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 (ExternalStudy 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 

• Quick References 

        1. Determining Whether An Activity is Human Research 

External Monitoring Visits:

External Monitor Agreement Form

Report of Clinical Research Monitoring