Changes to a Project

• Request for Amendment Form - PI Initiated Changes.
  (Version 05/22/08)
• Request for Amendment Form - Sponsor Initiated 
  (Version 05/22/08)
• Request for Amendment Form - VA VOTF 
  (Version 03/26/09)
  For study personnel changes. 

• Site Authorization Letter Template

Continuing Review

• Continuing Review Form
  (version 07/05/2007)

• Continuing Review Report 
  (Version 06/25/07)
  Not necessary for withdrawing a project
   
• Verification of Training (VOTF) 
  For reporting study personnel at Continuing Review. Changes to personnel should be submitted on a Request for Amendment Form.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

• Unanticipated Problems Report Form
  (Version 5/04/09) 
  
  Reportable events must meet all three of the following criteria:

1. Unanticipated or unexpected in nature, frequency or severity, AND
2. Related or possibly related to participation in the research (there is a reasonable possibility that it is related), AND
3. The event suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (not already referenced in existing study documents, such as the protocol, consent form or Investigator’s Brochure) 

• Deviation/Violation/
  Non-Compliance Report Form
  (Version 6/01/09)

1. Protocol Deviation: non-compliance with the protocol (typically does not significantly affect subject’s rights, 
   safety, welfare or integrity of data). 
2. Protocol Violation: accidental or unintentional changes to the IRB approved protocol procedures without prior sponsor AND IRB approval (generally affects subject’s rights, safety, welfare or integrity of data).  
3. Non-Compliance: failure to comply with Federal regulations, state or local laws, HSPP policy, determinations or requirements of the IRB, or requirements of VA guidance (if applicable).