Good Clinical Practice Micro-credential

The Good Clinical Practice Micro-credential is designed to develop an interprofessional, interdisciplinary, ethnically/racially/culturally diverse clinical and translational workforce with skills to meet the healthcare needs of the Buffalo community, Western New York region, and nation. It prepares learners to be ethical researchers throughout their careers. The digital badge allows learners to showcase their advanced knowledge and skills related to ethical research, which will make them more competitive applicants for future employment opportunities.

The micro-credential prepares participants to develop knowledge related to the protection of human subjects, main authoritative bodies, key codes, and scope of enforcement. In addition, it investigates how to prepare an application for IRB approval and how to describe the essential elements of voluntary informed consent. Learners will critique proposals for risks to human subjects and protections of vulnerable populations, and investigate the principles of research documentation, validation, and audit.

Curriculum — Videos:

Request and watch Good Clinical Practice videos from past Core Competency Workshop Series from the CTSI Education Workforce Specialist to build or hone key clinical practice skills.  Workshop videos are:

  • Surviving a Research Audit (presented by Richard J. Karalus, PhD)
  • What Makes a Clinical Trial GCP Compliant? (presented by Kimberly Brunton, RN, MSN)
  • ICH, GCP, CFR, ISO: Making Sense of This Soup of Acronyms (presented by Sanjay Sethi, MD)
  • When Is an Informed Consent Truly Informed? (presented by Christian Marks, PhD)

Curriculum — Assignments:

1) Research Audit 2) Case Study 1 3) Principles Analysis 4) Case Study 2

Research Audit Overview:

Write a short overview of how to prepare for an audit at a research project site.

For more information and to access videos, contact Education Workforce Specialist Catherine Sedota, MS, at cmp9@buffalo.edu.