Module 2: Best Practices in Clinical Research: Good Clinical Practice and Essential Documents
This self-guided course is designed to outline best practices for clinical research. You will gain a broad overview of human subjects research and learn best practices that can be adapted to any type of research. While these best practices are based in the principles of Good Clinical Practice (GCP) from the International Conference on Harmonization, this course does not fulfill requirements to complete GCP training and does not replace any other required training such as PEERRS.
No prior research experience is necessary and you can return to this module at any time for a refresher.
Audience
While the primary audience for this course is any member of a study team who is new to human subjects research, anyone with a U-M Level 1 account is more than welcome to take it.
This module will
Define Good Clinical Practice from the International Conference on Harmonization and explain its impact on the clinical research process.
Recognize how Good Clinical Practice is incorporated into best research practices.
Understand a broad overview of research and the best practices for high quality research.
How to Access This Course
This course is free and can be found here on the My LINC learning platform.
Related Learning
This course is part of the Research Basics series. Other courses in this series include:
Related Resources & Links
HRPP-GCP Training Requirements
International Council for Harmonization (ICH) Guidelines
Study Management Templates and Guidance (including Delegation of Authority Log and Documentation of the Informed Consent Process for Research Participation)
Standard Practice Guidelines (SPGs) (including Adverse Event Guidelines)
Conducting and Obtaining Valid Informed Consent (workshop)
Adverse Event Reporting Guidelines- IRBMED
ORIO Reporting Guidelines- IRBMED
FDA Guidelines for Drug or Device Studies
Medical School Office of Research
Ethical Abuses