ICH E8 8.3.3 “Where Required” Meaning

[Sally Quinn]

Hello,
In ICH E8, 8.3.3’s last bullet “Continuing review of trial (where required) and also in 8.3.19 under Location of Files for sponsor “X (where required). What does “where required” mean? There is some debate between our CRAs as to whether the site’s IRB Progress reports have to uploaded into the sponsor eTMF or if a note in the TMF index stating that they do not have to be in the sponsor eTMF because they are captured via monitoring reports is sufficient. The meaning of the “where required” might help solve this debate. What are your thoughts?

Thank you.

Sally

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