Good Clinical Practice Inspections

Understand the processes for preparation, conduct and follow up of Good Clinical Practice Inspections. 

Overview

A Good Clinical Practice (GCP) Inspection is an official review of documents, facilities, records and any other resources that are related to your clinical trial. The inspection may be done at the site of the trial, the sponsor's or contract research organisation's facilities or at another appropriate location. The inspection may also take place at multiple sites where required.

The following types of clinical trials may be subjected to GCP Inspections:

  • Clinical trials of pharmaceutical drugs that are subject to the requirements of a Clinical Trial Authorisation (CTA) or Clinical Trial Notification (CTN).
  • Clinical trials of medicinal products that are subject to the requirements of a Clinical Trial Certificate (CTC).

Note: The inspectee of a GCP Inspection may either be the Principal Investigator or the sponsor of the clinical trial being inspected.

Objectives of GCP Inspections

GCP inspections may either be protocol-specific or systems. The objectives of both these types of inspections are to:

  • Safeguard the rights, safety and well-being of trial subjects.
  • Verify the quality and integrity of clinical trial data submitted to the regulatory authorities.
  • Assess compliance to protocol, applicable regulations, guidelines and standard operating procedures.

Additionally, the objectives of systems inspections are to:

  • Assess whether a system is suitably designed, controlled, maintained and documented to fulfil intended objectives.
  • Identify areas for quality improvement.

Types of GCP Inspections

Type Description
Routine Usually apply to ongoing clinical trials and are done announced.
Triggered Conducted as a result of requests, complaints or reports to us on suspected violations of regulations. Such types of inspections may be done announced and apply to ongoing or completed clinical trials.
Pre-marketing approval application Usually apply to completed clinical trials and are done announced.

GCP Inspection process

Components during a GCP Inspection Details
Opening meeting Compliance inspectors will explain the GCP Inspection framework, confirm the agenda and confirm that all resources, documents and facilities required for inspection are available.

The inspectee will present an overview of the clinical trial. This includes information pertaining to subject recruitment, informed consent process, investigational product management, safety reporting and biological sample handling.
Interviews with study staff Interviews will be conducted with key study staff to determine how the clinical trial is being conducted.

Visit to site facilities Compliance inspectors may visit the site or facilities where the trial is being conducted.
Document review Essential documents will be reviewed.
Closing meeting Observations from the GCP Inspection will be shared.

Grading of GCP Inspection Findings

GCP Inspection Findings will be graded based on the impact on the goals of GCP, frequency of occurrence, and corrective and preventive actions that can be taken.

Grading Impact on the goals of GCP
Critical Adversely affects
Major Might adversely affect
Other Not expected to adversely affect
Comments The observations might lead to suggestions on how to improve quality or reduce the potential for a non-compliance to occur in the future.

Refer to the Guidance on GCP Compliance Inspection Framework345 KB for more details on the GCP Inspection criteria. 

Presentations - Common GCP Inspection Findings

DATE PRESENTATION
7 Dec 2018

Common GCP Inspection Findings in 2018428 KB

Presented in CRCS Forum

1 Dec 2017

Common GCP Inspection Findings in 2017595 KB

Presented in Combined CRP-CRCS Forum

16 Jan 2017 Common GCP Inspection Findings in 2016309 KB
3 Dec 2015

Common GCP Inspection Findings in 2015498 KB

Presented in Combined CRP-CRCS Forum

12 Dec 2014

Common GCP Inspection Findings in 20141082 KB

Presented in Combined CRP-CRCS Forum

13 Nov 2013

Common GCP Inspection Findings in 2013902 KB

Presented in Combined CRP-CRCS Forum

2012 Common GCP Inspection Findings in 20121591 KB
2011

Common GCP Inspection Findings in 2011881 KB

Case Studies from GCP Inspections in 20112206 KB

2010 Common GCP Inspection Findings in 2010738 KB
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