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How to OCR Clinical Trial Agreement

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What is included in a clinical trial agreement?

A clinical trials agreement should describe and acknowledge responsibilities, terms of collaboration, requirements for payment and reimbursement, publication and intellectual property terms, indemnification and or insurance, subject injury coverage, guidelines for dispute resolution, grounds for termination of contract

What are the components of a clinical trial agreement?

Clinical Trial Agreement (CTA) Description of the Project. Sponsor, CRO (Contract Research Organization) and Site Responsibilities. Publication and Intellectual Property Terms. Indemnification and Insurance.

What is a CTA agreement?

Contractor Team Arrangement means a Federal Supply Schedule Contractor Team Arrangement (CTA) where an arrangement is established between two or more Schedule contractors who work together to meet agency requirements.

How do you write a clinical trial agreement?

9 Essential Components of a Clinical Trial Agreement Description of the Project. Payment Terms and Schedule. Sponsor, CRO and Site Responsibilities. Publication and Intellectual Property (IP) Terms. Indemnification and Insurance. Recordkeeping and Inspection. Guidelines for Dispute Resolution. Grounds for Contract Termination.

What is an investigator Source agreement?

This is a formal written agreement between an institution conducting research and an independent investigator who is collaborating on the research, by which the institution agrees to extend its Federalwide Assurance (FWA) about human subjects research to the individual, and by which the independent investigator agrees

What is OCR in clinical trials?

Office of Clinical Research (OCR)

Who are the parties to a CTA?

A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each partys responsibilities and obligations for the clinical trial.

What is the purpose of a clinical trial agreement?

CTAs are one of several key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each partys responsibilities and obligations for the clinical trial.

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OCR Clinical Trial Agreement