Good Clinical Practice (GCP) ICH E6(R3)

This is an online self-paced course with ten modules. Learners can choose to consume the content by reading, listening, or both. The estimated time to complete this course is three hours. You may save your progress and return to where you left off in the course.

1. Overview – 15 minutes
2. Introduction – 30 minutes
3. Institutional Review Boards and Independent Ethics Committees – 15 minutes
4. Investigator – 45 minutes
5. Sponsor – 20 minutes
6. Data Governance – 15 minutes
7. Investigator Brochure – 15 minutes
8. Clinical Trial Protocol and Protocol Amendment(s) – 15 minutes
9. Essential Records – 15 minutes
10. Course Conclusion – 5 minutes

This course maps to the following Joint Task Force (JTF) fundamental-level competencies:

• Domain 2: Ethical and Participant Safety Concerns
• Domain 3: Investigational Products Development and Regulation
• Domain 4: Clinical Study Operations (Good Clinical Practice)
• Domain 5: Study and Site Management (5.3, 5.5, 5.6)
• Domain 6: Data Management and Informatics
• Domain 8: Communications and Teamwork (8.2 and 8.3)

Learners can complete this course one time to receive ACRP Contact Hours and a certificate of completion. You will have continuous access to the course content and its associated resources, but you will not be able to receive additional ACRP Contact hours or a new certificate if you retake the course.

ACRP does not have a requirement on how often GCP training should be completed. We recommend that you check with your organization on how often they require training.

This course is recognized by TransCelerate BioPharma Inc. as evidence of Good Clinical Practice training.

This course is approved for 4.0 ACRP Contact Hours.

Contact Hour Requirements:

• Participants must complete and proceed through all modules and required materials.
• Participants must obtain 80% or higher on the final assessment to pass the course.
• After submitting feedback in the evaluation, participants will have access to their certificate of completion.

ACRP will incorporate the updated ICH Guideline for Good Clinical Practice E6(R3) into all ACRP Certification examinations within the next two years, based on its final adoption date of January 6, 2025. This ensures that candidates have sufficient time to accumulate the required 3,000 hours of professional experience under the revised guideline. Learn more >

Become an ACRP member! As an ACRP member, you’ll have access to free webinars and trainings (without contact hours) and will save between $30 and $200 on training programs (with contact hours). Join today >

Alternatively, if you would like to offer this training for a group of people from the same organization, we offer this opportunity through ACRP Employer Services. Contact us >