For studies that are supported by DAIDS but DAIDS is not the IND sponsor, are there different requirements for protocol registration?
A. Site participating in studies where DAIDS is not the IND sponsor will be required to submit the same documents to the DAIDS 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.
Related Questions
- Do you intend to provide requirements on how the protocol stack should be integrated with Voice over IP applications, support different voice codecs etc and if so when will you provide this?
- Im 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?
- What should network sites do if they have network requirements in addition what is required by DAIDS for protocol registration?
