Should Drafts be Retained in the TMF?

Based on responses from members of the TMF Reference Model project team, this question has now been included in our Frequently Asked Questions page. A summary is also provided below:

Question: Should draft documents be filed in the Trial Master File?
Unanimous opinion across the TMF Reference Model is that draft versions of documents should not be kept in the TMF, including prior versions with tracked changes.

Key reasons include:

  • Maintaining drafts and annotations can highlight issues that don’t exist such as comments not followed up or opinions not agreed with;
  • There is no obligation to action all comments on a draft version;
  • European Directive 2003/63/EC contains the requirement to retain “all written opinions on the protocol and procedures”, but not drafts;
  • Documentation / correspondence should demonstrate that the review process has been followed; and
  • Retention policy may dictate that drafts are destroyed.

Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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