Office of Human Research Services

Director: Tracie K. Saunders, RN, MS

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The Office of Human Research Services (OHRS) provides centralized support to Cancer Institute investigators through management and oversight functions for the development, implementation, coordination, and reporting of human research trials and results.  The OHRS provides a broad range of management and quality control services, including trial development, activation, eligibility verification, monitoring, centralized protocol document directory and database of protocol-specific data, data and safety reporting, and assistance with regulatory issues.

Office of Human Research ServicesThe Specific Goals of this Shared Resource are to:

  • To assist investigators in protocol development, as needed, and facilitate institutional approval, implementation, and conduct of clinical trials
  • To maintain a centralized web-based repository of protocols, consent forms, and other protocol specific documents
  • To facilitate the conduct of clinical trials (institutional and multi-center) via centralized clinical trial infrastructure, including but not limited to enrollment and verification of patient eligibility, scheduling of appropriate tests, treatments, and assessment
  • To provide electronic data capture, data management and verification, and data submission to NCI and other sponsors
  • To ensure that all reports, including reports of serious adverse events, are submitted in accordance with institutional and federal regulatory guidelines to appropriate regulatory bodies, including the IRB and sponsors
  • To ensure protocol compliance, data accuracy and data integrity through a system of monitoring and quality assurance that is consistent with the Data and Safety Monitoring Plan (DSMP)