ICH E6 (R3) GCP for Investigators & Clinical Site Staff – eLearning
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| Date | Product | Location | Price | |
|---|---|---|---|---|
| ICH E6 (R3) GCP for Investigators & Clinical Site Staff - eLearning | eLearning | USD 99 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
This engaging self-paced course is tailored specifically for clinical trial site staff, ensuring you understand your GCP responsibilities and can apply them confidently in your daily work. You will learn how to protect patient safety, ensure data integrity, and comply with regulatory requirements while making your role in the trial more efficient and effectiveWhat's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Course credit: 1 hour (3 month period to complete course)
- Complete the course at anytime, anywhere!
Course Description
Good Clinical Practice (GCP) is the internationally recognised standard that ensures clinical trials are conducted ethically, with the safety and well-being of participants as the top priority and with reliable, credible data. This self-paced online course is designed specifically for site staff, giving you a clear understanding of your role and responsibilities under the latest ICH E6(R3) guidelines.Through engaging content and real-world context, you will learn how GCP principles apply to day-to-day site operations, from informed consent to accurate data recording and reporting. The course also addresses the updates introduced in the R3 revision, helping you stay aligned with current regulatory expectations and industry best practices.Whether you are new to clinical research or have years of experience, this course will equip you with the essential knowledge to work confidently, maintain compliance, and contribute to the success of your clinical trials.Programme highlight
- Covers the key principles of Good Clinical Practice under the updated ICH E6(R3) guidelines
- Focuses on the specific responsibilities of clinical trial site staff
- Self-paced online format allowing flexible learning
- Designed to support both new and experienced site team members
- Aligns with current regulatory expectations and industry standards
Learning objectives
By the end of this course, participants should be able to:
- Explain the purpose and scope of ICH GCP E6(R3)
- Describe the responsibilities of site staff in protecting participant rights, safety, and well-being
- Identify requirements for accurate and reliable data collection and documentation
- Recognise the regulatory requirements for informed consent and ongoing participant communication
- Understand how to maintain compliance throughout the lifecycle of a clinical trial at the site level
Who should attend
This course is ideal for all members of clinical trial site teams who are involved in the conduct of clinical research, including:
- Study coordinators
- Research nurses
- Clinical trial assistants
- Data managers at sites
- Other site-based staff supporting clinical trials
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (4)
- Clinical Studies Operations (GCPs or ISO 14155) (8)
- Study and Site Management (2)
- Data Management and Informatics (4)
- Leadership and Professionalism (2)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
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