Additional Resources

HIPAA and Clinical Research

All non-UH personnel involved with Clinical Research at University Hospitals are required to complete a one-hour live training session on how HIPAA (the Health Insurance and Portability and Accountability Act) relates to clinical research at UH. View the HIPAA and Clinical Research flyer (PDF) with additional details. Training must be completed by April 30, 2011. View slides from the HIPAA and Clinical Research presentation (PDF).

Useful Links

• The Belmont Report
• ClinicalTrials.gov
• The Declaration of Helsinki
• University Hospitals Institutional Review Board Policies and Procedures
• FDA Regulations Relating to Good Clinical Practice and Clinical Trials
• FDA Information Sheets for IRBs and Investigators
• Office for Human Research Protections
• Office of Research Integrity
• Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
• Department of Health and Human Services—Regulations

Office of Research Compliance - Case Western Reserve University

For more information about:

• Core Certification
• CITI On-line Basic Training
• Continuing Education Credits (CRECs)
• Research Seminar Series

Other Educational Resources for Research Professionals

Association of Clinical Research Professionals (ACRP membership)

• Certification
• Continuing Education
• Workshops
• Conferences
• Research Conduct
• Clinical trials
• Grants and Contracts
• IRB

The Coordinators' Forum (articles)

• Scientific Misconduct entitled "Are research coordinators at risk" and follow-up document with feedback on scientific misconduct
• Recruitment
• Informed Consent

Society for Clinical Research Associates (SoCRA)

Society for Research Administrators (SRA)