What documentation certifies the identity, purity, and strength of investigational products to be used in the trial?

• A. Certificates of Analysis for New Batches of Investigational Products
• B. Source Documents
• C. Monitoring Visit Reports
• D. Signed Informed Consent Forms

Answer: (A)

Certifications of Analysis are the documents that verify a batch of investigational product meets the required specifications for identity, purity, and strength. Issued by the sponsor or the manufacturer, a COA confirms that the product is indeed what it is supposed to be (identity), that its impurities are within acceptable limits (purity), and that its potency or assay result matches the labeled strength. A COA typically includes the batch or lot number, manufacturing date, expiry, test methods, acceptance criteria, and the actual results. This documentation is essential before releasing any product for use in a trial to ensure consistency, safety, and regulatory compliance, and it supports traceability of each batch used in the study. By contrast, source documents capture trial data from participants, monitoring visit reports summarize site monitoring findings, and signed informed consent forms document participants’ consent—not product quality.