I am reaching out to ask for assistance on the following questions on TMF metrics as I am having trouble finding standard guidelines:
1. What is the industry guideline for the rejection rate of documents in the eTMF? I am getting a rejection rate range of 1-2.5% for the eTMFs that I am managing , but I am unsure if that is acceptable per the industry standards.
2. If a sponsor is not holding the eTMF internally, then what should be included in their oversight to the CROs eTMF:
Should I (TMF officer) do Inspection Readiness checks starting with 15% and then going up as needed monthly?