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 versions with track 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.

Individual comments from Reference Model Team members:

“Most sensible SOPs on controlled documents would provide for the retention only of approved versions of documents and the discarding of drafts. It may also, depending on the document review and approval process, be necessary to keep sufficient documentation / correspondence to demonstrate that processes have been followed per SOP.”

“Drafts and annotations should be deleted upon promotion to approval.”

“From a potential litigation perspective, it can be extremely dangerous to retain draft documents following completion/approval of the final document. If there is a regulatory need – as sometimes there is – to maintain an audit trail to demonstrate that a document was properly reviewed as per an SOP, other means should be used to enable such an audit trail to be retained. For example, many sponsors maintain some kind of document review form (or electronic equivalent). This form contains signatures of reviewers and the version of document reviewed but does not contain their review comments. A sponsor has no obligation to either accept review comments or to respond to review comments. It is usually sufficient simply to demonstrate that a proper review was conducted and the final document was approved by a duly authorised individual.”

“Many sponsors include in their corporate retention policy a requirement to destroy drafts; retention would therefore be non-compliance with company policy.”

“There may be only one exception, namely protocols. European Directive 2003/63/EC contains the requirement to retain “all written opinions on the protocol and procedures”. However, even this does not suggest keeping drafts, merely any “written comments” on the protocol. Furthermore, the requirement to retain “all written opinions” could be interpreted to apply only to the final protocol and approved procedures, rather than to draft documents.”

“Some systems actually delete all draft version a specified number of days (e.g. 30 days) after the document is approved. Part of the discussion for that decision was performance concerns if having to maintain minor versions. Also it was augmented that only things relevant enough to actually be approved should be retained in the system.”

“Draft documents are not filed in the trial master file unless they report important decisions or new information about the trial. For example, the study team would file the Core ICF, Country-specific ICF or Site-specific ICF “Tracked Changes” documents if revised due to a protocol amendment.”

“Drafts should be administrative, and should be filed as such.  They can be kept in other storage locations and used for development reference.  No-one audits to drafts.”

“If a health authority is inspecting to Track Changes versions, then there is a bigger problem than just what is in the files.”

“Only the final document should be in the TMF. Drafts documents are working documents and if retained, should only be keep until the study is finished. They would only be archived if that is the company policy.”

June, 2015

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Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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