Please use these forms to help us route your response to the appropriate reviewer. Do NOT use a revision memo.

• Explicit Change
  Insures your response is routed to a staff member for faster review.
  
  
• Tabled Response
  Insures your response is routed the next available full Board meeting.
  
  
• Full Board Correction
  Typically used when the Board has informally requested changes via an e-mail or discussion that occurred prior to the meeting. This helps us identify that your submission is already scheduled for a meeting and that this response needs to be forwarded to the reviewers.
  
  
• Other: use a coverletter, indicate what you are responding to.
  
  

• Revision memo
  • revise all paperwork affected by the revision.
  • include all paperwork referred to in your memo (protocol, advertisements, informed consent, etc).
  • follow the instructions on the Revision memo closely.
    
    

Continuing Review

Full Board & Expedited studies

• Continuing Review/Study Closure form
• Cumulative Adverse Event Table (EXCEL version)
• Minor Deviation Table for Continuing Review
• New copies of your Informed Consent Forms in our current format if enrollment continues.
  NOTE: if your project is covered by HIPAA and you wish to continue enrolling subjects, you must update all Informed Consent forms into the combined format with HIPAA language at Continuing Review - even if you previously received approval for the separate HIPAA authorization.
  
  

Continuing Review - HDE

• HDE - Continuing Review/Closure
  
  

• Adverse Event Reporting Form
  (instructions , definitions)
  
  
• Adverse Event - Non-reportable events
  Used to report events that occur at different sites on a different study (e.g. IND safety reports for same drug but different study, etc).
  (instructions, definitions)
  
  

• Deviation/Non-Compliance Reporting Form
  (Reporting Guide & Definitions, Minor Deviation Table for Continuing Review )
  
  

• Unanticipated Problem Reporting Form
  (reporting guide, definitions)