Protocol Registration General Frequently Asked Questions

What does supported by NIAID/DAIDS mean? Does it mean financially supported?

In addition to financial support, “supported” also means direct and indirect funding, other types of tangible support, such as providing lab or data management services, regulatory support, study drug supply for research activities. See the DAIDS glossary for definition of “DAIDS supported”.

For studies that are supported by DAIDS but DAIDS is not the IND sponsor, are there different requirements for protocol registration?

Sites participating in studies where DAIDS is not the IND sponsor will be required to submit the same documents to the DAIDS Protocol Registration Office (PRO) as studies where DAIDS is the IND sponsor. The Protocol Registration algorithm defines the protocol registration requirements when DAIDS does not hold the IND, but provides funding. See the algorithm associated with the Protocol Registration Policy for additional details.

What should network sites do if they have network requirements in addition to what is required by DAIDS for protocol registration?

In general, it is recommended that if the networks/other groups have additional requirements for their studies, networks/other groups should develop guidance documents clearly stating the requirements sites must follow in addition to the DAIDS requirements.

I'm the new Study Coordinator at my site. Could you please update the DAIDS Protocol Registration System (DPRS) so I start receiving all the necessary communications/reports?

Sites and new personnel should contact your DAIDS Office for Clinical Site Oversight (OCSO) representative or your DAIDS Program Officer to initiate this process.

Can my submission be expedited?

If you need a submission expedited, please send an e-mail to the DAIDS PRO requesting an expedited review and the reason an expedited review is required. A determination will be made by DAIDS on a case by case basis.

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