Annexes
Annex A - Change of Investigator
Annex A is used to notify the REB of a change to the study team involving an Investigator, a Study Coordinator or another team member to whom the Principal Investigator allocates specific research authority. The corresponding change must be made to the “Study Delegation Log” in the research records.
Since changing the Principal Investigator is an amendment to the study, REB review and approval is required before making the change. Annex A is used to submit the information and must be accompanied by the sponsor's correspondence approving the change of Principal Investigator.
Annex B - Clinical Trial Review
Additional information is required when the study is a clinical trial subject to applicable federal regulations governing review and conduct of clinical trial. Annex B must accompany the application form submitted for the initial review of a clinical trial.
Annex C - Research Use of Radionuclides or Nuclear Substances
Radionuclides or nuclear substances administered to human subjects for research purposes fall under joint authority of the Radiation Safety Committee and the Research Ethics Board. Reviews are conducted according to guidelines of the Canadian Nuclear Safety Commission (CNSC) and MUHC policy and procedures. The CNSC document “Guidelines for Research on Human Subjects Using Radionuclides (GMA-5)” is followed for the reviews. Permission to use a nuclear substance for research purposes "may" involve an assessment by the Radiation Protection Service.
If unsure what reviews are required when a study includes medical radiation exposure, please contact the Research Ethics Office at reo [at] muhc [dot] mcgill [dot] ca before submitting for REB review.
It is necessary to know the answers to the following questions for the REO to offer appropriate guidance:
- is the radiation exposure in the study being done for diagnostic,
therapeutic or research purposes?
- who will do the dose calculation for each research subject exposed to the
radiation described in the research protocol?
- who is the designated supervising physician who will administer the radioisotopes according to the research protocol?
To discuss using a nuclear substance in a research context, you may contact Dr. Christian Janicki, Radiation Safety Officer at 514-934-1934, ext. 43866 or christian [dot] janicki [at] muhc [dot] mcgill [dot] ca
Annex D - Summary of Local Adverse Events
When submitting an SAE Report involving an MUHC study subject to the REB the Investigator must append Annex D that serves as the 'Local Summary' log of all reportable SAEs' arising from conduct of the study.
Note: Only a document in Word is suitable for this particular form.
Annex D [doc]
Annex E - Summary of Non-Local Adverse Events
When submitting an SAE Report not involving an MUHC study subject to the REB the Investigator must append Annex E that serves as the 'Non-Local Summary' log of all reportable SAEs' arising from conduct of the study.
Note: Only a document in Word is suitable for this particular form.
Annex E [doc]
Annex F - Summary of Protocol Exceptions
A Protocol Exception is a minor deviation from the approved research protocol or other study condition of a non-serious nature and therefore is non-reportable to the REB. Should the study sponsor suggest the Investigator report a Protocol Exception to the REB, all such events are listed on Annex F to the Protocol Exception Report.
Such reports are submitted for “information purposes”, to the REB only at the time of Continuing Review.
Note: Only a document in Word is suitable for this particular form.
Annex F [doc]
