United States Department of Veterans Affairs
Brooklyn Campus of the VA New York Harbor Healthcare System

Research and Development Program

GUIDE TO THE INVESTIGATOR: INITIAL STUDY PACKAGE
• PI IRB Initial Checklist
• Data Transfer Agreement
• Authorization to Transport and Utilize VA Sensitive Information Outside Protected Environments
• Tissue Banking Requirements
• Tissue Banking Form 10-0436
• Funding Source Codes
• Abstract Guidelines
• Guidance on Research Studies Using Investigational Drugs
• Investigational Drug Management Fees
• Codes & Instructions for Investigator Data Sheet
• Request to Review Research Proposal/Project
• Request to Review Research Proposal/Project Instructions
• Pharmacy Support Form
• Budget Form: Non-VA Research Funding
• Form 10-9012, Investigational Drug Information Record
• Application for Biospecimen Storage at a For-Profit Institution (VA Form 10-0474)

CREDENTIALING
• Education Verification Form
• pg 18 - Investigator Data
• Research Staff Credentialing Checklist
• Scope of Practice
• Research Financial Conflict of Interest Statement

HUMAN STUDIES FORMS
• Investigator's Manual: Human Subjects
• Informed Consent Instructions
• Informed Consent Template & Instructions (10/09)
• Sample Consent Form
• 10-1086 Informed Consent Form 10/1/09 (blank template)
• Human Studies Questionnaire (HSQ)
• Protocol Amendment IRB Submission Form
• Human Subject Enrollment Log
• Certification of Compliance with HIPAA Privacy Rule Requirements for Use of PHI Preparatory To Research
• IRB Report of Study Closure

ANIMAL STUDIES/IACUC FORMS
• Animal Component of Research Protocol (ACORP)
• ACORP Appendix 1 - NON-VA Animal Facility
• ACORP Appendix 2 - Antibody Production
• ACORP Appendix 3 - Test Substances
• ACORP Appendix 4 - Antemortem Specimen Collection
• ACORP Appendix 5 - Surgery
• ACORP Appendix 6 - Special Husbandry & Procedures
• ACORP Appendix 7 - Request to Use Pt Care Proc. Areas
• ACORP Appendix 8 - Request to Use Explosive Agents
• ACORP Appendix 9 - Additional Local Information
• IACUC Report of Study Closure

RESEARCH SAFETY SUBCOMMITTEE FORMS
• Research Protocol Safety Survey Form

ANNUAL REVIEW IRB FORMS: HUMAN STUDIES
• PI IRB Continuing Review Checklist
• Request for Continued Approval of Human Use Form

ADDITIONAL R&D FORMS
• Adverse Event Report
• Addition of Research Personnel
• Application for Case Report Review
• Certification of Exemption
• Consent Form Irregularities - Deficiencies
• LMS Employee Data Form
• Request for Expedited Review
• Request for Study Closure
• Report of Clinical Research Monitoring Visit

COMMITTEE FORMS
• RD Initial Review Checklist
• RD Continuing Review Checklist


Related Links

• R&D Home
• VA Research Programs
 
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