Investigator Resources and External Monitoring Visits

Investigator Resources:

• Investigator Handbook

• Research Study Team Members Training Sessions

  1. Documentation of Human Subjects Research in thePatient’s Health Record
  2. The Basics of Data Security
  3. Unanticipated Problems Involving Risk to Subjects or Others (UPIRSO)
  4. New Research Standard Operating Procedures (External Study Monitor Visits, Subject Recruitment and Advertising, Clinical Impact Statements)
  5. R&D Protocol Submission and Continuing Review Process
  6. Association for the Accreditation of Human Research Protection Program (AAHRPP) Overview
  7. STVHCS Human Research Protection Program
  8. STVHCS R&D Overview
  9. Preparing for a VA Compliance Audit
  10. The Bartter Research Unit (BRU) as a Vehicle to Support Research at the STVHCS
  11. Exempt Expedited Reviews What Needs IRB and R&D Approval
  12. VA Research IRB and R&D Approval Process
  13. The Informed Consent Process: From Rules and Regulations to the Protective Value of Ethics 
  14. FDA Guidance on Investigator and Study coordinator Responsibilities 

Quick References

External Monitoring Visits:

• External Monitor Agreement Form
• Report of Clinical Research Monitoring