NIA CLINICAL TRIALS OPERATIONS SUPPORT CENTER

Kai Research, Inc, Rockville MD

Investigators

Abstract

The objectives of this contract are to continue operation of the CTOSC in order to provide support for the management, tracking, and oversight of clinical trials funded by the NIA. This clinical trial support includes providing technical and administrative assistance to investigators in the areas of quality assurance and safety. The contractor will provide clinical trial support in the interpretation and implementation of quality assurance guidelines for specific clinical studies; maintenance of the NIA Clinical Research Study Investigator's Toolbox, a web based informational resource for researchers ensuring data quality and integrity; training to the Principal Investigator (PI) and staff on how to perform an internal audit or other study monitoring activities; maintenance of the NIA Safety Training Course; review of the awardees? clinical trial materials and reports to ensure participants? safety and alert the NIA?s program staff about emerging safety concerns with studies, as well as recommend possible corrective actions to eliminate or decrease risks to study participants.