Contract is a formal and legally binding agreement between entities involved in clinical trials, such as sponsors, contract research organizations (CROs), or research sites. These agreements ensure clarity, protect the interests of all parties, and provide a framework for the execution of clinical research projects. Contracts might outline the:
- terms and conditions governing the collaboration,
- confidentiality,
- project scope,
- responsibilities,
- financial arrangements,
- data sharing, etc.
Definitions
ICH E6(R2)
ICH E6 1.17 Contract:
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. The protocol may serve as the basis of a contract. [1].
See also
Links to this page
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf