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Thread: Filing documents that are 'drafts and tracked' changes

  1. #1

    Filing documents that are 'drafts and tracked' changes

    In our current eTMFs we also file documents that are the 'drafts and tracked changes' before a document becomes final, e.g CRFs, Protocol, PILs, CFs and others.

    I understand that it is important to show that there has been a robust process in place during the drafting and review of the documents in question, but I cannot find anything officially that tells us that we must save these in our TMFs. In the past I have worked with ISO auditors and they were adamant that these documents also form part of the history of the trial and serve as important decision-making documents. Other auditors were not of the same opinion.

    Does anyone have any advice as to what is considered good working practice in this area? any experience with the MHRA having commented on this during an inspection?

    Thanks

    Joanna

  2. #2
    Forum Member
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    Jan 2012
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    8
    Hi Joanna

    I always keep a 'track changes' version as part of the audit trail, but more so that it's easy to see what changes have been made than to necessarily indicate exactly who suggested changing what. I tend to take the view that once a new protocol is agreed, everyone signs up to it and so it's largely irrelevant who proposed what at the discussion stage - but it's very important to be able to look back and see what text was changed without having to sit and cross check the two finalised 'changes accepted' version.

    I also only ever keep a single copy between versions - the original approved version, the new one in tracked changes, and the new one with changes accepted. I don't see the point of keeping every step along the way when Bill, Bob and Ben added their thoughts - just the version initially submitted and the changes from there that are formally amended. Otherwise you end up with so much paperwork it actually makes the whole picture less clear and it's impossible to see within the files what the important steps were.

    Hope that makes sense.
    CTU

  3. #3
    From my experience, there are two issues here: (a) retention of evidence of a regulated process; and (b) retention of draft documents.

    On the first point, if you have a document process that requires certain documents to go through a formal review and approval process, it is not uncommon for regulatory inspectors to request evidence that the documented process has been followed. One way - and not necessarily the best - of achieving this is to retain draft documents with tracked changes. These provide evidence that the final document in the TMF had been reviewed and commented upon, as per your SOPs. However, there are other ways of maintaining such evidence, the most commonly used one being the use of a document review form - or an electronic workflow equivalent. A document review form captures the review process but does not oblige you to retain previous draft versions. I am not aware of any scenarios where regulatory inspectors or legal counsel have required draft documents associated with a document review form (assuming there is a policy in place stating that drafts are routinely destroyed!). This is the preferred approach.

    On the second point, most experts would NOT advocate the retention of draft documents for any significant period of time following the finalisation and approval of a final document. Draft documents have the potential to open up a legal can of worms! Draft documents are not approved documents and therefore their content has little relevance following approval of the final document. In addition, there is often no duty or obligation for an author to accept comments made by reviewers. You therefore have the potential for a legal dispute if reviewers made comments that were subsequently not accepted. An organisation should be audited/inspected on final documents that contain management-approved content and not on draft documents and refviewer comments that are unapproved.

    In terms of an eTMF, many companies use a single technology platform for the creation and development of TMF content and for management of final, approved TMF content. However, the security permissions define the Trial Master File as only constituting those documents which have been approved. When a regulatory inspector, for example, logs on to the eTMF for inspection purposes, he/she would only have access to final, approved TMNF documents. Documents not yet approved are not considered to be TMF. Draft documents are automatically soft-deleted following approval of the final version.

  4. #4
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    Join Date
    Sep 2014
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    Draft copies in TMF

    So what is the conclusion on this ?

    I have 20 track changed version controlled draft documents. Should I be keeping all such version controlled draft documents every time there has been a change or just keep one draft and keep saving on top with track changes ? Should all draft copies be kept in the TMF or just the final version ?

    Quote Originally Posted by rammellconsult View Post
    From my experience, there are two issues here: (a) retention of evidence of a regulated process; and (b) retention of draft documents.

    On the first point, if you have a document process that requires certain documents to go through a formal review and approval process, it is not uncommon for regulatory inspectors to request evidence that the documented process has been followed. One way - and not necessarily the best - of achieving this is to retain draft documents with tracked changes. These provide evidence that the final document in the TMF had been reviewed and commented upon, as per your SOPs. However, there are other ways of maintaining such evidence, the most commonly used one being the use of a document review form - or an electronic workflow equivalent. A document review form captures the review process but does not oblige you to retain previous draft versions. I am not aware of any scenarios where regulatory inspectors or legal counsel have required draft documents associated with a document review form (assuming there is a policy in place stating that drafts are routinely destroyed!). This is the preferred approach.

    On the second point, most experts would NOT advocate the retention of draft documents for any significant period of time following the finalisation and approval of a final document. Draft documents have the potential to open up a legal can of worms! Draft documents are not approved documents and therefore their content has little relevance following approval of the final document. In addition, there is often no duty or obligation for an author to accept comments made by reviewers. You therefore have the potential for a legal dispute if reviewers made comments that were subsequently not accepted. An organisation should be audited/inspected on final documents that contain management-approved content and not on draft documents and refviewer comments that are unapproved.

    In terms of an eTMF, many companies use a single technology platform for the creation and development of TMF content and for management of final, approved TMF content. However, the security permissions define the Trial Master File as only constituting those documents which have been approved. When a regulatory inspector, for example, logs on to the eTMF for inspection purposes, he/she would only have access to final, approved TMNF documents. Documents not yet approved are not considered to be TMF. Draft documents are automatically soft-deleted following approval of the final version.

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