Reporting Forms
Amendments/Addendums
Please allow at least two weeks for the processing of all amendment/addendum requests.
For amendments and addendums, please submit the following form, along with all requested changes clearly outlined within the BREB, protocol, consent forms, advertising materials, etc.:
You must use either track-changes or highlighting, otherwise your amendment will not be reviewed.
For the addition of new staff, please submit the addendum form, a signed pledge of confidentiality, and the TCPS 2 certificate (issued within the last five years).
Amendments and Addendums Form |
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Protocol Deviations and Violations |
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Incidental Findings & New Information |
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The SUSARs form is for external/internal Clinical Trials Research Unit periodical reporting.