Negotiating a Contract
The purpose of the clinical trial agreement (CTA) or contract is to set forth and manage the responsibilities and relationships between the sponsor, site, and/or the institution for the conduct of the clinical research trial. Responsibilities of the site include maintaining staff certifications and documentation, agreeing to follow the details of the protocol, obtaining appropriate subject consent, and providing all needed documents to the institutional review boards (IRB). The contract sets out the specifics of the compensation and schedule of payments. Other clauses address the investigational product, use of equipment, and audit procedures.
KeywordsContact Master agreement Unlawful inducements Kickback Protocol Hold back Physician payments sunshine act Inclusion criteria Exclusion criteria Investigational product Audit Confidentiality Termination Indemnification
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