Learning Outcomes

Principals to ICH

Principles and Practices of ICH GCP

Role and Responsibilities of IRBs in Clinical Trials

Lesson Summary

This module introduces you to the International Council for Harmonization and its Efficacy Guideline E6, which is dedicated to Good Clinical Practice (GCP) principles. You will learn about ICH's mission, working groups, and principles for GCP. The module also explains requirements concerning the role of IRBs and IECs in clinical trials.

Roles and Responsibilities of Trial Investigators

Quality Management of Clinical Trials

Trial Protocol Guidelines

Crucial Documents for a Clinical Trial

This module explains GCP requirements to conduct a clinical trial guaranteeing the safety of its human subjects. It teaches you about the roles of trial investigators and sponsors, taking consent from the trial's subjects, submitting safety reports, trial quality management and financing, ADR reporting, and Investigator's Brochure requirements.

Good Clinical Practice - ICH Guidelines E6 R2 - Course Assessment

Gain critical information about good clinical practice (GCP) in conducting safe clinical trials in this free course.

Good Clinical Practice - ICH Guidelines E6 R2

Clinical research involving human subjects is a very sensitive matter requiring careful decision-making by those involved. The ICH guidelines to good clinical practice allow researchers to conduct clinical trials with the correct methodologies. By completing this course, clinical research aspirants can gain detailed insight into conducting fruitful clinical research while ensuring the safety of all those involved.  ㅤㅤㅤㅤ

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