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Human Studies

Policies, Procedures, and Guidance Documents to Guide Research Teams on the Conduct of Research Projects

Clinical Studies Center

Study Visit Checklist Template (DOCX)
Human Research Studies: Essential Tasks to Do Before, During, & After (PDF)
Research Staff/Coordinator Responsibilities (PDF)
21 CFR 11 Compliance Letter (PDF)
Research Agreements with Collaborators SOP (PDF)

Documentation

Research Documentation Requirements (PDF)
Data Management Procedures (PDF)
Research CPRS Flags Policy (PDF)
Procedure for Scanning Research Documents (PDF)
Research Documents Scanning Request Form (DOCX)
Entering Notes in CPRS (DOC)
Removing Notes in CPRS (DOCX)
Research Note Titles and Templates (DOCX)
Research Consent Note Template for Paper Charts (DOCX)
Research Progress Note Template for Paper Charts (DOCX)
Source Documents Guidance (PDF)
Procedures to Post, Remove, & Edit Research Flags in CPRS (PDF)

Institutional Review Boards (IRBs)

Advarra Supplemental SOP (DOCX)
WIRB Supplemental SOP (DOCX)
VA Facility Endorsement Letter Template for Commercial IRBs (PDF)
ORD Requirements for Commercial IRB Consent Documents (PDF)
IRB Staff Assignment Matrix for Collaborative Studies (PDF)

Investigational Drug and Device Studies

Procedure for Management of Investigational Drugs (PDF)
Investigational Drug Studies - Pharmacy Fax Template (PDF)
10-9012 Scanning Procedures (PDF)
Management of Investigational Devices Procedure (PDF)
Management of Investigational Human Tissue Products (PDF)
Investigational Device Accountability Log (DOC)
Placing Orders in CPRS - Clinicians (PDF)
Placing Orders in CPRS - Coordinators (PDF)
Informed Consent Process (PDF)
AVAHCS Emory Combined ICF and HIPAA Template (DOCX)
AVAHCS Emory ICF Template (DOCX)
VA HIPAA Authorization Form 10-0493 (DOCX)
Notice of Privacy Practice SOP (PDF)
Medical Center Waiver Checklist for Pregnant Women (DOC)

Laboratory

VA Lab CLIA Certification (PDF)
Hematology Reference Ranges (PDF)
Blood Gas Reference Ranges (PDF)
Chemistry Reference Ranges (PDF)
Specimen Log for Research Freezers (DOCX)

Monitoring and Compliance

External Monitoring SOP (PDF)
Monitor Entrance Form (PDF)
Monitoring Exit Form (PDF)
ORD Guidance for Remote Monitoring (PDF)

Recruitment

Research Recruitment Policy (DOCX)
Recruitment Flyers SOP (DOCX)
Recruitment Letter Instructions (PDF)
Example Recruitment Letter (DOCX)
Example Recruitment Flyer (DOCX)
Opt-In Opt-Out Form (DOCX)
Request to Post Non-VA Research (PDF)
Referring to Non-VA Studies Policy (PDF)

Regulatory Practices

Regulatory Documents Policy and Binder Logs (PDF)
Accounting of Disclosures Form for Research (XLSX)
Procedure for Accounting of Disclosures Form (PDF)

Reportable Events

AVAHCS Reportable Event Policy (PDF)
Protocol Deviation Policy (DOCX)
VA Reportable Event Flowchart (PDF)
VA Reportable Event Assessment Form (DOCX)
Reporting Research Information Security Incidents (PDF)
ORO Guidance on Non-Compliance (PDF)
Issue Brief Template (DOC)

Study Closeout and Records Storage

Long Term Storage of Research Records SOP and Form (PDF)
Short Term Storage of Research Records SOP and Form (PDF)
Closing Human Research Studies SOP (PDF)
Close Out Summary for Human Studies Research (eIRB) (PDF)

Subject Reimbursement

Research Participants Reimbursement Procedure (PDF)
DIRECT EXPRESS Participants with Comerica card (XLSX)
DIRECT EXPRESS Participants without Comerica card (XLSX)
Cash Reimbursement Form (PDF)
Check/Direct Deposit Reimbursement Form (PDF)
FMS Vendor File Request Form (PDF)
Cash Reimbursement Form (PDF)

Tissue Banking and Data Repositories

Atlanta Data Repository Policy (PDF)
Research Data Repository SOP Template (DOCX)
Onsite Tissue Banking Form (DOCX)
Data Release Record Log (DOCX)
Data Repository Continuing Review Form (DOCX)
Biorepository Registration (PDF)
Registration with the Global Registry of Scientific Collections (PDF)

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