How should names be listed on the Form FDA 1572/DAIDS IoR Form?
Where should sites keep original Form FDA 1572s/DAIDS IoR Forms?
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?
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?
Should the box marked “Curriculum Vitae” be checked always or only if CV provided for initial registration and when updated?
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?
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?
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?
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This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201000013C, entitled NIAID DAIDS Regulatory Support Center (RSC).