VBRI

Veterans Biomedical Research Institute New Jersey

 

VBRI Home

NonProfit Authority FWA

Board Members

VBRI Forms Documents

Links

NAVREF

Board Meeting Minutes and Members Only

Employees Site

Research Forms

Required Training

AAHRPP

Research Procedures

Research Animals

Research Announcements

Reporting Misconduct

Research Home VANJHCS

General Information

 

For best performance, right click form/document link and save to your PC before using.

*No. of copies Needed 

*IRB Calendar 2009  IRB Calendar 2010

*IRB Statistics 2005     Last 12 months

*IRB Members Roster 2004  2005   2006 2006-late  2007 2009 2010

*How to write a proposal (1201.1 Handbook)

*ORD Mandate for FHPP Support Fee of $1200

* Check List for Human Studies

FORMS

INSTRUCTIONS

   

01   Cover Page,

 

 

 

02 Pages 1 and 2   , Page3  Funding source codes & Administrative Codes
03 Letter of Support Lab Service (if applicable)

Letter of Support Imaging (if applicable)

Letter of Pharmacy Support

 

Instructions for request to Pharmacy

 

05 Application for review of research 

or

Application for review animals or science only initial

or

R&D Application for Continuing Review

 

06 Human Research Determination form

Consent Form 10-1086 with Surrogate

Consent Form 10-1086  

Consent Log

Consent SOP

Consent Form Guidance  Readability Tips   DMC procedure for use

07 Scan Consent Request Form

 

08  HIPAA Waiver request

 PHI Disclosure Report 

Study Monitor Visit Report Form                         

HIPAA mandate  

PHI Disclosure Report Memo

Study Monitor Reporting Directive

09 Drug Information Form 10-9012

Investigation Device Supplemental Application

 
10  IT Security

The following Security Forms are for use as appropriate:

Application Take Data from VA form

Data transfer Agreement to another VA  

Data Transfer Agreement non-VA

Devices with PHI Inventory

 

ECAR (Electronic Computer Access Request): https://ecar.v03.med.va.gov/do/main/logon

 

SECURITY

 

 

 

ECAR is for requests for authorization to transport/utilize sensitive information outside VANJHCS protected environment and requests for IRM provided equipment 

11 Investigator's Responsibility Agreement  
12 Investigator's Personal Financial Disclosure  
13 Safety Form

14 Safety Committee Annual Review Form

15 Safety Training Form

MCMs Used on Safety Form

Research Safety Laboratory Training (large file 8 mb, right click and save to your PC before viewing for best performance)

   

Additional Initial Application Forms

Non-Vet 10-10EZ Form for Registration (2005)

 

Procedures for Non-Vets

Off Site Research Application Form

 

Instructions for Off Site Application

WOC Orientation Checklist   

WOC Certification  

VANJHCS Scope of Practice for Research Staff

 + CV + copy of licenses

 

Credentialed Employees are exempt from Scope of Practice

CRADA-CT Phase I and II

CRADA-CT Phase III,IV

CRADA-Material Transfer

CRADA-Investigator Initiated

CRADA-Science Only

CRADA-Devices

 

CRADA Guidelines

 

VANJ Health Care Animal Studies Forms

VA ACORP Forms (must use after Jan 1, 2005)

Required Training

VA Handbook Animal Use

DHHS forms  

Post Approval Activity Forms

Amendment Request

.

IRB Continuing Study or Closure Form

Safety Continuing Study Form

IRB Continuing Scope of Practice Form

.

Event/Problem Report Form

 

 

IRB and R&D Reviewer Tools

IRB Meeting Accession Regulatory Check List

IRB Emergency Use Reviewer Form

IRB Meeting Regulatory Check List

IRB Device Review Form

IRB Initial Review Form

IRB Finance Disclosure of PI Reviewers Form

IRB Continuing Review Form

IRB DMC Review Form

IRB Amendment Reviewer Form

IRB / R&D Members Conflict of Interest Form

IRB Review for Noncompliance Form

IRB Ad Hoc Reviewer Conflict of Interest Disclosure

Post Privacy Review form

IRB Reviewer's Reference Guide

VBRI

Visit http://www.vbri.org/forms.htm

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Send mail to robert.eng@post.harvard.edu with questions or comments about this web site.  Last updated Mar 12, 2010