Managing Data and Documents at the Investigational Site

EMA recently published their 2020 GCP Inspectors Working Group Report, and it’s always interesting to see what the findings have been, even if we’re a couple of years on from the inspections reported.


This iteration of their annual report makes interesting reading as always and I was not really surprised that the top area for findings was Trial Management by the Sponsor, and within that category Data and Document Management have the most findings. The surprise for me was that when you read the detail the focus seems to be on oversight of CRFs and Documents at the investigational Sites. Some of their example findings are listed below:


Data Management:

• audit trails of the archival CRFs in pdf format incomplete or ambiguous;

• error in time settings of the eCRFs leading to incorrect reports of SAEs;

• eCRF completion guidelines finalised after the first subject enrolment.

Document Control:

• Shortcomings in the content and organisation of the Investigator Site File;

• No defined review process for the Investigator Site File;

• Discrepancy in information provided regarding the use of electronic medical records and the reporting thereof.


So what can we learn from this? Oversight of data management must start with control of the Case Report Forms and when electronic CRFs are involved this is even more critical. We must make sure that site staff are equipped with the completion guidelines in good time, before they need to start entering data. Basic functionality such as time settings is vital to making sure the data can be managed correctly, and particularly critical data such as safety reports.


These are obvious points from the items above, but more difficult to address are the issues of the CRF audit trail, having independent copies for the investigators and the full story of the data being clearly told. The Regulators would ideally like investigators to have their own, independent copies of the CRFs throughout the trial, but this is difficult to achieve with centralised eCRFs. Because of this the audit trail MUST be clear and unambiguous so that the sponsor cannot be accused of changing data independently of the investigator. How this happens is up to the sponsor in collaboration with the Electronic Data Capture vendor, but it must be addressed.


With regard to the Document Control findings I will just say this: The Investigator Site File (ISF) is part of the Trial Master File and must be considered and managed as such. The file set up needs an index with placeholders and filing conventions and the monitoring plan must include regular review of the ISF along with the relevant actions to ensure completeness. This can be a challenge if the plan relies heavily on remote or centralised monitoring, but it must be taken into consideration.


The point about electronic medical records is a reflection of the move in many institutions to use of eHRs, and again our site set up and monitoring must take these complexities into

account. In additions all reports and records of data sources and review must be clear, complete and accurate.

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