v3 Query: IRB/IEC Artifacts

Question: It appears that “acknowledgement of receipt” is now specifically noted as a sub-artifact under IRB or IEC Submission, while “documentation received from the IRB/IEC in response to submission indicating acknowledgement” remains within the definition of IRB or IEC Approval. Can you confirm and clarify any intended distinction?
An Acknowledgement of Receipt in 4.1.1 is just to show the submission was received, but has no implications of approval. In 4.1.2, an acknowledgement can actually replace an approval in some circumstances. 4.1.2 is where you would look for any kind of approval or acceptance by the IRB/IEC. If confusing to users, the sub-artifact Acknowledgement of Receipt in 4.1.1 may be deleted.

February 24, 2106


Author: rammellel

Records management consultant to the life sciences / pharmaceutical industry

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