In a final report submitted to FDA or EPA, what must be done with the reports of contributing scientists?

• A. Must be appended to the sponsor's final report and the original version archived
• B. Submitted as separate documents
• C. Included in a separate appendix not linked
• D. Sent directly to the FDA without attachment

Answer: (A)

In GLP-style regulatory reporting, the input from contributing scientists is treated as part of the sponsor’s submission rather than as separate, standalone files. The best practice is to append those reports to the sponsor’s final report so reviewers see all contributions in one coherent document, and to archive the original versions for the official record. This preserves a clear, auditable link between each scientist’s work and the overall study, and ensures the submission remains complete and traceable for inspections. Other approaches—keeping reports as separate documents, placing them in a non-linked appendix, or sending materials to the agency without attaching them to the sponsor’s final report—would fragment the submission, create ambiguity about how the reports relate to the study, and undermine the audit trail.