Advanced Good Clinical Practice (GCP) Training: Incorporating Auditors' Expertise and Updated Guidelines (Revision 3)
Enhance your knowledge and understanding of Good Clinical Practice (GCP) principles and guidelines with our remote Advanced GCP Training program. This comprehensive training is designed to equip participants with valuable insights based on audit and inspection findings, ensuring that they are well-prepared to contribute actively to the quality and integrity of clinical trials.
Through interactive quizzes and engaging learning activities, participants will have the opportunity to reinforce their understanding and actively engage with the course material. Our training incorporates the updated guidelines
of Revision 3 of the ICH GCP, ensuring that participants are up-to-date with the latest industry standards.
The program also includes animated precourses that provide a solid foundation and assist in grasping the key concepts
necessary for successful completion of the training. Participants will have the opportunity to apply their newly acquired
knowledge to real-world scenarios, further enhancing their skills and understanding of GCP principles.
Upon successful completion of the training, participants will receive a 24-hours GCP Advanced Training Certificate registered
by TransCelerate, recognizing their commitment to professional development and adherence to high-quality standards
in clinical research.
Join us for this advanced training program and take your understanding of GCP to the next level. Become a confident and knowledgeable professional equipped to navigate the complexities of clinical trials and make a positive impact on patient safety and research outcomes. Should you have any further inquiries or require additional information, please do not hesitate to reach out. We look forward to welcoming you to our GCP training program!
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Knowledge and understandingEnhance your knowledge and understanding of GCP principles and guidelines -
Valuable insightsReceive valuable insights based on audit
and inspection findings -
Skills and knowledgeGain the skills and knowledge to actively contribute
to the quality and integrity of clinical trials -
Revision 3Learn about the revision 3 of ICH GCP guidelines -
Application of knowledgeApply your knowledge to real-world scenarios -
Animated precoursesWatch animated precourses to help you understand
the key concepts -
GCP advanced training Certificate24-hours GCP advanced training Certificate registered by TransCelerate -
GamificationInteractive quizzes are included to reinforce your understanding and ensure active engagement
- Clinical Research ProfessionalsThis training is valuable for professionals involved in clinical trials, such as clinical research associates (CRAs),
in-house clinical research associates (IHCRAs), clinical research coordinators, project managers, data managers,
study coordinators, and other individuals responsible for ensuring compliance with GCP standards. - Auditors and InspectorsAuditors and inspectors who conduct GCP audits and inspections will benefit from gaining insights based on audit
and inspection findings. This training will enhance their understanding of best practices and enable them to provide
more effective assessments. - Principal Investigators and Sub-InvestigatorsPrincipal investigators and sub-investigators involved in clinical trials will gain essential knowledge and skills to actively contribute to the quality and integrity of their studies. They will learn how to comply with GCP principles, effectively manage trial processes, and ensure patient safety.
- Ethics Committee MembersMembers of institutional review boards (IRBs) or independent ethics committees (IECs) responsible for reviewing and approving clinical trial protocols will benefit from this training. It will provide them with a deeper understanding
of GCP guidelines and help them make informed decisions regarding the ethical conduct of trials - Regulatory Affairs ProfessionalsProfessionals working in regulatory affairs, responsible for ensuring compliance with GCP regulations and guidelines, will find this training instrumental in staying updated with the latest industry standards, including the revisions of Revision 3 of the ICH GCP guidelines
09:00 - 09:15: Overview of the training objectives and agenda
09:15 - 10:45: Guideline Scope and Structure. Understanding the scope of ICH GCP
10:45 - 11:00: Break
11:00 - 12:00: Principles of ICH GCP (Principles 1 to 6)
12:00 - 13:15: Principles of ICH GCP (Principles 7 to 12)
13:15 - 14:00: Lunch
14:00 - 14:15: Quiz
14:15 - 15:45: Annex 1: Chapter 1: Institutional Review Board/Independent Ethics Committee (IRB/IEC) Responsibilities of IRB/IEC. Composition, functions, and operations. Procedures, records, and submission.
