Contracts
To avoid confusion or inconsistency, it is advisable that the contract between the Sponsor and the contractor is restricted to commercial considerations and should not overlap with the technical content of the study plan.
The OECD Principles of Good Laboratory Practice require that:
- The name and address of the Sponsor be provided in the study plan and in the final report
- The study plan be signed and dated by the Sponsor if required by national regulation or legislation in the country where the study is being performed.
- Notwithstanding any contractual agreements for confidentiality, national Good Laboratory Practice monitoring authorities have the right of access to all the data produced by the test facility.
