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About DAIDS and the DAIDS RSC

The Division of AIDS (DAIDS) was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the Division supports a global research portfolio on HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-free Generation,” the Division continually develops and supports the research infrastructure and scientific expertise needed to enable innovative approaches aimed at:


    1) Halting the spread of HIV through effective and acceptable prevention strategies and a preventive vaccine

    2) Treating and curing HIV infection

    3) Establishing treatment and prevention strategies for the HIV co-infections and co-morbidities of greatest significance

    4) Partnering with scientific and community stakeholders to implement effective interventions


Organizationally, DAIDS is comprised of the Office of the Director (OD) and four scientific programs. Within the OD are the: 1) Workforce Operations, Communications, and Reporting Branch; 2) Science Planning and Operations Branch; 3) Office of Clinical Site Oversight, which includes the Pharmaceutical Affairs Branch, Monitoring and Operations Branch, Africa and the Domestic Partners Branch, and Asia and the Americas Branch; and 4) Office for Policy in Clinical Research Operations, which includes the Regulatory Affairs Branch, Clinical Research Resources Branch, and the Protection of Participants, Evaluation and Policy Branch.


The DAIDS Regulatory Support Center (RSC) is a contract-based organization that provides comprehensive clinical regulatory support for all NIAID/DAIDS-supported and/or -sponsored network and non-network clinical trials, both domestic and international. The DAIDS RSC provides day-to-day support for all regulatory activities using the DAIDS Enterprise System (DAIDS-ES) within the NIAID Clinical Research Management System (NCRMS).  Use of the DAIDS-ES enables the DAIDS RSC to exchange information directly with database systems utilized by NIAID/DAIDS-sponsored Group/Network Operations Offices, Data Management Centers, and other collaborators, to ensure efficient and effective integration of regulatory information in support of NIAID/DAIDS. The DAIDS RSC Contracting Officer’s Representative (COR) provides technical oversight of the DAIDS RSC Contract.


For more information about DAIDS collaborators and their roles in the clinical trial lifecycle, view the DAIDS Collaborators Tool.

For information on DAIDS RSC accomplishments, view the DAIDS RSC Contract Highlights 2010-2017.

This page describes several DAIDS groups and the DAIDS RSC Teams who support them.

The DAIDS Regulatory Affairs Branch (RAB) and the DAIDS RSC Regulatory Team

DAIDS 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 U.S. FDA for clinical trials sponsored/funded by DAIDS. RAB members sign the Form FDA 1571 for DAIDS-sponsored INDs.


The DAIDS RSC Regulatory Team works closely with DAIDS RAB and provides support by reviewing protocol documents for regulatory compliance, and preparing and filing 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.

Regulatory Policy Issues

Mary Anne Luzar, Ph.D.
Chief, RAB

Email Email: Mluzar@niaid.nih.gov
Phone Phone: 1 (301) 435-3737
Fax Fax: 1 (301) 402-1506

Regulatory Documentation

Porche Henry, Ph.D.

Email Email: Regulatory@tech-res.com
Phone Phone: 1 (301) 897-7452
Fax Fax: 1 (301) 897-7400
Phone Hotline: 1 (301) 897-1706

The DAIDS Protection of Participants, Evaluation, and Policy Branch (ProPEP) and the DAIDS RSC Human Subjects Protection Team

DAIDS ProPEP is a branch of DAIDS within the Office of Policy in Clinical Research Operations (OPCRO). DAIDS ProPEP provides subject matter expertise on human subjects protections matters (i.e., 45 CFR 46, 21 CFR 50, and 21 CFR 56), IRB/EC requirements, and HSP/GCP compliance issues. ProPEP also develops and maintains DAIDS policy documents to promote harmonization and to ensure compliance with applicable laws, regulations, guidelines, and policies, and serves as the DAIDS liaison to Office for Human Research Protections (OHRP).


The DAIDS RSC Human Subjects Protection (HSP) Team works closely with DAIDS ProPEP and provides support by reviewing all Informed Consents (ICs) during review at the P/CSRC and Regulatory Review stages. These include ICs for DAIDS-sponsored network and investigator-initiated protocols supported through DAIDS' grants. The DAIDS RSC HSP Team is also responsible for the translation of Sample ICs to Spanish.

Informed Consent Issues & Human Subjects Protection Issues

Judith Brooks
Chief, Protection of Participants, Evaluation, and Policy Branch (ProPEP)

Email Email: Brooksju@niaid.nih.gov
Phone Phone: 1 (301) 594-6626
Fax Fax: 1 (301) 402-1506

Human Subjects Protection (HSP)

Eva Hymel, M.S.

Email Email: DAIDSRSC-HSP@tech-res.com
Phone Phone: 1 (301) 897-7443

The DAIDS Protocol Registration Team (PRT) and the DAIDS RSC Protocol Registration Office

The DAIDS Protocol Registration Team (PRT) is a Team within OPCRO responsible for managing the Protocol Registration (PR) process, which includes oversight of the DAIDS RSC PRO.


The process of completing and submitting the site-specific informed consent, IRB/EC approval letter, FDA 1572 Form, and Investigator of Record CV is called Protocol Registration. Protocol Registration may occur more than once during the course of the protocol. Subsequent protocol registrations are called amendment registrations.


