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 therapeutic products and Class 2 cell, tissue or gene therapy products (CTGTPs) 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)

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 types of inspections are to:

Safeguard the rights, safety and well-being of trial participants
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

During a GCP Inspection	Details
Opening meeting	GCP 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 in relation to the inspection scope. This may include information pertaining to trial participant recruitment, informed consent process, investigational product management, safety reporting, biological sample handling, etc.
Interviews with study staff	Interviews will be conducted with key study staff to determine how the clinical trial is being conducted.
Visit to facilities	GCP inspectors may visit the site or facilities where the trial is conducted.
Document review	Essential documents will be reviewed.
Interim meeting	Observations from the GCP Inspection may be shared to provide the inspectee with an opportunity to clarify or resolve the observations during the GCP Inspection, where possible.
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.

Remote / Hybrid GCP Inspections

Based on the experience gained from the COVID-19 pandemic, remote / hybrid approaches to GCP inspections may be incorporated into regular GCP inspections where appropriate and feasible, based on the inspection scope and if the objectives of GCP Inspection will not be compromised.

Refer to the Guidance on GCP Compliance Inspection Framework301 KB for more details on the GCP Inspection.

Presentations - ICH E6 (R3) GCP Guideline

DATE	PRESENTATION
1 Aug 2023	ICH E6 (R3) GCP Guideline - Overview of Step 3 Draft810 KB Presented in HSA-SCRI Public Webinar on Draft ICH E6 (R3) Guideline (Click here to view recording)

DATE

PRESENTATION

1 Aug 2023

ICH E6 (R3) GCP Guideline - Overview of Step 3 Draft810 KB

Presented in HSA-SCRI Public Webinar on Draft ICH E6 (R3) Guideline
(Click here to view recording)

Presentations - Common GCP Inspection Findings

DATE	PRESENTATION
26 Jan 2024	Looking Back at 2023991 KB Presented in CRCS Forum
6 Jan 2023	Looking Back at 2022594 KB Presented in CRCS Forum
20 Jan 2022	Looking Back at 2020-2021906 KB Presented in CRCS Forum
3 Dec 2019	Looking Back at 2019475 KB Presented in CRCS Forum
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

Last updated: 31 Dec 2018