Urgent Request-Data Extract Report-Time information on Entered Date & Last Changed Date

User_88U4E

Dear support

I am writing to formally request the inclusion of detailed time information (hours and minutes) for both "Entered Date" and "Last Changed Date" in the Clinical One Data Extract Report.

​Key Rationale for This Request:​

1. Data Traceability & Regulatory Compliance​

Detailed timestamp (date + time) is critical for verifying when data was initially entered or updated, which is a core requirement for ensuring data integrity in clinical research . As mandated by regulatory guidelines (e.g., FDA 21 CFR Part 11), audit trails and data extracts must support full traceability of data lifecycle events . Currently, without time details, we cannot accurately reconstruct the sequence of data changes or validate data entry timelines.​

2. Industry Standard Practice​

Including complete datetime stamps in datasets is a universal feature across most EDC/CDMS platforms . This alignment with industry norms ensures consistency for users transitioning between EDC systems.​

3. Practical Limitations of Audit Trail Dependency​

While Clinical One already stores detailed time information in the audit trail , the audit trail dataset is excessively large and unoptimized for routine data analysis . Extracting time-related insights directly from the audit trail is inefficient, time-consuming, and prone to errors—defeating the purpose of having a streamlined Data Extract Report.