Protocol Registration Form FDA 1572/DAIDS Investigator of Record (IOR) Form Frequently Asked Questions
How should names be listed on the Form FDA 1572/DAIDS IoR Form?
Sites should use the complete legal name (full first and last name) on all documents. It is recommended that sites use the name that appears on legal documents (e.g., medical license, passport, etc.) on all documents.
Where should sites keep original Form FDA 1572s/DAIDS IoR Forms?
All originals should be maintained in the regulatory files at the site.
Can sub-investigators who are listed on the Form FDA 1572/DAIDS IoR Form sign the DAIDS Protocol Registration Translation Confirmation Form if the IoR is traveling and not available?
It is acceptable for a sub-IoR to sign the DAIDS Protocol Registration Translation Confirmation Form if this duty is delegated to a sub-IoR by the IoR.
Although the FDA does not require an immediate change to the Form FDA 1572 if a sub-investigator leaves the site, DAIDS does. Does that mean I still need to update the Form FDA 1572 immediately?
If there is any major change to the information on the current Form FDA 1572 or DAIDS IoR Form, a revised Form FDA 1572/DAIDS IoR Form must be submitted to the DAIDS PRO within 30 calendar days.
Should the box marked “Curriculum Vitae” be checked always or only if CV provided for initial registration and when updated?
Sites should check the box if the IoR’s CV has been submitted to the DAIDS PRO with a registration submission.
What if an RE/Approving Entity only reviews and approves the initial version of a protocol? Should the RE/Approving Entity be listed on the Form FDA 1572/DAIDS IoR Form? What should I do when amendments are submitted?
The Form FDA 1572/DAIDS IoR Form must list all IRBs/ECs/REs/Approving Entity(ies) that are responsible for the review and approval of a clinical trial at a CRS prior to the CRSs initiation of the protocol. If a RE/Approving Entity is not responsible for the review of full version amendments, letters of amendment or changes to the CRS’s site-specific ICFs, the CRS Leader or IoR should document the IRB/EC/RE/Approving Entity procedures with a memo to the DAIDS PRO or in the DPRS when submitting registration materials.
If a site submits materials stating that their local IRB’s approval is being performed by another IRB, does the local IRB/EC that is waiving approval need to be listed on the Form FDA 1572/DAIDS IoR Form?
No. The site should list only the IRB/EC that responsibilities have been delegated to on the Form FDA 1572/DAIDS IoR Form.
Our main clinical site has an additional/alternate location where participants will be seen by the same study staff from the main site, should we list the name and address of both locations on the Form FDA 1572/DAIDS IoR Form?
Per the DAIDS Protocol Registration Manual, sites must list the names and addresses of all locations where the clinical trial will be conducted. This includes all facilities where participants will be seen and study procedures performed.