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Currently, we do not list the PI on the DOA log with all the Sub-Is and Key Personnel, rather we have a statement at the top of the DOA that the PI signs accepting full responsibility for the study, then they delegate tasks to properly trained individuals on the log portion of the document. We have a monitor that is requiring that we had the PI to the log and have her delegate tasks to herself and is going to list it as a finding if we do not.
So our questions / arguments against this are:
1. Is there any documented regulatory requirement for this? (it seems silly to have a PI delegate to themself)
2. If we have the PI delegate tasks to herself, should she delegate all tasks possible to herself since she is the PI and is ultimately responsible for them? or should she only delegate the tasks she is actually doing? If we only delegate some tasks to the PI, but per 1572 she is responsible for all of them, the documents are not congruent. If we delegate all tasks to the PI, she is not trained and/or legally able to perform some of the tasks – such as drug dispensation or specimen processing and shipping (IATA).
Would really like to hear what others are doing or would do?
I’ve seen it done both ways, but I agree with you. The PI is responsible for the conduct of all tasks and therefore they do not have to delegate tasks to themselves in the task section of the DOA log. The actual DOA Log itself is not a regulatory requirement but rather the log is a great way to ensure compliance with ICH GCP E6 R2:
- Section 4.1.5 The Investigator should maintain a list of appropriately qualified and trained persons to whom the Investigator has delegated significant study –related duties.
- Section 8.3.24 “signature sheet” to document signatures and initials of all persons authorized to make entries and/or corrections on CRFs.
If your site/institution has an SOP or Guidance Document that speaks to your process regarding the DOA log, my recommendation would be to present it to the study monitor.
