The Association of Clinical Research Professionals

Investigator Responsibilities

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This eLearning course will be accessible for up to one year from the date of purchase.


Course Description

This course will cover various responsibilities of clinical Investigators based on:

  • FDA Guidance for Industry: Investigator Responsibilities
  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 Guideline
  • Regulations set forth in 21 CFR Part 812, 21 CFR Part 312

This course focuses on the most current version of ICH E6(R2) guideline, which is in conjunction with other ICH guidelines relevant to the conduct of clinical trials (e.g., E2A (clinical safety data management), E3 (clinical study reporting), E7 (geriatric populations), E8 (general considerations for clinical trials), E9 (statistical principles), and E11 (pediatric populations)).

In addition to FDA Regulations and ICH Guidance Documents, the International Standard ISO 14155:2011E may apply to medical device studies and all other clinical investigations conducted Internationally.  Although this document is not referenced within this course, it is important to note its relevance when conducting research on an International level.

Learning Objectives

  • List the key regulations and guidance documents as they relate to the responsibilities of a Clinical Investigator
  • Identify key elements of Investigator responsibility
  • Describe the expectations for Investigator oversight of a clinical trial

Audience

New principal investigators, sub investigators, and all clinical research personnel.

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