Bruyère Research Institute

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

Ame.ndment & Adde.ndum Form

Protocol Deviations and Violations

Incidental Findings & New Information

Incidental Findings Form

Serious Adverse Events

Serious Adverse Event Safety Reporting Form (SUSARs)

Serious Adverse Events Guidelines

Serious Adverse Events Reporting Form

The SUSARs form is for external/internal Clinical Trials Research Unit periodical reporting.