Regulatory Compliance and Human Subjects Protection Branch (RCHSPB)

The Clinical Trials Management (CTM) Group

• Monitors clinical trials to ensure that human subjects are protected, validates the integrity of the data collection and recording process, and ensures compliance with all appropriate regulatory bodies and the ICH/GCP Guidelines. The team consists of a Clinical Research Oversight Manager, a Clinical Trials Manager, a Project Manager, and numerous Clinical Research Associates (CRAs, Monitors).
• Provides services such as developing case report forms, protocol study manuals, randomization and treatment allocation codes, and subject study numbers for the investigators in the intramural community and those studies sponsored by the NIAID intramural programs, both domestic and international
• Reviews draft protocols, focusing on the "Data Management Plan," "Protocol Monitoring Plan," and "Plan for Use and Storage of Biological Samples" sections of the Protocol as well as on the study procedures, table of events/study schedule, study agent/dosing requirements, and feasibility of procedure implementation, when applicable