DMID Clinical Research Policies and Standard Procedure Documents

Introduction

The Office of Clinical Research Affairs (OCRA) is found within the Division of Microbiology and Infectious Diseases (DMID) at the National Institute of Allergy and Infectious Diseases (NIAID). Formerly a part of Clinical Regulatory Affairs Branch (CRAB), OCRA was created in 2000 to facilitate a standardized approach to improving public health through the clinical evaluation of vaccines, biologics, and drug treatment strategies. OCRA is strategically comprised of three functional areas. These include the Clinical Group, the VTEU Program, and the Clinical Trials Management Section.

The Clinical Group is a team of medical officers and a pharmacist who have specialized clinical expertise. They provide early input in the protocol development process regarding the clinical and scientific feasibility of DMID-sponsored studies, as well as continued oversight on clinical protocol implementation.

The VTEU Program includes nurse consultants responsible for coordinating the clinical evaluation of vaccine and clinical studies performed at seven NIH-funded Vaccine and Treatment Evaluation Units (VTEUs). They coordinate clinical research activities, facilitate communication among the VTEUs and DMID, and serve as the VTEU representative within DMID.

The Clinical Trials Management Section (CTMS) is composed of nurse consultants and health specialists. The CTMS performs management, operational, and logistical functions in support of domestic and international DMID sponsored studies.

To achieve its goal, OCRA’s mission is:

1. To promote a global approach in conducting clinical research that ensures excellence of standards both domestically and internationally.

2. To serve as a conduit for the review, evaluation, and improvement of clinical research protocols and investigational product development in conjunction and consultation with program branches, Office of Regulatory Affairs (ORA), Office of Biodefense Research Affairs (OBRA), Office of Scientific Coordination and Program Operations (OSCPO), and the Office of the Director (OD).

3. To collaborate with its VTEU contracts, DMID branches, and other DMID investigators and partners as a vehicle for developing novel vaccine and drug therapeutics.

4. To provide oversight of the safety of the human subjects participating in DMID-sponsored extramural clinical research through a centralized pharmacovigilance and safety monitoring program.

5. To provide the resources that facilitate the implementation and conduct of clinical research within extramural DMID.