Research study checklist

This checklist is intended to help researchers ensure all requirements are completed before recruiting their first participant.

Per the Covenant Health research policy, the recruitment and screening of patients are research activities and require review, even if the research does not take place at a Covenant facility. All research activities that involve Covenant facilities, services, resources, patients, staff, physicians, volunteers and health records or data require operational/administrative review prior to any research activity taking place.

Questions? Contact research@covenanthealth.ca.

1. Review and approvals

Initiate the research ethics review and approval process with either the:

• Health Research Ethics Board (HREB) — University of Alberta
• Conjoint Health Research Ethics Board (CHREB) — University of Calgary
• Health Research Ethics Board of Alberta (HREBA) — Alberta Innovates
• Research Ethics Board Exchange (REBX) if multisite based on your study focus and university or organization affiliation

Trigger operational notice of study by ensuring Covenant Health is listed as a location on your ethics application:

• ARISE (HREB) 1.5, 2.0 Research Locations and Other Approval (include Alberta Health Services as a location if proposing Connect Care access).
• IRISS (CHREB & HREBA) 2.0, Impact and Operational Approvals

Not sure if your project requires an ethics review? If an ethics review is not required, please submit the determination letter from the REB to research@covenanthealth.ca.

2. Submit a digital intake form with appropriate documentation

Complete and submit the following:

• a CHRC digital research application intake form
• a Covenant HIA agreement completed and signed by the PI
• any sponsor or granting agency agreements for Legal/Risk Management Review
• any relevant protocols and quotation requests to Lab, Pharmacy or Diagnostic Imaging services as appropriate

3. Study start-up

If your study is sponsored or grant funded and requires a trust account for research, complete, sign and submit a Terms of Reference (trust accounts are managed by Covenant Finance). Email research@covenanthealth.ca if this is required.

4. Active study

Complete the following:

• Ensure that REB approval is renewed every year prior to the expiry date throughout the duration of the study, and submit any Serious Adverse Events (SAE) Reports to the REB.
• Submit any amendments or modifications to study protocols, agreements, etc. to both the REB.

5. Study closure

When the study is formally closed:

• Notify the REB by following the appropriate REB process as set by ARISE or IRISS.
• Notify the CHRC by submitting a final report.
• Contact researchprojects@covenanthealth.ca for knowledge exchange and dissemination opportunities for your study.