What does the contract nonclinical laboratory provide to the sponsor?

• A. Raw data and its study file
• B. Final report
• C. A complete regulatory package
• D. A safety assessment

Answer: (A)

Under GLP, the most important deliverable from a contract nonclinical laboratory to the sponsor is the raw data along with the study file. This combination provides a complete, auditable record of what was done and what was observed: the raw data show exactly what measurements or observations were made, while the study file documents the protocol, any amendments, deviations, equipment used, personnel, and QA checks. This traceability is essential for independent verification, data integrity, and regulatory review.

The final report is produced from these data and the file, but it alone does not establish how results were obtained or allow independent verification without the underlying records. Other options like a complete regulatory package or a safety assessment are not the standard standalone deliverables from the contract lab; they’re broader outputs that typically depend on, and are assembled from, the raw data and the study file by the sponsor or regulatory bodies.