Which term is a written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters?

Which term is a written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters?

• A. Case Report Form (CRF)
• B. CRO
• C. Contract
• D. Coordinating Committee

Answer: (C)

A contract is the written, dated, and signed agreement that sets out who is responsible for which tasks, how those tasks are distributed, and any financial terms. In clinical research, this instrument formalizes the relationships among sponsor, investigators, and service providers, clarifying duties, timelines, accountability, and payments to ensure everyone knows their obligations and regulatory expectations are met. A Case Report Form is just a data collection tool, not an agreement about roles or money. A CRO refers to a service provider organization, not the binding agreement itself. A Coordinating Committee is a governance group for oversight, not the document that defines task delegation and financial arrangements. Therefore, the term is contract.

A contract is the written, dated, and signed agreement that sets out who is responsible for which tasks, how those tasks are distributed, and any financial terms. In clinical research, this instrument formalizes the relationships among sponsor, investigators, and service providers, clarifying duties, timelines, accountability, and payments to ensure everyone knows their obligations and regulatory expectations are met. A Case Report Form is just a data collection tool, not an agreement about roles or money. A CRO refers to a service provider organization, not the binding agreement itself. A Coordinating Committee is a governance group for oversight, not the document that defines task delegation and financial arrangements. Therefore, the term is contract.