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Regulatory Affairs

The RTI Office of Research Protection (ORP) ensures compliance with all regulations related to the protection of human research subjects and assists study investigators in developing appropriate study procedures

Human Subjects Protection

The RTI Protection of Human Subjects Committee (PHSC) consists of three Institutional Review Boards (IRBs), each of which meets monthly to ensure timely review of all studies. All biomedical and behavioral research conducted by us under a grant or a contract involving human subjects must have the approval of this committee before data collection or analysis begins. The Office for Human Research Protections (OHRP) of the DHHS has granted a Federal-Wide Assurance (FWA #3331) to RTI that grants the right to independently review and approve studies. In turn, OHRP has the right to audit our IRB records or any study's procedures at any time to ensure our compliance with the federal regulations regarding research with human subjects.

IRB Coordination

Our staff members assist clinical sites with all aspects of IRB coordination and communications, including support with protocol and study forms review packages, interim reports, maintenance of regulatory files, and annual updates. We assist sites with any necessary modifications required to comply with site-specific IRB requirements, advocacy groups, or cultural norms. Each site sends required documentation of local clearance approvals and copies of clearance packages and consent forms to RTI before data collection. Site regulatory files, including regulatory correspondence, are created and maintained at RTI. We also track and remind sites of annual updates and approval schedules.

Regulatory Filing and Submissions

Our researchers serve as the regulatory liaison and a resource for regulatory submissions to the U.S. Food and Drug Administration (FDA). Strategic regulatory plans, timelines, and milestones, are always discussed early in the development of a clinical program with study investigators, the protocol team, the medical monitor, Scientific Advisory Committee, and appropriate quality assurance staff. Our regulatory staff organize, format, assemble, and track submission documents and packages for FDA approval and submit annual updates as required.

Monitoring Adverse Events and Patient Safety

Our staff members routinely coordinate and report safety data, such as adverse events (AEs) and significant adverse events (SAEs), to project data safety and monitoring boards (DSMBs), IRBs, and scientific advisory committees during the conduct of clinical studies. By NIH guidelines, IRBs should determine what type of monitoring is appropriate for each protocol based on the level of risk and the number of subjects to be studied. Our researchers collaborate with study investigators to efficiently implement patient safety monitoring.

Site Monitoring

Our staff members have extensive experience conducting site visits to monitor protocol compliance, train personnel, and provide implementation support. Clinical monitoring typically uses both field-monitoring staff and in-house monitoring staff to optimize efficiencies while reducing data discrepancies. Protocol processes, including enrollment practices, data collection, and pharmacy and laboratory procedures, are all assessed over the course of the visit. Site regulatory documents also are reviewed, including required clinical manuals, standard operating procedures, protocols, manuals of operations, completed 1572 forms, and signed informed consent forms.