15:45 - 16:00: Break
16:00 - 16:30: Lessons learned based on audit and inspection finding.
16:30 - 16:45: Quiz
16:45 - 17:00: Practical workshop.
09:00 - 10:30: Investigator responsibilities. Chapter 2:
2.1 Qualifications and Training
2.2 Resources
2.3 Responsibilities
2.4 Communication with IRB / IEC
2.5 Compliance with Protocol
Lessons learned based on audits and inspections.
10:30 - 10:45: Quiz
10:45 - 11:00: Break
11:00 - 12:30: Investigator responsibilities. Chapter 2, Part 2.
2.6 Premature Termination or Suspension of a Trial
2.7 Participant Medical Care and Safety Reporting
2.8 Informed Consent of Trial Participants
2.9 End of Participation in a Clinical Trial
Lessons learned based on audits and inspections.
12:30 - 12:45: Quiz
12:45 - 13:30: Lunch
13:30 - 15:00: Investigator Responsibilities. Chapter 2, Part 3
2.10 Investigational Product Management
2.11 Randomisation Procedures and Unblinding
2.12 Records
2.13 Clinical Trial/Study Reports
Lessons learned based on audits and inspections.
15:00 - 15:15: Quiz
15:30 - 16:30: Practical workshop.
09:00 - 10:30: Sponsor. Part 1.
3.1 Trial design.
3.2 Resources,
3.3 Allocation of activities.
3.4 Qualification and training.
3.5 Financing.
3.6 Agreements.
Lessons learned based on audits and inspection finding.
10:30 - 10:45: Quiz
10:45 - 12:00: Sponsor. Part 2.
3.7 Investigator Selection.
3.8 Communication with IRB/IEC and Regulatory Authority(ies.
3.9 Sponsor Oversight
Lessons learned based on audits and inspection finding.
12:00 - 13:15: Sponsor. Part 3.
3.10 Quality Management.
3.11 Quality Assurance and Quality Control.
3.12 Noncompliance.
Lessons learned based on audits and inspection finding.
13:15 - 13:30: Quiz
13:30 - 14:15: Lunch
14:15 - 15:15: Sponsor. Part 4.
3.13 Safety Assessment and Reporting.
3.14 Insurance/Indemnification/Compensation to Participants and Investigators.
Lessons learned based on audits and inspection finding.
15:15 - 15:30: Break
15:30 - 16:00: Sponsor part 5.
3.15 Investigational Product(s).
Lessons learned based on audits and inspection finding.
16:00 - 16:15: Quiz
16:15 - 17:15: Practical workshop.
09:00 - 10:00: Sponsor part 5.
3.16 Data and Records.
3.17 Reports.
Lessons learned based on audits and inspection finding.
10:15 - 10:30: Quiz
10:30 - 10:45: Break
10:45 - 12:15: Data Governance, Investigator and Sponsor part 1.
4.1 Safeguard Blinding in Data Governance.
4.2 Data Life Cycle Elements.
12:15 - 13:45: Data Governance, Investigator and Sponsor part 2.
4.3 Computerised Systems
4.4 Security of Computerised Systems
4.5 Validation of Computerised Systems
4.6 System Failure
4.7 Technical Support
4.8 User Management
Lessons learned based on audits and inspection finding.
13:45 - 14:00: Quiz
14:00 - 14:45: Lunch
14:45 - 15:30: Appendix A: Investigators Brochure
15:30 - 16:30: Appendix B: Protocol and Amendments
16:30 - 17:15: Summary quiz
17:15 - 17:30: Closure of the training
Webinar speakers:
- Maxim BunimovichSpainMD, MRQA, SQA, CEO and GCP Auditor, The QARP
- Mark PoultonUKBSc (Hons), MRQA, Executive Director, Poulton Quality Solutions Ltd
- Suheila Abdul-KarrimSouth AfricaBSc (Hons) (WITS), CCRA, FACRP, CCRT, MICR CSci, RQAP-GCP, Clinical Research Consultant, Auditor & Trainer
100$