GCP Training: ICH E6(R2)
GCP Training: ICH E6(R2)
To purchase access for your team, or if you have any questions, email us at info@clinicalpathwaysresearch.com.
Course outline HERE
INTERACTIVE DEMO AVAILABLE BELOW
This GCP Training: ICH E6(R2) course overviews key components of the requirements of GCP for clinical trials found in ICH E6(R2) related to the role and responsibilities of the investigator, sponsor, and other stakeholders. It covers what is GCP, then moves on to review major regulatory agencies in the United States, the European Union, and Japan, then reviews essential documentation, and finally covers good documentation practices including ALCOA-C.
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.
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
Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6(R2).
Discover how the ICH global guideline affects your role.
Reflect on challenges and opportunities in implementing the GCP Guideline.
Identify practical applications of the guideline in your work processes including identifying methods to assess quality systems, and documentation.
Audience
All clinical research personnel
INTERACTIVE DEMO:
ONBOARDING OR ANNUAL REVIEW CURRICULUM
This course can be used alone or as part of the full curriculum, including:
GCP Training: ICH E6(R2) - Available HERE
Good Documentation Practices and ALCOA-C - Available HERE
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A) - Available HERE
Structure and Content of Clinical Study Reports (ICH E3) - Available HERE
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
Overview of 21 CFR Part 50 Human Subject Protection and 21 CFR Part 56 IRB/IEC - Available HERE
Overview of 21 CFR Part 11 Electronic Data / Signatures & 21 CFR Part 54 Financial Disclosure - HERE