Standard DAIDS Protocol Development Steps by Role
Protocol
Development Step
DAIDS
CTA Initiation
CTA initiated
Protocol Team
DAIDS RSC
CTA development support
initiated
Team submits protocol to
DAIDS for C/PSRC
C/PSRC Review
C/PSRC Review
C/PSRC Review support
Team submits revised
protocol to DAIDS
DAIDS approves protocol
for Regulatory Review
Regulatory Review
Team submits protocol to
RSC for Regulatory Review
Regulatory Review and
Processing
Regulatory Review
Team submits revised
protocol to RSC for Medical
Officer Review
Medical Officer Review
Medical Officer Review
Processing
Medical Officer Review
Team submits revised
protocol to RSC for Final
RAB sign-off
Final RAB Sign-off
Final RAB sign-off
Final RAB sign-off processing
Protocol submitted to FDA and
Ops for distribution to sites
CTA finalized
CTA finalization support
IB distributed/PIs posted
Sites can begin to submit
materials to their IRB/EC and
other regulatory agencies
Regulatory
Requirements Activities
Protocol Registration
If there are clinical hold
issues, Team replies to
FDA’s request for information
(in most cases, there is not a
clinical hold by the FDA, so
protocol implementation can
proceed)
RSC notifies Team that there
are no Regulatory holds
Protocol Registration (Materials
received and processed by
PRO)
Protocol Registration
Study opens
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DAIDS and DAIDS RSC Groups Involved in Protocol Development
DAIDS:
CTAT - The Clinical Trials Agreement Team (CTAT) negotiates CTAs and other research
agreements between DAIDS and industry collaborators (study product manufacturers).
C/PSRC - The Clinical/Prevention Science Review Committee (C/PSRC) is a reviewing body
instituted by DAIDS to review Concept Sheets, Grants, Protocols, Sub-studies, and
Amendments to Protocols developed by various programs seeking DAIDS support. The
C/PSRC reviews each proposal to assess its scientific merit, plans to ensure volunteer
safety, and compliance with ethical and regulatory requirements. Support of the clinical
research proposal is weighed in relation to the National Institute of Allergy and Infectious
Diseases (NIAID) HIV AIDS scientific priorities, and other planned or ongoing clinical
studies. Prior to the implementation of any proposal, C/PSRC approval must be obtained.
The RSC provides support for these activities with the distribution of documents for review,
agendas for meetings, preparation of Consensus Memos reflecting the Committees’
comments, and distribution of the Committees’ responses to protocol teams.
MO - The Medical Officer (MO) is a DAIDS staff member or member from another sponsoring
Institute or Centers that monitors the safety and efficacy of the intervention(s) for ongoing
studies and those in development.
ProPEP - The Protection of Participants, Evaluation, and Policy Branch (ProPEP) provides
guidance for the DAIDS RSC Human Subjects Protection team’s reviews of informed
consents and Spanish Translations.
PRT - The Protocol Registration Team (PRT) within the Office of Clinical Research Policy and
Resources (OPCRO) responsible for managing the Protocol Registration System, which
includes oversight of the DAIDS PRO.
RAB - The Regulatory Affairs Branch (RAB) within DAIDS is part of OPCRO. RAB performs
regulatory surveillance over clinical trials sponsored/funded by DAIDS.
The DAIDS Regulatory Support Center (RSC):
DAIDS RSC CTA - The Clinical Trials Agreement (CTA) team supports and facilitates the
negotiation of CTAs and other research agreements between DAIDS and industry
collaborators (study product manufacturers).
DAIDS RSC HSP - The Human Subjects Protection (HSP) team is responsible for reviewing all
Informed Consents (ICs) during review at the C/PSRC, Regulatory Review, and Protocol
Registration. These include ICs for DAIDS-sponsored network and investigator-initiated
protocols supported through DAIDS’ grants. The HSP team is responsible for the translation
of Sample ICs to Spanish.
DAIDS RSC Regulatory - The Regulatory Team reviews Protocol Documents for regulatory
compliance, and prepares and files new Investigational New Drug Applications (INDs) and
amendments to existing INDs in compliance with the procedural and substantive
requirements of 21 CFR § 312. Examples of submissions to the FDA include original IND
Applications, Annual Reports, Safety Reports, and Responses to FDA Requests for
Information.
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July 8, 2013
DAIDS RSC PRO - The Protocol Registration Office (PRO) registers and de-registers sites that
will be running studies and enrolling participants. This involves collecting and processing
ICs, Institutional Review Board (IRB)/Ethics Committee (EC) approval letters, Food and
Drug Administration (FDA) 1572 Forms, Investigator of Record (IoR) forms, and the
Principal Investigator’s curriculum vitae. Protocol registration may occur more than once
during the course of the protocol. Subsequent protocol registrations are called amendment
registrations.
DAIDS RSC RIC - The Regulatory Support Center Safety Information Center (RIC) distributes
Investigators’ Brochures (IBs), Package Inserts (PIs), Safety Reports, Data Safety
Monitoring Board (DSMB) Reports, and Risk Lists to the FDA, Study Coordinators, drug
companies, and DAIDS.
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