The Office of Clinical Research's (OCR) mission is to support the highest quality program of clinical research at Memorial Sloan-Kettering through central management, standarized practice and oversight to our clinical research programs. The OCR strives to ensure that clinical research policies and procedures adhere to existing research standards as well as federal regulations.
The OCR is comprised of six divisions; each division has the overall goal of the Core Facility and its mission plus distinct functions and responsibilities relating to the Center's clinical research activities.
Protocol Development Office
Provides oversight and guidance to the institutional protocol development review and approval process and provides training and guidance on protocol development to ensure adherence to institutional standards and federal regulatory requirements; responsible for the management of the Research Council and several institutional committees relating to protocol development and approval (e.g., IND Committee, Human Biospecimen Utilization Committee).
Office of Research Management
Provides oversight for the clinical research organizational and management structure at MSKCC. Serves as a resource and collaborates with all clinical departments, regional network centers, MSK partnerships and affiliates, clinical investigators and research support staff. Develops, implements and monitors research standards and ensures that good clinical practice (GCP) guidelines and governmental regulations are followed throughout the Center.
Data Management Resource
Provides the technical expertise to the research staff and clinical investigators regarding their data and protocol management needs. They participate in the relational database design, implementation and maintenance of the CRDB (Clinical Research Database) and the Protocol Information Management System (PIMS).
Clinical Research Quality Assurance
Ensures that the Center's staff adheres to the federal regulatory requirements of cGCP through the development, implementation and monitoring of research policies, as well as the direct oversight of the clinical research programs. CR QA staff manage three institutional committees: Therapeutic Response Review, Data and Safety Monitoring Committee and Data and Safety Monitoring Board, which serve to monitor the Center's research studies.
Manufacturing Quality Assurance
Provides guidance and assistance on quality and regulatory issues for MSKCC investigators developing and manufacturing investigational drugs and other therapies. Ensures that the Center's laboratories adhere to the federal regulatory requirements of cGMP and cGTP through the development, implementation, and monitoring of Standard Operating Procedures and Good Manufacturing Practices training programs.
Office of the Institutional Review Board/Privacy Board
Responsible for the administrative and operational management of the human subjects research protection body, the IRB/PB. Manages the daily operational activities of the IRB Chairman and the IRB Committee; ensures compliance with 45 CFR 46 and all guidances set forth by the Office of Human Research Protection.
