Source Documents – General

• Concomitant Medications
• Note to File Template
• Eligibility Checklist
• Short Eligibility Checklist
• Delegation of Authority Log
• Physical Exam Template
• Medical History Template #1
• Medical History Template #2
• Target & Non-Target Lesion Tracking Forms
• Dispensing / Implant Accountability Log
• PI & Study Coordinator Meeting Agenda
• Mini-Coordinator & PI Study Update
• Visitor Sign-in Sheet
• Scheduling Form
• Study Contact List

New Staff / Non-VMMC Staff

• Employee Orientation Checklist
• Access for Outside Research Staff
• Annual Renewal for Outside Research Staff Access
• Unaffiliated Investigator Agreement
• Non-VM Investigator Patient Approach Procedures

Other Forms / Guidelines / Checklists

• Combination Factsheet/Checklist Template

Safety Reporting

For studies reviewed by WIRB – visit http://www.wirb.com/ for submission forms and guidelines.

Source Documents

• Adverse Event Flowsheet #1
• Adverse Event Form
• Adverse Event - 2 Agents
• SAE/UAE Reporting Flowchart
• Unanticipated Problem Report Form

IRB Forms

• Serious and/or Unexpected Adverse Event Reporting Form
• Safety Report Form - Off Site
• Protocol Violations & Devations/WIRB
• Protocol Deviation Form
• Protocol Violation & Exception Form
• Emergency Use Drug or Device
• Translation Certificate

Continuing Review

• BRI IRB Continuing Review Progress Report
• CIRB Cooperative Review Continuing Review Progress Report
• WIRB Continuing Review Report Form

Changes to Research

• BRI IRB Study Modification Form - IRB notification for modifications in the protocol, consent form, personnel changes, etc.
• Online Study Modification - to update study activity status or modify an existing study listed on the website.

Recruitment

• Submission Guidelines
• Template Letters
• Centerpieces – VMMC’s Online Newspaper

Billing / Purchasing / Reimbursements

• Ordering Form for Outside Services
• Clinical Research Purchase Requisition
• Accounting Travel Reimbursement Form
• GRE and Restricted Fund Request
• BRI Check Request
• Most Frequently Used GL Expense Codes
• BRI Invoice Template