This message was posted by a user wishing to remain anonymous
Hi,
I work in a pharma company and I'm helping set up an internal SOP for requests for FDA Form 1572 waivers if an investigator at a non-U.S. clinical trial site refuses to sign the form (based on the 2021 guidance/Q&A on this topic). Some good questions have come up as I discuss this guidance with other functional lines. I'm afraid I don't know the answer to these since my knowledge is limited to that of the guidance documents, and I'm not sure how other regulatory colleagues are addressing these. I welcome any insights/thoughts you have about this process.
1) Has FDA shared in any forum when the guidance is expected to be final, and what are the consequences of noncompliance?
2) Do we know of any examples of consequences of non-compliance?
3) Are other Sponsors requesting retrospective waiver requests, or is the industry focusing on prospective site initiations?
4) Does anyone have experience submitting this information for proposed, rather than selected, sites?
I really appreciate any thoughts on this, as I figure I'm not the only one trying to figure out the most straightforward and fastest way to be compliant while also not slowing down clinical studies.