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Forms Library

Study Start Up Forms
Ongoing Study Activities Forms
Translational Research Program Forms
Study Closure Forms
IRB Forms
Orientation and Education Forms
Non BRI/VMMC Staff Forms
General/Administrative Forms

START UP FORMS

  
FRM 0021.A CTMS Study Template
FRM 0022.B IDE Medicare Billing Preauthorization Checklist
FRM 0023.B Medicare IDE Part A Request
FRM 0024.B Medicare IDE Part B Request
FRM 0028.C Feasibility Checklist AKA Human Subjects Research Study Evaluation Checklist
FRM 0029.B Request for IRB & Funding Numbers
FRM 0030.A BRI/Investigator Compact
FRM 0033.A Scientific Merit Review Form
FRM 0039.A Study Start-Up Checklist
  Chart Review Protocol Template
  Non Interventional Protocol Template
  Protocol Template
  Clinical Trial Contract Review Request
  Device Impact Statement
  Pharmacy Impact Statement
  Nursing Impact Statement
  Radiology Impact Statement
  Laboratory/Pathology Impact Statement
  Clinical Research Center Impact Statement
  CRC Med Order Sample
  Request for Study-Related Research Funds
  BRI Feasibility Review Process for Clinical Research
  Online Study Summary Submission
  Consent Form Model Template
  Consent Form Instructions and Checklist
  Cooperative Review Application
  Emergency Use Drug or Device
  Exempt Status (Certificate of Exemption)
  Exempt Status Checklist
  Expedited Review Application
  Expedited Review Checklist
  Financial Disclosure Statements - more information
  IRB Full Review Application
  Model HIPPA Authorization Template
  Waiver of Authorization for Use and/or Disclosure
of Protected Health Information (“PHI”) for Research
  HIPAA - Auth. to Use & Disclose Protected Health Information (PHI) Form
  IRB Application Cover Sheet
  Patients’ Bill of Rights – VM Version
  Non-VM Investigator Patient Approach Procedures
  Translation Certificate
  Unaffiliated Investigator Agreement
  WIRB Checklist
  WIRB Patients Bill of Rights

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Ongoing Study Forms

  
FRM 0001.A Concomitant Medications
FRM 0002.A Note to File Template
FRM 0003.A Eligibility Checklist
FRM 0004.A Delegation of Authority Log
FRM 0005.A Adverse Event Flowsheet #1
FRM 0006.A PI & Study Coordinator Meeting Agenda
FRM 0007.A Mini-Coordinator & PI Study Update
FRM 0008.A Research Dictation
FRM 0009.A Prescription Completion Checklist
FRM 0010.A Ordering Form for Outside Services
FRM 0011.A Tissue or Specimen Transfer Instruction
FRM 0012.C Access for Outside Research Staff
FRM 0014.A Dispensing / Implant Accountability Log
FRM 0015.A Combination Factsheet/Checklist Template
FRM 0016.A Protocol Overview Template
FRM 0017.A Visitor Sign-in Sheet
FRM 0019.A Short Eligibility Checklist
FRM 0020.B Adverse Event Form (2nd version)
FRM 0025.A Medical History Template #1
FRM 0026.A Medical History Template #2
FRM 0027.A Physical Exam Template
FRM 0034.B Target & Non-Target Lesion Tracking Forms
FRM 0036.A SOP Comment Form
FRM 0037.A Protocol Violation & Exception Form(Single Event Form)
FRM 0038.A Unanticipated Problem Report Form
FRM 0041.A Protocol Deviation Form(Multiple Event Report)
FRM 0046.A Scheduling Form
FRM 0047.A Adverse Event - 2 Agents
  Consent Process Checklist
  SAE/UAE Reporting Flowchart
  Dictation Templates
  Online Study Modification
  Continuing Review Progress Report
  Financial Disclosure Statements - more information
  Serious and/or Unexpected Adverse Event Reporting Form
  Safety Report Form - Off Site
  Study Modification Form
  Accounting Travel Reimbursement Form
  BRI Invoice Template

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Translational Research Program

 
Policy for establishing a Registry and Repository  
Instructions to access samples from the IMD Registry  
Study Modification Form for Registry & Repository Project  
Gatekeeping Request Form  
BRI Material Transfer Agreement (MTA)  

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Study Closure Forms

  
FRM 0013.B Study Closeout or Termination Checklist
FRM 0018.A Study Closure Notification Checklist
FRM 0035.A Archival of Research Materials Checklist & Note to File
  Closure Report Form

IRB Forms

 
  Chart Review Application
  Consent Form Model Template
  Consent Form Instructions and Checklist
  Cooperative Review Application
  Cooperative Review Continuing Progress Report
  Emergency Use Drug or Device
  Exempt Status (Certificate of Exemption)

Exempt Status Checklist
  Expedited Review Application
  Expedited Review Checklist
  Financial Disclosure Statements - more information
  IRB Full Review Application
  Model HIPPA Authorization Template
  Waiver of Authorization for Use and/or Disclosure
of Protected Health Information (“PHI”) for Research
  HIPAA - Auth. to Use & Disclose Protected Health Information (PHI) Form
  IRB Application Cover Sheet
  Patients’ Bill of Rights – VM Version
  Non-VM Investigator Patient Approach Procedures
  Translation Certificate
  Unaffiliated Investigator Agreement
  WIRB Checklist
  WIRB Patients Bill of Rights
  Serious and/or Unexpected Adverse Event Reporting Form
  Safety Report Form - Off Site
  Study Modification Form
  Waiver for Recruitment of VM Patients for Research by Non-VM/BRI Staff Form
  UW Cooperative Agreement
  GHC Cooperative Agreement
  Swedish Cooperative Agreement
  FHCRC Cooperative Agreement

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Non BRI/VMMC Staff

 
FRM 0012.C Access for Outside Research Staff
FRM 0043.A Annual Renewal for Outside Research Staff Access

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Orientation and Education Forms

  
FRM 0042.B Employee Orientation Checklist
  Ethics Training
  GCP Training

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General/Administration Forms  
FRM 0045.A Clinical Research Purchase Requisition
  Draft Internal Budget
  ICF Checklist
  GRE Request Form

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