The DAIDS RSC Protocol Registration Office (PRO) works closely with DAIDS PRT and provides support by reviewing and tracking all required clinical site regulatory documents for all protocol versions at each Clinical Research Site to ensure that all documents needed to fulfill the study sponsor’s regulatory obligations relating to protocol registration are reviewed for completeness and accuracy within the specified timeline set up by the sponsor, as stated in the DAIDS Protocol Registration Policy and Procedures Manual, and in compliance with 21 CFR 50, 21 CFR 56, and 45 CFR 46. The DAIDS RSC PRO also plans and conducts trainings on protocol registration procedures as requested by DAIDS.

Protocol Registration Policy Issues

Melissa Kin, M.S., M.B.A.
Protocol Registration Team Leader, RAB

Email Email: Mkin@niaid.nih.gov
Phone Phone: 1 (240) 292-4939
Fax Fax: 1 (301) 402-1506

Protocol Registration Office

John Hojnowski

Email Email: Protocol@tech-res.com
Phone Phone: 1 (301) 897-7457
Fax Fax: 1 (301) 897-7400
Phone Hotline:

1 (301) 897-1707

The DAIDS Safety and Pharmacovigilance Team (SPT) and the DAIDS RSC Safety ​Office

The DAIDS Safety and Pharmacovigilance Team (SPT) is a Team at DAIDS within OPCRO that is responsible for safety and pharmacovigilance activities related to clinical trials sponsored/funded by DAIDS.


The DAIDS RSC Safety Office works closely with DAIDS SPT and provides support by collecting adverse events reported by sites participating in DAIDS-supported studies, processing the events for review by the DAIDS Medical Officer, and preparing the reports for transmittal to the Food and Drug Administration (FDA), if required. They also support DAIDS SPT in  establishing internal procedures and developing Safety training for the Clinical Research Sites.

Expedited and Serious Adverse Events Issues

Carol Worrell, M.D.
Director of OPCRO, and Safety and Pharmacovigilance Team Lead

Email Email: worrellc@niaid.nih.gov
Phone Phone: 1 (240) 669-5421
Fax Fax: 1 (240) 627-3111

IND Safety Report Issues

Mary Anne Luzar, Ph.D.
Chief, RAB

Email Email: Mluzar@niaid.nih.gov
Phone Phone: 1 (301) 435-3737
Fax Fax: 1 (301) 402-1506

Serious Adverse Events

Anuradha Jasti, M.D.

Email Email: DAIDSRSCSafetyOffice@tech-res.com
Phone Phone: 1 (301) 897-7448
Fax Fax: 1 (800) 275-7619
Phone Hotline: 1 (301) 897-1709
1 (800) 537-9979

Safety Information Center

Archita Chatterjee, M.S.

Email Email: RIC@tech-res.com
Phone Phone: 1 (301) 897-7438
Fax Fax: 1 (800) 275-7619
Phone Hotline: 1 (301) 897-1708

The DAIDS RSC Case Report Form Management Team

With DAIDS approval, Clinical Research Sites can send their Case Report Forms (CRFs) to DAIDS via the DAIDS RSC for storage. The DAIDS RSC works closely with DAIDS RAB and DAIDS ProPEP to facilitate this process for the sites and to ensure that only documents that were approved by DAIDS are received for storage. The DAIDS RSC CRF Team reviews the submitted documents, and once any issues are resolved, transports them to a government storage facility.

Case Report Form (CRF) Management

Porche Henry, Ph.D.

Email Email: crf@tech-res.com
Phone Phone: 1 (301) 897-7452

The DAIDS Clinical and Prevention Science Review Committees (C/PSRC) and the DAIDS RSC Science Review Committees (SRC) Team

The DAIDS Clinical Science Review Committee (CSRC) is the internal SRC responsible for the programmatic review of DAIDS-sponsored therapeutic protocols. The DAIDS Prevention Sciences Review Committee (PSRC) is the internal SRC responsible for the programmatic review of DAIDS-sponsored vaccine and prevention protocols. Reviews 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.

The DAIDS RSC SRC Team supports the DAIDS CSRC and PSRC, providing technical and administrative support for the SRC reviews of concept proposals and protocols. The DAIDS RSC SRC Team receives and tracks materials from the SRCs, circulates these documents as appropriate, and prepares a summary of the Committee meetings.

CSRC/PSRC

Rebecca Sweet, Ph.D.

Email Email: DAIDSRSC-CSRC@tech-res.com
Email Email: DAIDSRSC-PSRC@tech-res.com
Phone Phone: 1 (301) 897-1778

The DAIDS RSC Clinical Study Information Office

The DAIDS RSC Clinical Study Information Office (CSIO) receives and abstracts protocol and/or contact information into the DAIDS-Enterprise System (DAIDS-ES) within NCRMS for use by the NIAID/DAIDS and their collaborators in support of DAIDS-supported and/or -sponsored clinical trials. The DAIDS RSC CSIO works closely with the DAIDS RSC Contracting Officer’s Representative (COR), other applicable DAIDS subject matter experts (SMEs), and DAIDS Collaborators to ensure information in the DAIDS-ES is current and accurate.

Clinical Study Information Office (CSIO)

Matthew Riggs

Email Email: CSIO@tech-res.com
Phone Phone: 1 (301) 897-1766
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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).