GXP Solutions | Good Clinical Practice (GCP)

What is a Good Clinical Practice (GCP) audit?

A GCP audit is a systematic and independent examination of clinical trial activities and documents. As per the International Council for Harmonization (ICH), GCP is an international ethical and scientific quality standard for designing, conducting, recording, and analyzing clinical trials. Compliance with GCP guidelines is critical for obtaining reliable and valid data, protecting the rights of study participants, ensuring human subject protection, and supporting the integrity of research.

GCP audits are conducted to assess compliance with regulatory and approved protocol requirements. With a focus on the integrity of the process and the compliance of the site with all aspects of the protocol.

Purpose of GCP Auditing

Good Clinical Practice (GCP) auditing plays a crucial role in maintaining compliance with clinical trial regulations. It involves systematic and independent examination of all processes related to the conduct of clinical trials. The primary purpose of GCP auditing is to identify areas of non-compliance and recommend corrective actions to improve the overall quality of clinical research.

Site Audits

Sponsor Audits
Investigator Site Audits (e.g., Phase I, II & III)
Investigational Review Boards (IRBs) Audits
Non-Interventional Clinical Study Audits
Trial Master Files (TMF) Audits
Investigator Site Files / Regulatory Binder Audits

Vendor Audits

Full Service CRO
Site Management Organization (SMO)
Safety Reporting
Medical Writing
Site Management
Central / Clinical / Diagnostic Laboratory / IMP & Specimen Storage
PK/PD/Bioanalytical Laboratory
Interactive Response Technologies (IRTs)
- Interactive Web Response Systems (IWRS)
- Interactive Voice Response Systems (IVRS)
Archiving / Documents Storage
Translation Services

Document Audits

Trial Master Files Audit
Clinical Trial Report
Common Technical Document
Trial Master Files
Protocol/Amendments
Informed Consent
Investigator’s Brochure
Case Report Forms
Data Management Plan
Data Protection/Privacy

System and Process Audits

Clinical Study Team Formation and Operational Planning
Training
Investigational Brochure Development
Electronic submission audits
Clinical operations and monitoring
Data entry and data management
Statistical Analysis Plan Development and Approval
Study Blinding Unblinding
Risk Management Planning and Development
TMF Management
Medical writing departments.
QA In-Process Audits
- Staff updated training records.
- Appropriate protection of subject information
- Consent process completion
- Source document completion and review
- CRF review to minimize correction of induced data entry errors.
- Assurance of ongoing equipment calibration and maintenance
- Proper handling of investigative products, Documentation addressing accountability, Dispensing,
- Awareness of any protocol or study changes based on shared data with investigators.
- Facilities and Equipment,
- Documentation of laboratory inspections
- Records of temperature logs and temperature excursions

Inspection Readiness and Mock Inspection

Investigator site audits (e.g., Phase I, II & III)
Non-Interventional Clinical Studies
Investigation of fraud and misconduct
For Cause / Serious Breach Audits
CAPA Management
Risk Assessments
Gap Analysis
QMS Projects

Importance of GCP Auditing

GCP auditing is crucial for ensuring the integrity and reliability of clinical trial data. It helps to identify any issues or discrepancies that may compromise the safety and rights of study participants, as well as the validity of research outcomes. By conducting regular audits, sponsors and CROs can proactively address any areas of non-compliance and ensure the protection of human subjects involved in clinical research.

Protecting the Rights of Study Participants

One of the primary responsibilities of GCP auditing is to protect the rights and well-being of study participants. This includes ensuring that informed consent has been obtained from all participants, their privacy and confidentiality are maintained, and any potential risks associated with participation have been properly disclosed and managed.

Ensuring Data Accuracy and Reliability

GCP auditing plays a crucial role in ensuring the accuracy and reliability of clinical trial data. By assessing the quality of data collection, storage, and analysis processes, auditors can identify any discrepancies or errors that may impact the validity of research outcomes. This is especially important for trials involving new drugs or medical devices, where data accuracy is critical for determining their safety and efficacy.