Where should essential documents be located?

Where should essential documents be located?

• A. Only at the sponsor's office
• B. Only at the investigator's site
• C. At both the investigator/institution and sponsor locations
• D. With regulatory authorities

Answer: (C)

Essential documents must be accessible and securely maintained at both the investigator’s site and the sponsor’s location. This dual placement supports ongoing monitoring, auditing, and inspections by regulators, while ensuring that both the investigator and sponsor can review, verify, and confirm the trial’s conduct and data integrity. Keeping documents only at one site or only with authorities would hinder oversight and accountability and could delay or complicate inspections or verifications. Regulatory authorities may inspect and request access, but the primary, ongoing storage should be at both the investigator/institution and sponsor locations.

Essential documents must be accessible and securely maintained at both the investigator’s site and the sponsor’s location. This dual placement supports ongoing monitoring, auditing, and inspections by regulators, while ensuring that both the investigator and sponsor can review, verify, and confirm the trial’s conduct and data integrity. Keeping documents only at one site or only with authorities would hinder oversight and accountability and could delay or complicate inspections or verifications. Regulatory authorities may inspect and request access, but the primary, ongoing storage should be at both the investigator/institution and sponsor locations.