The Office of Research and Sponsored Programs is dedicated to advancing high quality clinical trial research in accordance NuHealth’s educational, research, clinical care and community service mission. ORSP is responsible for the administrative, regulatory, and institutional requirements to establish and conduct clinical research at NuHealth supported through contracts with private industry sponsors, as well as other entities.
ORSP provides the infrastructure and resources required to support patient-based research for the NuHealth. ORSP serves as a central resource for NuHealth faculty, staff and departments involved in clinical trials research and for sponsors seeking to conduct clinical trials at NuHealth by:
- Serving as the point of contact for questions or issues related to clinical trials
- Negotiating, reviewing and approving contracts, agreements and documents required to establish and conduct clinical trials supported by private industry and other entities
- Provide assistance and consultation in budget development and preparation
- Developing and providing education and training on the requirements and procedures related to the conduct of clinical research
- Serving as an expert resource for information on the issues and requirements for the conduct of clinical research
- Interacting and communicating with sponsors, and other entities on behalf of the institution, researchers and departments on issues related to clinical trials
- Developing and implementing programs and initiatives, based on monitoring and assessment, to enhance the quality of clinical research and support regulatory compliance
- Providing oversight for the clinical trials.
Investigators, staff and departments are not authorized to sign agreements on behalf of the Institution. ORSP has been delegated signature authority on behalf of the institution to sign agreements related to clinical research.
Industry-sponsored clinical trials
Please see Clinical Trial Process diagram for the guidance for study initiation.
Definition of Terms:
Confidential Disclosure Agreement (CDA) – sometimes called a “Confidentiality Agreement” or “Non-Disclosure Agreement,” is a legal document which ensures the confidentiality or “secrecy” of information that one party discloses to another party. A signed CDA may be required before an industry sponsor agrees to disclose its proprietary information (e.g., the study protocol) to an investigator. ORSP is responsible for reviewing CDAs related to the evaluation of industry-supported clinical research studies conducted at the Medical Center.
A Clinical Trial Agreement (CTA) – is a contract between the NuHealth and the Sponsor of a clinical trial. A CTA defines the scope of work and formalizes the understandings between the parties and contains legal and financial terms related to the conduct of a clinical trial.
1572 form – is an FDA form in which the investigator states that s/he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting.