Ongoing Activity
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
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
- Update study on BRI website by submitting the Change Study Activity Status
- BRI IRB Study Modification Form - IRB notification for modifications in the protocol, consent form, personnel changes, etc
- Online Study Modification - to 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