Audits And Inspections Of Clinical Trials

An inspection is defined as the act by a regulatory authority of conducting an official review of documents, facilities, records, and any other resources related to a clinical trial. A systematic and independent examination of trial-related activities and documents is "an audit" and the act of overseeing the progress of a clinical trial is "monitoring."
Explanation: An inspection is defined as an activity that is conducted to verify, by examination and/or testing, the status of a process, a product, a system, or an activity, and to determine whether it conforms to requirements.

Review regulatory records.
Explanation: The FDA conducts inspections to ensure that food manufacturers are following proper food safety procedures. The inspectors will look for evidence of contamination, proper food handling procedures, and proper sanitation procedures. They will also take samples of food for testing.

Ensure the protection of human research subjects and data integrity.
Explanation: The overall goal of monitoring, audits, and inspection activities is to ensure that an organization is adhering to its internal policies and procedures and to external regulations. By conducting these activities on a regular basis, organizations can identify areas where improvements need to be made in order to reduce the risk of non-compliance.

A systematic and independent examination of trial-related activities and documents.
Explanation: An audit is a systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled.An audit should be conducted in a manner that ensures that the evidence is credible and that the conclusions are valid. An audit should be conducted by one or more persons who have the necessary skills, knowledge and experience to perform the audit.The purpose of an audit is to provide assurance that the systems, processes and controls in place are adequate and effective, and that the organization is complying with applicable laws and regulations.An audit is not a substitute for management's responsibility to establish and maintain adequate and effective systems, processes and controls. Nor is an audit a guarantee that all compliance deficiencies will be identified.

Protection of human research subjects
Explanation: The Office for Human Research Protections (OHRP) is an oversight body within the U.S. Department of Health and Human Services. OHRP's primary concern is with the protection of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services.