Home Forums General Discussion Forum ICH E8 8.3.3 Sponsor eTMF Requirement for IRB Approvals for Revisions

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      Sally Quinn

      In 8.3.3 (ICH E8 R2), it does seem pretty definite that the sponsor must include IRB approvals for any revisions to protocol, ICF, other written material to the subject and ads in their eTMF. There is no “where required” as there is for the Continuing review of trial. Is a note added to the TMF index stating that only initial and final approvals will be uploaded to sponsor eTMF because any interim ones are captured via monitoring report sufficient or must these approvals be in the sponsor eTMF?

      Thank you.


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