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Major and Minor Modifications

Major Modifications

Major modifications on protocols presenting greater than minimal risk to participants are reviewed and approved by the full Board (e.g., scientific and therapy changes, substantive changes to the informed consent document).
  • Documentation regarding major study modifications should be submitted to the Board using Romeo (log-in to Romeo using your username and password), using the same deadlines outlined for initial protocol review.
  • Major modifications to clinical drug trials that fall under Division 5 of the Food and Drugs Act require a Health Canada Non-Objection Letter for the amendment. The REB will only approve major modifications of this type after the NOL has been received. Under limited circumstances, the REB can waive the requirement for the Amendment Health Canada Non-Objection letter prior to activation of the protocol modification. The waiver is based on section C.050.008 of the Division 5 Food and Drugs Act, which allows safety-based protocol modifications to be activated immediately providing that the sponsor notifies Health Canada of such changes.
Major modifications to minimal risk protocols (those reviewed under the delegated stream) are reviewed by the Chair only. These are submitted using Romeo.
 

All modifications should be clearly identified in bold lettering or track changes in the protocol or in an accompanying letter. If changes to the informed consent document are required, these should also be clearly identified in bold lettering or by track changes. Clean copies with version dates, and version numbers on all documents will be required for final approval. 
 


Minor Modifications
  • Reviewed and approved by the Chair
  • Minor modifications do not involve significant changes to the design of the project. There are submitted using Romeo. The following are examples of minor modifications that fall under the delegated review process: minor Informed Consent Changes; minor scientific changes (e.g., changes in targeted sample size, accrual objectives, minor changes to inclusion/exclusion criteria). 
  • If a minor modification requires changes to the informed consent document, one bolded or tracked changes copy and one clean copy of the modified consent form must be submitted to the Board.
 
 
Additional Co-Investigators &/or Research Staff
The addition of a co-investigator and/or research staff that does not modify any study specific documents (i.e., consent forms contact section), does not require submission to the REB office.  Please send an email to the ROMEO lead that indicates the CHEO REB study number, the name of the individual, their role on the study and indicate that there are no changes to study documents.  Please ensure that the additional staff has the appropriate training certificates as well as a ROMEO account; if they do not, the staff will not be added to the study.
 
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