TMF actions for publications

Hi

I am keen to know what other CTU’s include in their TMFs around publications. Do you only include the initial protocol and main publications or all linked publications? What associated documents do you require in your TMF for these publications?

Thanks, Susie Hennings Keele CTU

Hi Susie,

Hope all is well with you. We would keep all outputs in the TMF including Clinical Study Report, Abstracts, Publications, Presentations.

In terms of accompanying docs we would keep the declarations from authors, signed review/approval forms.

Cheers
Scott, WCTU

[Author]

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