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?
Answer:
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.