The lead site at the initial submission has chosen pathway 2. One of the additional sites submits a protocol amendment during the study and their documentation is aligned with pathway 3. They have now re-aligned the PICF pathway. Is that possible?
The HREC administration keeps a record of the lead site’s PICF pathway at the initial submission. If a site tries to change the pathway, the HREC administration will return the documentation, along with an explanation that it does not match the study pathway. The only exception to this would be when a single centre study on PICF pathway 1 has changed to a multi-centre study. The Sponsor needs to determine who is responsible for unpacking the PICF and moving the study to PICF pathway 2 or 3. In this case, the submitting site should also explain the change in the pathway to the HREC. Providing as much information as possible will help the administrator understand why the documentation change is being submitted.