INTERACTIVE DEMO AVAILABLE BELOW

This Good Clinical Practice (GCP) Refresher course reviews the major requirements of GCP for clinical trials according to the global guideline ICH E6(R2) related to roles and responsibilities using industry case scenarios to support application and critical thinking. The course is presented with more activities and independent learning. It is recommended for clinical research professionals who have five or more years of experience. The full GCP Training course is recommended for those who have less experience or who have a gap in GCP knowledge.

This ICH E6 (R2) GCP Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. 

Course Length: 35 minutes

INCLUDES:

• Unlimited access to the content for 45 days from your initial day of purchase.

• Certificate of completion

• Case Studies

• Post-Assessment

• Knowledge Checks

LEARNING OBJECTIVES

1. Review major GCP requirements and Identify practical applications of the Guideline, including identifying methods to assess quality systems and documentation.

2. Relate GCP concepts during interactive activities to support application during a clinical trial.

3. Reflect on challenges and opportunities in the current state of the industry for implementing the GCP Guideline.

AUDIENCE

All experienced clinical research professionals who have previously trained on GCP and desire or require a refresher training. It is recommended to have a minimum of five years' experience with GCP at sponsor/CRO or site. Perfect for renewal.

INTERACTIVE DEMO:

ONBOARDING OR ANNUAL REVIEW CURRICULUM

This course can be used alone or as part of the full curriculum, including:

1. GCP Training: ICH E6(R2) - Available HERE

2. Good Documentation Practices and ALCOA-C - Available HERE

3. Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE

4. Structure and Content of Clinical Study Reports (ICH E3) - Available HERE

5. Overview of 21 CFR 312 Investigational New Drug Application (IND) and 21 CFR 314 Application for FDA Approval to Market a New Drug (NDA) - Available HERE

6. Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE

7. Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - HERE