Clinical Research Support Office/CRSO
The mission of the Clinical Research Support Office (CRSO) in the CTSA is to provide comprehensive, coordinated resources, education, and services to scientists, physicians, investigative teams, research staff, support staff, and human research participants, in a manner that is thorough, consistent, efficient, compassionate to participants, and integrated across the entire research enterprise so that research is conducted to the highest standards of safety and ethics, and at the highest standards of scientific design and integrity.
The Regulatory Knowledge and Support Key Function of the Rockefeller University Center will be served by the Clinical Research Support Office (CRSO), offering a broad range of services, policies, direct assistance, education, advocacy, resources, and tools for members of the research community and research participants. Under the leadership of Dr. Rhonda Kost, key function director and Clinical Research Officer (CRO), the staff consists of: 1) two Clinical Research Specialists with experience as research coordinators and good clinical practice (GCP) trainers, 2) an IND Specialist Monitor with experience in clinical research auditing/monitoring, including IND related protocols 3) an Associate Auditor/Monitor, 4) two Recruitment and Outreach staff members, and 5) individuals to provide clerical support.
The Clinical Research Officer will coordinate the policies, personnel, and activities of the CRSO with the Participant and Clinical Initiatives Resources (PCIR), and with Hospital Information Services, the Office of Regulatory Affairs, and the IRB with regard to human subject protections and ethics, quality assurance, oversight, and compliance.
The CRSO is operationally linked to the BioInformatics Department and the fulfillment of the Hospital Information Technology (IT) Strategic Plan, on which the Clinical Research Officer has collaborated from its conception. This collaboration is crucial as the promise of data integration, transparency, and workflow assistance integral to the IT Plan are crucial to the dissemination of commonly utilized protocol information, critical regulatory and safety information, the reduction of duplication of effort, and the removal of obstacles to the conduct of translational clinical research, all of which are critical to the success of the clinical research enterprise.
GoalsThe goals of the Clinical Research Support Office bridge four interrelated areas:
Operations, Functions and Services
- Support for and Knowledge of Regulatory Activities
- Protocol, Informed Consent, Data and Safety Monitoring Plans, and IRB Liaison Services: The Clinical Research Support Office provides support for the regulatory activities required for the successful conduct of translational and clinical research conducted at Rockefeller University Hospital (RUH) through coordination and integration of staff resources and policies via a centralized office, assisting investigators, teams, and staff in the following areas:
- Protocol and Informed Consent Authoring and Translation
- Data and Safety Monitoring Plan (DSMP) development and implementation
- Providing an independent Liaison to the IRB
- Support in achieving Patient Safety and Regulatory Management and Compliance: DSMP oversight
- Elements of Good Clinical Practice and Compliance
- Monitoring and Auditing
- Development of innovative assessment tools for outcomes-based research to identify targets for performance improvement and institutional best practices are underway.
- Human Research Participant Advocacy
The role of the Research Subject Advocate is to champion the mission of the safe and ethical conduct of research through all the activities of the Hospital and Center. Center resources allow for significant expansion in the scope and execution of Human Research Participant Advocacy by the Clinical Research Support Office.
- Reduction And Removal Of Institutional Impediments
The third goal of the CRSO is to reduce or remove institutional impediments to clinical and translational research. The Clinical Research Support Office is operationally linked to the Informatics Department and the fulfillment of the Center Information Technology (IT) Strategic Plan, on which the Clinical Research Officer has collaborated from its conception. This collaboration is crucial as the promise of data integration, transparency, and workflow assistance integral to the IT Plan are crucial to the dissemination of commonly utilized protocol information, critical regulatory and safety information, the reduction of duplication of effort, and the removal of obstacles to the conduct of translational clinical research, all of which are critical to the success of the clinical research enterprise. The following link summarizes the Interactive Elements of Good Clinical Practice (GCP) Within The Rockefeller University Center for Clinical and Translational Science.
- Strategies and Tools for Sharing Best Practices in Regulatory Support and Advocacy
The Rockefeller University Center for Clinical and Translational Research is committed to sharing and adopting Best Practices in collaboration with the National CTSA Consortium Steering Committee. A Proposal to develop the Picker Clinical Research Perception of care Survey as a validated tool to benchmark outcomes of Clinical Research Regulatory Support, Education, Research Subject Safety and other programs across the CTSAs is in its pilot stage of development. Project pilot and outcome data will be submitted to the National CTSA Consortium Steering Committee Initiative for consideration as it becomes available.