| Term |
Definition |
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Consensus Review
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A Consensus Review is a summary of the C/PSRC meeting that communicates the C/PSRC comments and decision to the Protocol Team.
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CSRC
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The Clinical Scientific Review Committee (CSRC) is the Division of AIDS internal scientific review committee responsible for the programmatic review of therapeutic protocols sponsored by DAIDS. The review will include careful assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols. Scientific representatives from collaborating NIH Institutes and Centers participate as appropriate.
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DAIDS
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The Division of Acquired Immunodeficiency Syndrome (DAIDS) is the division within the NIAID that has the primary responsibility for basic and clinical research on HIV/AIDS.
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DAIDS CTAT
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The DAIDS Clinical Trials Agreement Team (CTAT) negotiates CTAs and other research agreements between DAIDS and collaborators.
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DAIDS Medical Officer (MO)
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The DAIDS Medical Officer (MO) is a staff member that monitors the safety and efficacy of the intervention(s) for ongoing studies and those in development.
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DAIDS ProPEP
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DAIDS ProPEP develops and maintains DAIDS policy documents to promote harmonization and to ensure compliance with applicable laws, regulations, guidelines, and policies. They perform quality assurance assessments to evaluate compliance with DAIDS policies and procedures, and are a consultative resource regarding human subjects regulations (i.e., 45 CFR 46 and 21 CFR 50, 56), as well as related HSP/GCP compliance issues.
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DAIDS PRT
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The DAIDS Protocol Registration Team (PRT) is a team within OPCRO responsible for managing the PR System, which includes oversight of the DAIDS PRO.
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DAIDS RAB
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The DAIDS Regulatory Affairs Branch (RAB) is a branch of DAIDS within the Office of Policy in Clinical Research Operations (OPCRO). RAB is responsible for regulatory strategy across the DAIDS programs. RAB performs regulatory management and surveillance and is the official DAIDS liaison to the US FDA for clinical trials sponsored/funded by DAIDS. RAB members sign the Form FDA 1571 for DAIDS-sponsored INDs.
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DAIDS RSC
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The DAIDS Regulatory Support Center (RSC) is a contract based organization within Technical Resources International, Inc. charged with providing regulatory support to OPCRO, DAIDS.
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DAIDS RSC CTA Team
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The DAIDS RSC Clinical Trials Agreement (CTA) Team supports DAIDS CTAT in negotiating CTAs and other research agreements between DAIDS and collaborators.
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DAIDS RSC HSP
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The DAIDS RSC Human Subjects Protection (HSP) Team conducts reviews of the Sample Informed Consents (SICs) of protocols at DAIDS-specified stages of protocol development, and coordinates the translation of SICs and related documents into Spanish.
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DAIDS RSC PRO
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The DAIDS RSC Protocol Registration Office (PRO) receives and processes all protocol registration materials submitted by sites participating in DAIDS-supported and/or -sponsored clinical trials.
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DAIDS RSC Regulatory
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The DAIDS RSC 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 ยง 312.
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DAIDS RSC Safety Information Center (RIC)
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The DAIDS RSC Safety Information Center (RIC) distributes safety information from drug company collaborators (Investigator Brochures and Package Inserts), findings in DAIDS studies (IND safety reports and MedWatch reports), studies being conducted by the pharmaceutical company using the same study agent as in a DAIDS-sponsored/supported study (Safety Memos), as well as publicly available safety information (Safety Alerts and Safety Notices).
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DAIDS RSC SRC
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The DAIDS RSC Scientific Review Committee (SRC) Team provides technical and administrative support for the review of concept proposals and protocols by DAIDS C/PSRC.
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Industry Collaborators
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Industry Collaborators include relevant drug companies, non-profit organizations, or other governmental agencies that may be a party to the CTA or CDA.
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IRB/IEC
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The Institutional Review Board/Ethics Committee (IRB/EC) is a board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of participants in research. The IRB/EC reviewing DHHS sponsored research must be registered with OHRP and identified on the institute FWA.
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Milestone
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An event that occurs within a Study Status. Please note that some Milestones are triggering events for a change in Study Status.
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Network Ops Center/Protocol Team
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The Network Ops Center supports the development of the protocol and supports the clinical trial. The Protocol Team is a team of individuals comprised of grantees, investigators, statisticians, and other protocol support personnel who work to develop concepts into NIAID (DAIDS)-funded and/or -sponsored research studies. DAIDS Medical Officers may be involved as members of this team.
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| Protocol Registration |
DAIDS process to ensure all sites participating in DAIDS supported/sponsored research conduct the research in accordance with the DAIDS requirements. |
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Protocol Team
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The Protocol Team is a team of individuals comprised of grantees, investigators, statisticians, and other protocol support personnel who work to develop concepts into NIAID (DAIDS)-funded and/or -sponsored research studies. DAIDS Medical Officers may be involved as members of this team.
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PRSC
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The Prevention Scientific Review Committee (PSRC) is the Division of AIDS internal scientific review committee responsible for the programmatic review of vaccine and prevention protocols sponsored by DAIDS. The review will include careful assessment of the scientific objectives, design, safety, ethics, and feasibility of proposed research protocols. Scientific representatives from collaborating NIH Institutes and Centers participate as appropriate.
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Sites
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Clinical Research Sites (CRS) are discrete locations (e.g., hospitals, outpatient clinics, health maintenance organizations, community health centers, private practices, clinics) supported and/or sponsored by NIAID (DAIDS) where qualified professionals conduct clinical research in accordance with Good Clinical Practice and applicable regulations.
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Study Status
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The current stage of development or implementation of a protocol.
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