Once all agreements and approvals are in place, the study may begin. MCHP will provide the researcher with start-up information on network/system access, space assignment (virtual and physical), system libraries and project access controls. To facilitate processing of the following submissions, always include in all correspondence unique project reference numbers assigned by organizations. Please forward copies of updated approvals for study amendments and annual Health Research Ethics Board (HREB) study renewal notifications to MCHP.
The following reporting requirements must be followed to ensure continued, uninterrupted, access to the data approved for your study.
1) Study Amendment Requirements
All changes to the original approved study protocol (e.g., data years, data sources, funding sources, investigators*) must be submitted and approved before proceeding with the changes.
- Health data provider
- Non-Health data provider - a letter signed by the original PI outlining the changes to be submitted for approval and referencing the original submission.
- University of Manitoba Health Research Ethics Board (HREB)
Please see the MCHP Research Amendment Completion Checklist form for assistance in completing a formal amendment. Note the checklist applies to both projects with and without data provider approvals.
* The Health Information Privacy Committee (HIPC) requires notification of any changes in the original submission with respect to investigators or anyone accessing line-level data. Notification is also required if someone other than one of the investigators becomes first author on a manuscript, regardless of whether the individual has access to line-level data.
2) Annual Report Requirements
The University of Manitoba Health Research Ethics Board requires an annual study status report.
- HREB reporting information
- Health data provider requirement - A copy of each study renewal notification received from HREB must also be sent to HIPC if Manitoba Health data are being used in the study.
Project Closure - a project is officially closed when the Researcher notifies the MCHP Repository Access Coordinator - for example, by sending a copy of the final HREB annual report. It may also be closed if the annual HREB reporting requirements have not been satisfied and/or such reports have not been sent to the Repository Access Coordinator. When a project is closed it is removed from the MCHP system and archived for seven years. MCHP requires renewed or updated approvals in order to restore data from the project.
Project Management / Analysis Resources
- Output review and vetting process (NOTE: This information is available from MCHP upon request)
- Meta Data (including Data Dictionaries)- [available internally only]
- Guidelines for Managing a Project - [see pdf document} - includes suggestions related to periodic review of project documentation, confidentiality and communication guidelines.
- Data validity checks at various stages of the research process [see pdf document]
Last updated February 28, 2018