Operational Approval Applications

Submit applications for Operational Approval (OA) using the Operational Approval to Conduct Research in the SHA Application Form. The Principal Investigator (PI) named on the OA application must be the same as on the Research Ethics Board-issued research ethics certificate. Include all relevant attachments with your application.

To complete the OA form online via a data collection tool created in REDCap™, researchers can:

• save and re-access partially completed forms;
• share the link to the form with other members of the research team to facilitate the completion of the form; and
• obtain the Principal Investigator’s signature electronically on the form (using a touch screen or mouse to provide the signature). 

Amendments

Once approved, the Principal Investigator (PI) must submit an Operational Approval (OA) amendment application for studies if any of the following applies:

• add or remove research personnel.
• add or remove departments or facilities.
• add, remove, or extend REDCap account access.
• add, remove, or extend any other electronic account access.
• revisions to SHA facilities being accessed/used.
• revisions to SHA services or resources provided.
• revision to the source of data collected from the Saskatchewan Health Authority (SHA) (e.g., hard-copy charts, Sunrise Clinical Manager, PACS).

The PI submits amendments on the amendment application form. The PI may also be required to request approval for the amendment from the Research Ethics Board (REB), depending on the nature of the amendment. 

Information to be provided to the OA team routinely, but does NOT need to be provided in a formal OA amendment application form, and can instead be forwarded via email referencing the OA file number:

• Renewal forms submitted to the REB for annual study renewal, and the corresponding REB Certificate of Approval (CoA).
• For studies that have a formal protocol: Amendments submitted to the REB, which include revisions to the protocol (but do not impact SHA services), and the corresponding REB CoA. 
• For studies without a formal protocol: Revisions to the data collection tool (where there are no changes to the source of the date being accessed from SHA), and the corresponding REB CoA. 

Additional questions can be addressed to SHA Research Approvals team:

• Regina/South: ResearchApprovalRegina@saskhealthauthority.ca
• Saskatoon/North: ResearchApproval.Saskatoon@saskhealthauthority.ca