Download a PDF version of the Protocol Development Lifecycle
| Study Status | Milestone | Entity and Key Points |
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Proposed The network leadership has decided to commit resources on the proposal. For non-network initiatives, DAIDS has decided to commit resources on the proposal. |
Proposal Approved for Protocol Development |
Network Ops Center/Protocol Team sends proposal for protocol to DAIDS. DAIDS approves proposal for development. |
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In Development Protocol is being developed. |
Clinical Trial Agreement (CTA) Initiation |
DAIDS CTAT and DAIDS RSC CTA Team initiate and negotiate CTAs between DAIDS and Industry Collaborators (study product manufacturers). |
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Protocol Reviewed by DAIDS Clinical/ Prevention Scientific Review Committee (C/PSRC) |
Protocol Team signs-off on protocol draft and sends the protocol to DAIDS. CSRC or PSRC reviews the protocol to assess its scientific merit, and to ensure participant safety, and regulatory compliance. DAIDS RSC SRC prepares the Consensus Review, which is then sent to the Protocol Team. Protocol Team addresses the major comments of the committee and submits a revised protocol to DAIDS RSC. |
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Regulatory Review |
DAIDS RSC Regulatory and DAIDS RSC HSP work with DAIDS RAB and DAIDS ProPEP, respectively, to carry out a full regulatory review of a new protocol or an amendment regulatory review for a protocol amendment and send their comments to the Protocol Team . Protocol Team addresses regulatory comments and sends revised protocol to DAIDS RSC who reviews the updates and then sends the protocol to the DAIDS Medical Officer (MO). |
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DAIDS Medical Officer (MO) Review and Sign-off |
DAIDS MO reviews the protocol and either provides sign-off or sends comments that need to be addressed to DAIDS RSC Regulatory who forwards the comments to the Protocol Team. Protocol Team addresses MO comments and if necessary sends revised protocol to DAIDS RSC Regulatory who, along with DAIDS RSC HSP, reviews the updates and then sends the protocol to DAIDS RAB. |
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Final DAIDS RAB Review and Sign-off |
DAIDS RAB reviews the revised protocol and provides sign-off. DAIDS RSC Regulatory submits the finalized protocol to the FDA (for IND studies) and sends it to Network Ops Center for distribution to Sites. |
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Pending Final protocol version has been approved by DAIDS and distributed to field, but has not yet met all conditions for opening to accrual. |
Regulatory Activities |
DAIDS CTAT and DAIDS RSC CTA Team finalize CTAs with collaborators. DAIDS RSC Safety Information Center (RIC) distributes IB/PIs (and other DAIDS Safety Information Types) to the Networks and Sites as requested. Protocol Team replies to any FDA requests for information. Team also ensures study agents/products are ready, data management requirements met, and any protocol specific requirements are met. |
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Ethical Review |
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Using the PRO Manual, Sites submit protocol registration materials (e.g., Site Informed Consent forms, IRB/EC/RE approval letters, FDA 1572 forms, IOR forms, CVs, etc.) to DAIDS RSC PRO via the DAIDS Protocol Registration System (DPRS). DAIDS PRO collects registration materials from Sites and when all documents have been received, they work with DAIDS PRT to review and approve the Site’s registration. |
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Open to Accrual Study has met all conditions for opening and is officially open and awaiting the first enrollment. |
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Enrolling The study has enrolled the first participant and is continuing to accrue more subjects. |
The study has enrolled the first participant and is continuing to accrue more subjects. |
Sites continue to submit required materials (e.g., new/updated FDA 1572 forms, CVs, to DAIDS RSC PRO). During this time, the study may be temporarily closed (paused) to study agents/products, temporarily closed (paused) to accrual and study agents/ products, or temporarily closed to accrual and then the protocol can reopen, or enrollment can be closed. |