10/11 October 2023
In April, the EMA published a notice for clinical trial sponsors to highlight the requirements for the qualification and validation of computerized systems used for managing clinical trial data. The agency has also updated questions 8 and 9 on their Good clinical practice (GCP) Q&A page, which provide further related guidance on computerized systems. In July, the EMA added a new Q&A 13 on the requirements for Principal Investigator (PI) review and sign-off of data.
The Investigator is responsible for data entries into eCRFs and other electronic records under their supervision. Those data should be reviewed and signed-off. The signature of the PI (or authorized member of the investigator’s staff) is considered "as the documented confirmation that the data entered in the eCRF and submitted to the sponsor are attributable, legible, original, accurate, and complete and contemporaneous", the EMA says.
The sponsor defines and justifies the acceptable timing and frequency for the sign-off needs for each trial on a risk-based manner. It will not be sufficient to just implement one signature immediately prior to database lock.
The PI should review the data on an ongoing basis in order to detect shortcomings and deficiencies in the trial conduct at an early stage. This is a precondition to undertake appropriate corrective and preventive actions (CAPAs). Appropriate PI oversight is required to ensure that incorrect data is being corrected in a timely manner and to implement the CAPAs at the investigator site. PI oversight is a general requirement to ensure clinical trial participant safety and data integrity. "Oversight can be demonstrated via various means, one of them being review of reported data", the agency says.
More information can be found on EMA´s GCP website.