Atlanta VA Health Care System

Conducting Human Research

Conducting Human Research at the Atlanta VA

Below are policies, procedures, and forms guiding the conduct of Human Research at the Atlanta VAMC.  Questions can be directed to the following:

Collaborative Research Worksheets, Data Inventory and eRRRP Submissions: 
David Knight, Science Information Officer: david.knight2@va.gov 
Derek Key, Assistant SIO: Derek.Key@va.gov 

For IRB Submissions and eIRB processes:  Daniel Roysden, Ph.D., VA/IRB Liaison: droysde@emory.edu
 
For preparing a project submission in both eRRRP:  Contact the SIO Office-
David Knight, Science Information Officer: david.knight2@va.gov 
Derek Key, Assistant SIO: Derek.Key@va.gov 
 
For Data Repositories, Quality Improvement/Engagement questions, Reportable Events, and Protocol Deviations: Jennifer Whelan, Human Research Protection Program Quality Manager: jennifer.Whelan@va.gov
 
For preparing a project submission in both eRRRP and IRB, the conduct of Research, CPRS and Reportable Events:  Jane Guidot, Clinical Studies Center Manager: jane.guidot@va.gov 

IF YOU CANNOT FIND WHAT YOU ARE LOOKING FOR CONTACT JENNIFER WHELAN AT EXT. 3452 

VA Clinical Studies - Human

• Research Participants Reimbursement Procedures
• Direct Express Forms
• With Comerica Card
• Without any existing Card
• Cash Reimbursement Form     
• Check/Direct Deposit Reimbursement Form 
• FMS Vendor File Request Form

IRB Staff Matrix Form 

Accounting of Disclosures

• Procedure for Completing the Accounting of Disclosure Form for Research
• Accounting of disclosures Spreadsheet for Research 

Clinical Studies Center

• Human Studies Orientation PowerPoint Presentation 
• Clinical Studies Center Operating Guidelines 
• Essential Things to do before, during, and after research studies 
• Research Agreements with Collaborators Procedure
• Research Staff Responsibilities 
• Scope of Practice
• Study Visit Checklist  
• 21CFR11 Compliance Letter

Close Out and Storage of Research Records

• Long Term Storage of Research Records Policy
• Long Term Storage of Research Records Form 
• Short Term Storage of Research Records Policy 
• Short Term Storage of Research Records Request Form
• Procedures for Closing Out Human Research Studies  
• Close out Form To be submitted to IRB 

CPRS and Documentation

• Research Documentation Requirements  Updated May 2018
• Data Management Guidance
• Entering Notes in CPRS
• Procedure for Scanning Research Documents   
• Procedure for Setting Up Research Clinics in CPRS  
• Research Documents Scanning Request Form Updated May 2018
• Research Notes Titles and Templates 
• Research Progress Note Template for Paper Charts  
• Research CONSENT Note Template for Paper Charts 
• Source Document Guidance 
• CPRS Flags
  •  Procedures to Post, Remove, & Edit Research Flags in CPRS  
  •  Category II (Medical Record) Flag and Waiver Policy  

HIPAA Authorization

• HIPAA Alteration (Waiver) Worksheet   (this will take you to the Emory IRB site) Updated January 2018
• VA HIPAA Authorization Template 
• VA HIPAA Revocation Form 
• 18 HIPAA Identifiers 

Informed Consent

• Informed Consent Process 
• Scanning the Informed Consent Form Optional
• Radiation Risks Suggested Language for ICFs 
• VA Form 10-3203 Consent for Use of Picture and/or Voice
• VA Form 10-5345 Authorization to Release Medical Information 
• VA Informed Consent Form Template Updated July 2018
• VA Informed Consent Form Template - with track changes   Updated July 2018
• Worksheet for Waiver of Documentation of Consent - Emory     (this will take you to the Emory IRB site) Updated January 2018
• Worksheet for Waiver of Consent or Elements of Consent - Emory  (this will take you to the Emory IRB site) Updated January 2018
• Medical Center - Waiver for Children Certification Form 
• Medical Center - Waiver for Pregnant Women/Partners Certification Form 

Investigational Devices and Investigational Tissue Products

• Investigational Device Accountability Log 
• Investigational Device Procedure 
• Investigational Tissue Products Procedures 

Investigational Drugs

• Assessment of Pharmacy Impact Form
• Fax Template for Investigational Drug Orders 
• Investigational Drug Information Record - VA Form 10-9012 
• Investigators Instructions for Placing Orders in CPRS for Investigational Drugs 
• Management of Investigational Drugs Procedure  Updated May 2018
• Procedure For Scanning the Investigational Drug Information Record - VA Form 1090-12   
• Research Coordinator's Instructions for Placing Orders in CPRS for Investigational Drugs

Laboratory

• CAP - VA lab
• CLIA Certification - VA Lab
• Laboratory Reference Ranges - VA Lab Updated May 2018
  • Blood Gas
  • Hematology
  • Chemistry
• Specimen Log for CSC Freezer 

Monitor Visits

• Monitoring Visit Report - Entrance Briefing 
• Monitoring Visit Report - Exit Briefing 
• Procedure for External Monitoring Visits Atlanta VAMC
• VHA Privacy Policy Instructions for Monitors  

Notice of Privacy Policy (NOPP)

• NOPP acknowledgement form - VA Form 10-0483
• Notice of Privacy Practices Procedure for Non-Veterans 
• VA Notice of Privacy Practices (NOPP) 

Protocol Deviations and Noncompliance

• Protocol Deviation Policy 
• ORO Guidance on Non-Compliance 
• Steps to Filling out an eIRB Protocol Deviation
• ORO Guidance Research Information Security
• Issue Brief Form
• Protocol Deviation-Noncompliance Log Sheet

Recruitment  

• Recruitment Policy
  • In Person Recruitment Policy
  • Recruitment Letter Policy
    • Sample Recruitment Letter 1 Updated July 2018
    • Sample Recruitment Letter 2 Updated July 2018
  • Opt-In Opt-Out Form
• Recruitment Flyer Policy
  • Sample Recruitment Flyer Updated July 2018
  • Logo - Local AVAMC (Download only and insert into document) 
  • Logo - National (Download only and insert into document) 
• Referring Veterans to Non-VA Studies 
• Request to post advertisement for Non-VA Research 

Regulatory Binder

• Regulatory Documents Policy 
• Study binder cover 
• Regulatory Binder Instructions 
• Protocol Tracking Log 
• Accounting of Disclosures Form 
• Modifications Log 
• Record of Approved Consents Form 
• Reportable Events Log Appendix C 
• Protocol Deviation/Violation Log 
• Safety Reports Log 
• Study Subject Log 
• Staff Signatures and Delegated Responsibilities Form 
• Research Staff Training Log

Reportable Events (This Section is completely revamped)

• Reportable Event Policy
• How to do a Reportable Event 
• Reportable Event Flowchart
• Steps for Filling out a Local Event
• Steps for Filling out an External Event
• Reportable Events Assessment Form  
• Reportable Events Assesment Summary

Research Compliance

• ICF audit tool 
• HRPP audit tool 

Research Data Repositories and Biorepositories

• Biorepository Registration 
• Registration with the Global Registry of Scientific Collections
• On-Site Tissue Banking Form 
• Data Repository Policy 
• Data Respository SOP Template   Sample Form 
• Data Release Record Log 
• Data Repository Continuing Review Form  

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