDM) Database, or read-only permissions should be set on the server where the data is saved to prevent data from being tampered with. The process of uploading non CRF data to the Clinical Data Management (CDM) Database needs to be pre configured and validated/tested. Programmers need to identify the content of data files and ensure that the upload method does not cause errors or omissions in the data. 5. Data cleaning for non CRF data. The initial cleaning of data is usually carried out at the source of CRO/laboratory to ensure the correct transcription of data and the correct correlation between data, samples, subject IDs, and visits. The data administrator of the applicant needs to ensure the integrity and accuracy of the data during the data cleaning process. 6. Finally, the study cannot be locked out until all Non CRF data is processed and verified.