Contemporaneous Timeline Question

[Amanda Perlman]

Hi everyone,

I am curious as to everyone’s understanding of the standard contemporaneous timeline. I believe the industry standard is 30 days. Is this 30 days from document finalization or receipt to eTMF upload, or 30 days from document finalization or receipt to full eTMF approval?

[Kathie Clark]

30 days is common in industry but of course there is no real standard. There are real differences of opinion on how to measure this. Receipt to finalization date is common but some people use document date to finalization date. The former can be “gamed” by a user and the latter does not work well with documents that are not prepared for the specific trial (imagine a CV that was finalized a year ago but just uploaded).

The HAs are largely silent on this except to say:
Documentation in the TMF that is relied upon for subsequent activities should therefore be in the TMF before these activities take place; for example, monitoring visits rely on the information in the previous report, so the previous report should be completed and filed in the TMF prior to the next visit.

— MHRA GCP

I did a presentation on this at the TMF Summit, if you want to reach out to me on LinkedIn I can send you a copy.

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