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eRAP – Electronic Research Administration Portal

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Submission Requirements

Scientific Peer Review

Studies that have not received a scientific/peer review either by a grantingÌýagency, a cooperative group or an independent peer-review committee must receive a scientific/peer review prior to submission to the Ã山ǿ¼é IRB. The completed Scientific/Peer Review Form must accompany the submission or, in the case of an agency-reviewed study, a copy of the agency’s scientific review or reviewer’s comments. Master and Doctoral students must submit the scientific review completed and approved by their Advisory Committee (See Section 8 of the Scientific/Peer Review Form).

Mandatory Human Research Ethics Training

All Ã山ǿ¼é faculty, students, postdocs, residents and staff who will engage in research that involves human subjects must complete research ethics training prior to submitting an application for ethics review. This requirement can be fulfilled by completing the Tri-Council Policy Statement 2 (TCPS2) Course on Research Ethics (CORE). If you have completed the MSSS or NIH tutorial, or other recognized research ethics training program, please include a copy of the certificate with the submission package.

The CORE tutorial is available in English and French on the TCPS2 website: . Create an account and select Ã山ǿ¼é as your institution and use your Ã山ǿ¼é email address. If you have already completed the CORE tutorial with another institution, you can change your profile information to Ã山ǿ¼é by logging onto the tutorial and modifying your Account Details to revise your institutional affiliation and email address. The Ã山ǿ¼é IRB will verify completion of your training through the CORE program, or you can include a copy of your certificate with the submission package.

New Study SubmissionÌý

Please ensure that the following documents are ready before logging onto eRAP:Ìý

1. Protocol (Please see Protocol Requirements);
2. Study instruments, questionnaires, recruitment ads, etc.;
3. Consent Form(s)Ìý(Please consult Guidelines on Consent Forms andÌý Genetic Research and DNA Banking Consent Forms);
4. Scientific Review Form,Ìýsee above;
5. Cover letter containing a lay summary of the protocol;
6. Department Head Signature;
7. Summary of the budget, if applicable;
8. Approval letters from the appropriate departments if Ã山ǿ¼é-affiliated hospital facilities are to be used;
9. Studies that involve the use of investigational drugs or medical devices must include:

a) Investigator's Brochure or Product Monograph;

b)ÌýHealth Canada NOL - No Objection Letter;

c) Sponsor contact information for invoicing purposes.

NOTE:Ìý

• Consent forms are required in text format.Ìý All other documents shouldÌýbe uploaded as one (1) PDF document.ÌýÌý
• All forms must be signed off by the Ã山ǿ¼é Principal Investigator either signing off directly in eRAP, or by attaching the completedÌýPI Assurance Statement
• Only Ã山ǿ¼é email addresses will be accepted.Ìý The Office of the IRB will not send attachments to gmail, yahoo, hotmail accounts due to the confidential nature of the studies.
• Before submitting on eRAP, remember to SAVE and LOCK the form.

Ongoing Submissions

Protocol Amendments, document or consent form modifications:

On eRAP, click on Create NewÌýAmendment or Amendment Legacy; complete the form andÌýattach any revised documents.

Annual Study Renewal:

On eRAP, click on Create New Continuing ReviewÌý and complete the form well in advance of the study’s ethics oversight expiry date.

Study Termination:

On eRAP, click on Create NewÌýTermination and completeÌýthe form and attach copies of the study abstract if the results were published or presented at a meeting.

Study Adverse or Unanticipated Events (SAUE) reporting, protocol deviations:

On eRAP, click on Create New Reportable New Information and complete the Protocol Deviation or Unanticipated Issue Form.

Expedited / Delegated Review

Studies that involve minimal risk to participants or that involve the secondary use of data or biospecimens may be eligible for an expedited/delegated review. The Office of the IRB will determine if the study qualifies for an expedited/delegated review. There are no formal deadlines to submit an application for an expedited/delegated review. If you are uncertain whether the study qualifies for an expedited/delegated review, please contact the Office of the IRB submit2irb.med [at] mcgill.ca .

Submission Deadlines

Consult submission deadlines for Full Board meeting dates and their corresponding submission deadlines. Please adhere to the submission deadline to ensure a place on the corresponding meeting agenda. Full Board review of applications received after a specific deadline date may be postponed to a subsequent meeting date.

The deadline for all study amendments, modifications, consent form revisions is one (1) week before a scheduled meeting.