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Audits & Inspections PDF

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.

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316 views13 pages

Audits & Inspections PDF

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.

Uploaded by

shirisha chowdary
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Presented by : Razia Begum

Audit and Inspection in Clinical


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

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