SIV Agenda

“STUDY TITLE”

PI

IRB # / IND-IDE#

DATE and TIME

1. Investigator Responsibilities (Investigators must be present)
   • General and Study-Specific Study Responsibilities
   • ClinicalTrials.gov review (ORRAClinicalTrials-govAdmin@uams.edu)
   • Medical Monitor Responsibilities
2. Regulatory Binder
   • Form FDA 1572 or Investigator Agreement
   • Sponsor-Site Agreement
   • IND / IDE Monitoring Plan
   • Financial Disclosure Forms for PI, Sub-Is
   • CVs for PI, Sub-Is, Medical Monitor
   • Medical Licenses for PI, Sub-Is, Medical Monitor
   • HSPT / GCP Training; Protocol-Specific Training
   • Laboratory certification and normal ranges
   • Investigational Product (IP) information; Label; Investigator Brochure; Package Insert; Manual
   • IRB-approved protocol
   • IRB-approved informed consent form
   • IRB-approval letters / submissions
   • FDA Approval; ClinicalTrials.Gov; Contract and Budget Approval
   • Sponsor Correspondence
   • Delegation of Responsibility Log
   • Case Report Forms (blank copies)
   • Other Essential Documents:
     • Screening-Enrollment Log
     • Adverse Event Log
     • Deviation Log
     • Monitor Sign-In Log
     • IP Accountability Log
3. Protocol Review (Investigators must be present)
4. Informed Consent Process and Procedures
5. Case Report Forms and Source Documentation
6. Adverse Event Reporting (Investigators must be present)
7. Protocol Deviations and Violations
8. Monitoring Procedures and Schedule
9. Investigational Product Dispensation and Accountability
10. Questions?