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
|| Usually apply to ongoing clinical trials and are done announced.
|| 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
| 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.
|| Impact on the goals of GCP
|| Adversely affects
|| Might adversely affect
|| Not expected to adversely affect
|| 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.