Questions and Answers
What is an inspection according to ICH E6?
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.
What will FDA inspectors do during an inspection?
Review regulatory records.
What is the overall goal of monitoring, audits, and inspection activities?
Ensure the protection of human research subjects and data integrity.
How is an 'audit' defined according to ICH E6?
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What is OHRP primarily concerned with?
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Study Notes
Inspections and Audits in Clinical Trials
- An inspection is an official review of documents, facilities, records, and resources related to a clinical trial, conducted by regulatory authorities.
- Audits refer to systematic and independent examinations of trial-related activities and documents.
- Monitoring involves overseeing the progress of a clinical trial to ensure compliance and integrity.
FDA Inspection Process
- During inspections, FDA inspectors review regulatory records to assess compliance with applicable laws and regulations.
Goals of Monitoring, Audits, and Inspections
- The primary goal is to ensure the protection of human research subjects and maintain data integrity throughout the clinical trial process.
Definition of an Audit
- An audit is defined as a systematic and independent examination of trial-related activities and documents, aimed at evaluating compliance and quality.
Role of OHRP
- The Office for Human Research Protections (OHRP) is responsible for overseeing the protection of human research subjects, ensuring ethical standards are met in clinical trials.
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Description
This quiz covers essential terminology and concepts related to audits and inspections of clinical trials as defined by ICH E6. Understand the differences between inspections, audits, and monitoring in the context of clinical research. Perfect for students and professionals involved in clinical trials.
