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Clinical Trials Management and Support

About

What services does this resource provide?

The Clinical Trials Management and Support program provides services to support the work of the Office of Clinical Research Affairs (OCRA) in the Division of Microbiology and Infectious Diseases (DMID). OCRA facilitates the implementation and conduct of DMID extramural clinical research and provides oversight of the safety of human subjects participating in DMID-sponsored clinical trials.

The Clinical Trials Management and Support program:

Assesses and helps prepare sites for readiness to perform trials by training personnel, preparing protocol and protocol-related documents and materials
Monitors and assists clinical sites to ensure that clinical trials are conducted in accordance with International Conference on Harmonization/Good Clinical Practices guidelines
Monitors safety by implementing a pharmacovigilence program to report Serious Adverse Events (SAEs) and provides logistical support to DMID clinical sites to establish and maintain Safety Monitoring Committees and Data and Safety Monitoring Boards to review DMID protocols.

Where are services provided?

Services are provided by PPD (non-Government link).

Related Resources and Information

Contact Info

Angelita Ray
Chief, Clinical Trials Management Section
E-mail: rayap@niaid.nih.gov

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Contact Info

Angelita Ray
Chief, Clinical Trials Management Section
E-mail: rayap@niaid.nih.gov