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This ICH E6(R3) Good Clinical Practice (GCP) course presents key components of the requirements of GCP for clinical trials found in ICH E6(R3) related to the role and responsibilities of the investigator, sponsor, and other stakeholders. Content includes an overview of GCP; responsibilities for stakeholders to maintain GCP; essential records; informed consent and ethics commmittees, good documentation practices including ALCOA+.

This ICH E6 (R3) 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. 

This course can be used alone or as part of the full curriculum; for more information refer to the additional information below.

Course Length: 75 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. Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6(R3)

2. Discover how the changes in the guideline affect organizational processes and stakeholder roles and responsibilities

3. Identify practical applications of the guideline in your work processes

Audience

All clinical research personnel

ONBOARDING OR ANNUAL REVIEW CURRICULUM

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

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

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

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

4. 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

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

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