To document that there are written agreements among involved parties, which location is used?

• A. Sponsor
• B. Investigator/Institution when involved
• C. Both Sponsor and Investigator/Institution when involved
• D. Regulatory Authorities

Answer: (C)

Written agreements between the sponsor and the investigator or institution must be available to both parties, and kept in the records of each side. In practice, the clinical trial agreement is stored in the sponsor’s trial documentation and in the investigator’s/institution’s regulatory file. This dual location confirms that all parties have a defined understanding of duties, responsibilities, and obligations, and it supports audit readiness and compliance. While regulators can request to review these agreements during inspections, the primary repositories are the sponsor’s and the site’s files.