Revised October 2012
CTMB Audit Guidelines
Suggested Format for Reporting On-Site Auditing Activities
CTSU Auditing Procedures
Maintaining Audit Worksheets
Unified Site Coding Procedure
Title 45 CFR Part 46
Guidance on IRB Continuing Review
Guidance on Use of Expedited Review Procedures
Optional CTMB Audit Worksheet for IRB/ICC Component
Optional CTMB Audit Worksheet for Pharmacy Component
Optional CTMB Audit Worksheet for Patient Case Review Component
OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
PMB Section 15 from Investigator’s Handbook
Investigational Agent Accountability Record
Return Investigational Agent Form
Transfer Investigational Agent Form
Group Preliminary Report Template
Co-site Preliminary Report Template
Group Final Report Template
Co-site Final Report Template