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Clinical Trial Sign Off Form Industry Sponsor - University of Rochester

Clinical Trial Sign Off Form Industry Sponsor - University of Rochester 2025

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The document is a Proposal Sign-Off Form for the University of Rochester, which must be completed and submitted with research proposals to the Office of Research and Project Administration (ORPA). It includes sections for principal investigators to provide project details, administrative considerations, required signatures from department chairs and deans, and certifications regarding compliance with university policies and federal regulations. The form ensures that all necessary approvals are obtained before submitting a proposal for funding.

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What is the difference between a sponsor and an investigator in clinical trials?

In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Sub-investigator includes any other individual member of that team (21 CFR 321.3). Sponsor means a person who takes responsibility for and initiates a clinical investigation (21 CFR 312.3).

What is the difference between a CRO and a sponsor in clinical trials?

For starters, a Sponsor is exactly what it sounds like they sponsor the clinical research study. A Sponsor may or may not choose to use a CRO, which is a clinical research organization or contract research organization. Basically, a CRO is the middle man between the Sponsor and the research sites.

Who is the sponsor in a clinical trial?

More Info. A sponsor in clinical research is a person or group that is responsible for the design, conduct, and oversight of a research study.

What are the responsibilities of the sponsor?

A project sponsor has three main responsibilities: Vision and people: Aligning the project with business goals, strategy, and objectives. Governance: Ensuring the projects proper launch and execution. Value and benefits: Managing risks and changes while ensuring the projects quality.

What is the sponsor of a clinical trial?

A clinical study sponsor refers to an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study or trial. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.