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):

• Foundations in Research Compliance
• Source Documentation in Research
• Introduction to ClinicalTrials.gov
• Expectations for Compliance in Human Subject Research 

ELECTIVE CLASSES (SELECT 3 + 1 BPN):

• Advanced Consideration of Reportable Events in Human Subject Research
• Research Data Management and Sharing
• Rigor, Transparency and Reproducibility in Research
• Research Participant Advocacy and Informed Consent
• Informed Consent: Models and Requirements
• Preparing for an FDA Inspection: Lessons from the Field
• Project Management: Implementing the Award Process
• Governing Regulations for Grants and Contracts
• Best Practice Network (BPN)