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Providence VA Medical Center, Rhode Island

 

Forms for each type of Protocol Submission - Continuing Reviews

Described below are the documents required for SRS/R&D protocol submissions.  All forms are located on the PVAMC Research SharePoint that limits access to only employees with a VA e-mail account.  Click here to access the SharePoint.

Required Forms for Continuing Reviews (conducted annually)

  • PVAMC Research Safety Continuing Review/Study Closure Form (please ensure any modifications between old and new BioSafety Forms are checked off and explained under the "Amendment" blocks on page 2 of the form)
  • Abstract (in lay persons terms)
  • Narrative of events from the past year
  • Updated training documentation.  Training must have been completed within the past year and must include general lab training (chemical hygiene/lab safetyhazardous waste, and bloodborn pathogen training) as well as any other required annual training (i.e. carcinogenformaldehydehazardous drug [if using a controlled substance]) is also required annually if used in the study.  Training slides are located on the Research SharePoint site (requires VA account), or if a unique chemical (i.e. ethidium bromide) you must document that you've reviewed that specific MSDS.
  • A dated copy of the laboratory Chemical Inventory.  Please highlight/identify all chemicals used in the study.
  • Specific laboratory SOPs
  • Copy of original BioSafety form
  • If laboratory is off station, the SRS or equivalent committee approval or exemption letter.
  • Annual Scope of Work for PI and all staff (only one required annually regardless of number of safety/animal studies).
  • Radioisotope Training (just radioisotope user).
  • If applicable, other Institutional Safety Committee approval letters.
  • Any other relevant documents provided by the investigator.

Lapsed Protocol Reinstatement Request

  • If your protocol expires past the SRS approval period, the protocol is considered lapsed and automatically falls into a suspended category.  No activity can occur with the study in this category.

Amendment

  • Cover memo detailing amendment (specific item [i.e., protocol]).
  • Modified materials (e.g., pertinent training documentation, protocol, BioSafety survey, etc.).

Responses to Conditionally Approved Items

  • Cover memo from PI detailing responses to conditions.
  • Copy of memo issued from the Chairperson (either committee).
  • Modified materials (e.g., pertinent training documentation, protocol, BioSafety survey, etc.).

Responses to Tables/Disapproved Items

  • Cover memo form PI detailing responses to the requests/conditions.
  • Copy of memo issued from the Chairperson (either committee).
  • Modified materials (e.g., pertinent training documentation, protocol, BioSafety survey, etc.).

Study Closure

  • Memo to the SRS, signed by the PI

 

_________________________________________      ______________________________
PI Signature (only)                                                           Date

 

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