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Maintaining :: Modifications


A modification is any change made to your protocol after you receive approval/exemption from the IRB-SBS.  All changes must be reported to and reviewed by the IRB-SBS. While some modifications are simple changes, others can change the level of risk in a study; regardless of whether modifications change the level of risk, they need to be reported to, and in some cases, approved by the Board.  Like a normal protocol review, a modification’s level of risk will determine the review needed.

There are two procedures for modifying a protocol. If you are updating section B “Protocol Information”, please see the next section.  All other modifications must be submitted and reviewed via the Modification Form.

Section Topics

Updating Section B “Protocol Information”
Submitting a Modification Form
Modification Review Procedures

Next :: Updating section B