Full course description
The Compliance in Research Activities Certificate
The Compliance in Research Activities Certificate is most appropriate for research coordinators and study staff involved in federal-, state-, and University-level reviews and audits of research activities. Participants will learn practical and appropriate methods of developing and preparing regulatory forms and documentation to meet the expectations of compliance reviews and FDA audit processes.
FOUNDATION CLASSES (REQUIRED):
- RED 740 | Foundations in Research Compliance
- RED 741/742 | Source Documentation in Research
- RED 743 | Introduction to ClinicalTrials.gov
- RED 744 | Expectations for Compliance in Human Subject Research
ELECTIVE CLASSES (SELECT 3 + 1 BPN):
- RED 502 | Advanced Consideration of Reportable Events in Human Subject Research
- RED 304 | Introduction to Data Management
- RED 303/365 Rigor, Transparency and Reproducibility in Research
- RED 732 | Research Participant Advocacy and Informed Consent Process
- RED 503 | Informed Consent: Models and Requirements
- RED 404 | Preparing Your Study for Inspection
- Best Practice Network (BPN)