Filing of all drafts of documents before filing

[Joanna Black]

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.

thanks

Joanna

[MHRA Moderator]

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