Post-approval requirements
Post-approval requirements
Following protocol approval, researchers are required to report the following to the Research Review Office.
Some of these forms are PDF-fillable (
).
- Research subject logs
Upon protocol approval, investigators are required to keep research subject logs for all research study participants (unless they will remain anonymous), and are required to submit, to the Research Review Office, the subject log at the time of annual renewal, or on demand by the Research Ethics Committee. Subject logs must be recorded using the standard Research Subject Log Form (XLS).
- Consent form cover sheet
Some researchers may be required to submit copies of their research participant's consent forms to be filed in medical records. The consent form cover sheet (DOC) must be filed along with the consent form in medical records.
- Amendments made to protocol during approval period
Amendments to any of the approved research documents (e.g. protocol, consent form, advertisements, etc.) must be reported immediately using Form E - Immediate Reporting and Amendment ().
- Serious adverse events and new study information
Any unexpected/serious adverse event occurring during the course of the project that may affect the participation of research subjects, or any new information regarding treatment and intervention of patients, must be reported immediately using Form E - Immediate Reporting and Amendment
().
- Annual renewal of protocol
Investigators who wish to continue a protocol beyond the current approval period must inform the Research Review Office of this in writing at least one month before the approval period expires. When requesting an extension of the approval period, the investigator must submit a completed Form F- Interim Report ().
- Terminating a protocol
In order to terminate a research protocol, the investigator must submit a completed Form G - Termination Report ().
We are always trying to improve our forms. If you have any suggestions or comments, please contact the Research Administrative Secretary at rebecca.macdonald.chsm@ssss.gouv.qc.ca or by phone at (514) 345-3511 ext. 3698.
