This document discusses audits and inspections in clinical trials. It defines an audit as an independent examination of trial activities and documents to determine compliance, while an inspection is an official review by a regulatory authority. The purpose of a sponsor's audit is to evaluate trial conduct and compliance with quality systems, the protocol, GCP, and regulations. Audits examine organizations, personnel, quality management, investigational products, IRBs/ECs, investigators, essential documents, and computerized systems. Inspections are regulatory reviews of documents, facilities, and records related to the trial located at sites, sponsor/CRO facilities, and other establishments.
This document discusses audits and inspections in clinical trials. It defines an audit as an independent examination of trial activities and documents to determine compliance, while an inspection is an official review by a regulatory authority. The purpose of a sponsor's audit is to evaluate trial conduct and compliance with quality systems, the protocol, GCP, and regulations. Audits examine organizations, personnel, quality management, investigational products, IRBs/ECs, investigators, essential documents, and computerized systems. Inspections are regulatory reviews of documents, facilities, and records related to the trial located at sites, sponsor/CRO facilities, and other establishments.
This document discusses audits and inspections in clinical trials. It defines an audit as an independent examination of trial activities and documents to determine compliance, while an inspection is an official review by a regulatory authority. The purpose of a sponsor's audit is to evaluate trial conduct and compliance with quality systems, the protocol, GCP, and regulations. Audits examine organizations, personnel, quality management, investigational products, IRBs/ECs, investigators, essential documents, and computerized systems. Inspections are regulatory reviews of documents, facilities, and records related to the trial located at sites, sponsor/CRO facilities, and other establishments.
Trial OBJECTIVE WHAT IS AUDIT PURPOSE OF AUDIT WHAT IS INSPECTION DIFFERENCES BETWEEN AUDIT AND INSPECTION WHO IS RESPONSIBLE FOR AUDIT AND INSPECTION TYPES OF AUDIT AND INSPECTION REASON FOR AUDIT AND INSPECTION WHEN AND WHAT GET AUDITED AUDIT PROCEDURES RULE PREPRATION FOR AUDIT What is Audit A Systematic and independent examination of trial related activities and documents to determine. • Whether the evaluated trial related activities were conducted and • The data were recorded, analyzed and accurately reported according to the Protocol, sponsor sop’s, GCP, and Applicable regulatory requirements. • (ICH-GCP Sec. 1.6) Purpose of Audit The purpose of a sponsor’s audit is to evaluate the trial conduct and compliance with:- • Quality Systems and SOPs Protocol • Good clinical practices & other applicable regulatory requirements • Auditors are independent of the clinical trial/ data collection system(s), Sponsor or CRO or Site What to Audit Organization and personnel Responsibilities and functions - Ensure clear responsibilities exist so as to minimize ambiguity between:- Investigator and sub-investigator Sponsors and contractors Contractors/suppliers (CROs, Labs, IRBs) – audit suppliers • Qualification, training and adequacy of staff List of monitors • List of all investigators What to audit Quality management systems Management responsibilities Procedures and their adequacy Training Documentation control Deviations and non conformities management QC, QA Internal Monitoring Program Internal Auditing Program Investigational drug •Manufacturing, packaging, labeling and coding of the investigational product (including placebo and active comparator where applicable) in accordance with applicable GMP standards
• Labeling requirements, “For Clinical Trial Use Only” to protect blinding
where applicable • Drug Product Accountability Control Quantity Continued… What to Audit IRB/EC – Responsibilities – Composition, functions and operations – Procedures – Records Investigators and sub-investigators – Qualifications and agreements Essential documents Computerized systems (used to create, modify, maintain, archive, retrieve or transmit data): Identify software and hardware used, when and where? Check security of the system (individual Login, secure passwords) Check traceability Check audit trail capabilities where applicable:- What is Inspection Inspection “The act by a regulatory of conducting and official review of documents, facilities, records, and any other resources that are deemed by the authority to be related to the clinical trial and that may be located at thee Site of the trial, Sponsor’s and/or CRO’s facilities, Other establishments deemed appropriate by the regulatory authority. (ICH-GCP Sec 1.29) Steps in FDA Inspection Process FDAOffice Site Location Types of studies Difference between Audit