System Validation Reports Filed to TMF
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During a recent client facility audit it was raised whether we as a CRO provide to the study TMF the validation documents of the in-house eTMF. Per the EMA Guideline on GCP compliance in related to TMF from 2017, "documentation to demonstrate validation of trial-specific builds of computer systems (e.g. e-CRF and IRT)." is considered to be essential. So this applies then to eTMF as well then I assume… and then it is part of study TMF. This looks odd. I would really consider the validation to be inspected/audited rather in-house, as separate documents and not as part of the TMF. Can we interpret "sponsor file" of the TMF maybe not as 1 location only (where we send the eTMF files at the end)? But rather something that means that certain documents are present with client, and set of others present with CRO after trial is closed? I mean requirements for "sponsor" in GCP means the CRO when the duty is delegated. So why sponsor file cannot mean files at the CRO with the same logic? Or it is indeed expected that we place a copy of the validation docs all the time to each study TMF?
I raised these in the GCP forum earlier and was advised to reach out for opinion from Computing as well. Thank you for any input!
Matthew Jones - Chair DIGIT Committee
The EMA guidance in relation to TMF (Paper and Electronic) is unfortunately still in draft and many of us had provided comments as such that it is ambiguous as to where the validation documentation resides.
In a recent EMA IWG I attended we discussed where validation documentation should be for eSource systems as a whole, and as long as there is adequate linkages back to the validation documentation for the exact version of the eTMF in place they stated that was sufficient. However, if I understand correctly, in your case if you choose to retain the validation documentation on behalf of the sponsor and provide in the event of an inspection,this should also be documented in contractual agreements defining what documentation, the timings of it's provision and even when the contract is complete how those documents can be accessed during an inspection. Business continuity plans in case of disaster/ insolvency etc, also need to be considered.
The inspectors during the meeting discussed with us how its very difficult for them to have direct access to this information, and they consider that if a CRO retains these, that it still comes under the essential documents required for study reconstruction, and therefore, must be treated as such.
I hope this helps a little, and please let us know if you have further questions
Thank you Matthew, for the prompt feedback! I was maybe not precise enough with the wording, apologies. So it was the validation documentation of our in-house eTMF system that was requested by client to be filed into the study TMF.
I agree that the validation documents are essential for the trial, and also that these shall be available for inspection.
I also agree with your point on the business continuity. that the access to the validation documentation need to be ensured, no matter what might happen with the company in the future.
Your feedback actually supports my first idea for resolving this issue. My thinking was that I would not like to suggest the filing of the validation documents to study TMF. We would rather:
a. make it clear in the study TMF where the validation documents of the appropriate version(s) of the eTMF used in the trial reside (in house with CRO);
b. ensure through our business continuity plan the access to these documents for clients/inspectors in the future.
In this way it is clear where the records are, and ensured that are accessible in the future.
Did I get anything wrong?
Matthew Jones - Chair DIGIT Committee
That's the course of action I'd recommend to any of my clients, so I think you're perfectly on point.
If you had to provide that volume of information to every TMF, it would become very unwieldy very quickly, and I would seriously doubt that's what the inspectors would want.
Glad I could help