Good Clinical Practice Guide
Results 1 to 2 of 2

Thread: Filing of all drafts of documents before filing

  1. #1

    Filing of all drafts of documents before filing

    We would like guidance as to how necessary it is to save all the drafts whilst a document is in development, as part of the TMF. It is understandable that critical documents like the protocol are developed and reviewed robustly and a trail is saved as evidence of such review. I have come across auditors who say that it is really important to save drafts in the TMF and other auditors who say you only ever need to save the final versions.

    We would be grateful for any advice that would make our TMFs neater.



  2. #2
    Please refer to the thread "Filing documents that are 'drafts and tracked' changes " in the TMF section.

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts