GCP Auditor Online Course Programme
Please note that timings are flexible, as this is a self-paced online course. You can study at your own convenience and complete the course at your preferred pace.
Course Overview
This course provides comprehensive training for becoming a GCP (Good Clinical Practice) Auditor. Upon completion, participants will receive a GCP Auditor certification. The course is designed for flexible online learning, allowing participants to progress at their own pace.
Course Content
1. Introduction and Objectives
An overview of the course objectives, including the importance of GCP auditing in clinical research. Explanation of the role and responsibilities of a GCP auditor. Setting clear expectations for the learning outcomes of the course.
2. Laying the Foundations: Today’s Regulatory Framework
- Introduction to the clinical development process, including the phases of clinical trials.
- Explanation of quality assurance (QA) and quality control (QC) in clinical research.
- Overview of international regulations and guidelines that define Good Clinical Practice (e.g., ICH GCP, FDA, EMA guidelines).
- Understanding the importance of compliance with these regulations for ensuring data integrity and patient safety.
3. Patient Protection in Clinical Research
- Detailed examination of the ethical principles of patient protection in clinical trials.
- Informed consent requirements: how to ensure that participants are fully informed and voluntarily participate.
- Role and responsibilities of ethics committees in safeguarding participants’ rights and well-being.
- Access to source documentation and maintaining patient confidentiality.
4. Foundations of GCP Auditing
- Key principles of planning and conducting GCP audits.
- Types of audits in clinical research (e.g., investigator site audits, system audits, process audits).
- Developing audit plans and checklists to ensure thorough and consistent auditing practices.
- Importance of maintaining independence and objectivity during audits.
5. Investigator Site Audits
- Detailed procedures for selecting and setting up audits at investigator sites.
- Pre-audit preparations: site selection criteria, risk assessment, and notification.
- Conducting site audits: reviewing informed consent forms, source data verification, and protocol compliance.
- Post-audit activities: preparing audit reports and follow-up actions.
6. Source Data Verification and Audit
- Importance of source data verification in clinical trials.
- How to verify data accuracy and consistency with source documentation.
- Evaluating data integrity and identifying discrepancies or non-compliance issues.
7. Investigational Medicinal Product (IMP) Management
- Regulatory requirements for the management of IMPs.
- Tracking IMP distribution, accountability, and destruction.
- Auditing IMP storage conditions to ensure compliance with GCP and GMP guidelines.
8. Critical Document Audits
- Auditing essential documents including protocols, informed consent forms, clinical study reports (CSRs), investigator brochures (IBs), and monitoring reports.
- Importance of document control and traceability in clinical trials.
- Reviewing documentation for completeness, accuracy, and regulatory compliance.
9. Non-Compliance and Fraud Detection
- Identifying and categorizing non-compliance issues.
- Evaluating the impact of non-compliance on data integrity and participant safety.
- Techniques for detecting potential fraud and misconduct in clinical trials.
- Understanding the consequences of fraudulent practices and reporting obligations.
10. Auditing Third Parties and Service Providers
- Auditing contract research organizations (CROs) and other service providers.
- Evaluating third-party compliance with GCP and contractual obligations.
- Managing risks associated with outsourcing and ensuring accountability.
11. System Audits
- Auditing processes across multiple clinical trials to assess systemic compliance.
- Process mapping techniques to identify gaps and areas for improvement.
- Ensuring consistency in processes to enhance overall quality assurance.
12. Audit Reports and CAPA Management
- Writing clear, concise, and objective audit reports.
- Structuring audit observations with evidence and regulatory references.
- Implementing Corrective and Preventive Actions (CAPA) to address audit findings.
- Monitoring CAPA effectiveness and ensuring continuous improvement.
13. Regulatory Inspection Readiness and Hosting
- Preparing for regulatory inspections (e.g., FDA, EMA, MHRA).
- Hosting inspections and ensuring smooth communication with inspectors.
- Role of the QA team in supporting inspection readiness and compliance.
- Post-inspection follow-up and addressing inspection findings.
Certification and Assessment
- Participants will receive GCP Auditor certification upon successful completion of the course and passing the final exam.
- The final exam is conducted online and can be taken at a time convenient for the participant.
- Most participants pass the exam on their first attempt.
