UK Government Seeks to Prevent Proposed Amendment to Clinical Trial Regulation

If you’ve been following the ongoing debate regarding the proposed European Clinical Trial Regulation (see previous posts on this site), you will know that the text currently before Parliament is proposing (a) that Trial Master File content be held and maintained only in electronic form and (b) is retained for an indefinite period. I have corresponded with the UK Government on this issue and the initial responses are promising.

The Rt Hon the Earl Howe, Parliamentary Under Secretary of State for Quality confirms that he is concerned with these amendments and that the requirement to hold the TMF in electronic format and to be retained indefinitely “would impose a disproportionate burden on researchers”.

The amendments will be examined during negotiations between the European Council of Ministers and the European Parliament, and the Government “will try to prevent this amendment from being in the Regulation”. Departmental officials have already discussed a number of amendments that impose unnecessary burdens, including this amendment, with MEPs, including the lead MEP for the Regulation. Officials are also in contact with the Presidency of the Council (currently Lithuania) and other member states about these amendments.

Action plan: If you are an EU citizen and are concerned about the potential imposition of an obligation to maintain all trial master file records in electronic format for an indefinite period, please write to your MP and to your MEP, making reference to Amendment 223, Article 55, Paragraph 1. MPs, MEPs and Ministers need to hear a consistent message on this topic.


About rammellel

Records management consultant to the life sciences / pharmaceutical industry
This entry was posted in Compliance, Regulations, TMF. Bookmark the permalink.

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