Rammell Consulting Limited

When is a CSR a TMF?

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It appears that the anxiety within the industry regarding the proposed Trial Master File retention requirements in the draft EU Clinical Trial Regulation may be unfounded. Earlier today I had the pleasure of meeting Mrs. Marina Yannakoudakis MEP at her constituency office in London, together with 2 colleagues from the GCP Records Managers Association (GCP-RMA). We discussed industry concerns regarding the wording of Amendment 222 and Amendment 223 and it appears that the intention may have been for these 2 clauses to refer to retention of the clinical study report and not to the entire TMF. In any event, it was somewhat of a surprise to the MEP that the TMF was as complex and extensive as it is and therefore the requirement to retain this entire document set in electronic format and for an indefinite period does not appear to be justified. Replacing “trial master files” with “clinical study report” in these 2 amendments also makes the text consistent with other clauses and articles within the draft Regulation.

This would however leave the retention period for the TMF itself undefined and so our recommendation was for this to be retained for “a minimum of 5 years” to be consistent with the original wording of the draft Regulation and consistency with existing national legislation.

Our thanks were expressed to Mrs. Yannakoudakis who agreed to provide an update to the Rapporteur for the Regulation, Mrs. Glenis Willmott. We hope that these comments are taken on board as the draft Regulation proceeds to the next stage in Parliament.

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