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IRB-HSR > Protocol Review Process > Number of Copies to Submit

 

 

 

 

 

 


Number of Copies to Submit to the IRB-HSR

Please use an IRB-HSR Routing Form as the cover sheet for ALL submissions.

New Protocol
Please see the instructions in  Protocol Builder to determine which documents are to be submitted.  In Protocol Builder, click on "Check Progress" and then click on "Create Forms."  Print out the sheet displaying the documents needed for submission.

Modifications
Expedited Approval:

If the modification is minor and/or does not increase risk to the subject:
The following documents will accompany the submission-

  1. One (1) original of the "Request for Modification Approval Form"
  2. If the study includes GCRC approval, one (1) original of the "Request for Modification Approval Form"-GCRC.
  3. One (1) copy of the protocol and/or the consent form with any changes tracked.  The tracked copy must contain the PI's signature, no additional signatures are necessary.  Please note:  a consent addendum must be created if the study is closed to enrollment.  As a general rule, the consent addendum should not be used if the study is open to enrollment.
  4. Two (2) additional copies of the consent form without the changes tracked.
  5. If applicable, the sponsor's summary of changes as well as their updated protocol and/or consent. 

Full Board Review:
If the modification is major and/or increases the risk to the subject or if full board review is required by sponsor include the following documents:

  1. One (1) original of the "Request for Modification Approval Form"
  2. If the study includes GCRC approval, one (1) original of the "Request for Modification Approval Form"-GCRC.
  3. One (1) copy of the protocol and/or the consent form with any changes tracked.  The tracked copy must contain the PI's signature, no additional signatures are necessary.  Please note:  a consent addendum must be created if the study is closed to enrollment .  As a general rule, the consent addendum should not be used if the study is open to enrollment.
  4. Two (2) additional copies of the consent form without the changes tracked.
  5. If applicable, the sponsor's summary of changes as well as their updated protocol and/or consent. 
The study team will be notified if a full board review is required and asked to submit electronic copies of all documentation to provide to the board members at the next scheduled meeting.

Status Report and Continuation Request Form
Original Status Form signed by principal investigator in hard copy to IRB-HSR office.  The current version of the protocol and each consent should be sent by email to irbhsrcontinuations@virginia.edu.

Revised 04-23-08