The Women and Children’s Health Research Institute (“WCHRI”), on behalf of the University of Alberta (the “University”), offers research study database hosting and related services to University researchers and certain other collaborators, including as part of the RareKids-CAN: Pediatric Rare Disease Clinical Trials and Treatment Network collaboration (“RareKids-CAN”). By logging in to the REDCap system, you (the “REDCap User”, or “User”) acknowledge and agree that the following Terms and Conditions govern the provision of these services.

The University has the right to amend, modify or revise any term or terms of these Terms and Conditions at any time in its sole and absolute discretion. Amendments, modifications or revisions will be posted to the University’s REDCap support site at https://help.redcap.ualberta.ca.

You can download a copy of this document at the bottom of the page.

Services

The University maintains two licensed REDCap systems, one of which is validated to support Health Canada regulated clinical trials. Access to these systems is provided to researchers and research projects that fit the following criteria:

• The study database is the responsibility of a current faculty member at the University or is part of an agreed research collaboration;

• The study is consistent with the University of Alberta’s not-for-profit status. i.e. is not sponsored by an industry sponsor as defined by Health Canada; and

• The study has or will have ethics approval by the applicable research ethics board (“REB”). Other projects without REB approval, such as administrative support or quality improvement studies, may be allowable. Please consult the REDCap team at redcap@ualberta.ca. 

Support services include:

System Support

• Provision of a REDCap project for use in a single study as defined by the REDCap Project Request.

• Creation of end-user profiles for study team personnel, both local and at remote study sites.

• Basic helpdesk support from 9 am to 5 pm Mountain Time during regular University work days.

Project-level Support 

Project-level services such as construction of the study database, data management or analysis are available on a cost recovery basis. 

User Responsibilities

• Authorized project Users will ensure that any other research team end user’s REDCap project related privileges are revoked if they leave the research team or no longer require access to the project.

• User will use the REDCap system in a way that is compliant with applicable legislation, policy and procedure. This may include, but is not limited to:

  • The Food and Drugs Act of Canada.

  • ICH Guideline for Good Clinical Practice (“GCP”).

  • The Health Information Act of Alberta.

  • The Freedom of Information and Protection of Privacy Act of Alberta.

  • The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2.

  • The Copyright Act of Canada (unauthorized use of copyright material is forbidden).

  • Other applicable legislation in jurisdictions where participant data is collected. For example, investigators collecting data relating to subjects residing in Europe must comply with the General Data Protection Regulation (“GDPR”).

  • Applicable University of Alberta policies (“UAPPOL”). 

• Users are accountable for any actions performed in REDCap under their ID.

• Passwords and user accounts must be appropriately managed. 

  • Users should use institutional email addresses and should not use shared email addresses with their REDCap profile.

  • System accounts (login information) must not be shared between multiple users.

• Users’ computers must be protected against viruses and unauthorized use. (Login enforced and password protected screen savers enabled.)

• Users must immediately notify the University (redcap@ualberta.ca) in the event of a suspected privacy or data breach, in the event their access credentials are compromised or believed to have been compromised, or any other security incident relevant to use of the REDCap system.

In using this service, the User consents to receive all communications including notices, announcements, feedback, support or other information from the University’s REDCap support team. The REDCap support team may provide all such communications by email or by posting them as a notice on this website.

Additional information regarding "security and privacy best practices" can be found on this page.

University of Alberta Responsibilities

Software Licence

The University’s use of the REDCap system is governed by the REDCap Non-Profit End-User License Agreement which can be found at https://projectredcap.org.

System Administration

The University will:

• Host and maintain the REDCap systems in a University of Alberta data centre. This will include:

  • Appropriate hardware maintenance and upgrades as may be required from time to time.

  • Appropriate administration and maintenance of computer operating systems.

  • Maintenance and administration of the REDCap application, including system upgrades and patches.

  • Automated backup of the computer environment according to current University of Alberta policy.

• Run test scripts on the validated REDCap installation in order to satisfy the validation requirements of Health Canada and GCP, however the University offers no guarantees. Users and institutional sponsors should take steps to ensure that the available documentation meets their requirements.

• Initialize REDCap projects and end-user profiles on behalf of the Users. Study setup, creation and configuration of data collection forms is the responsibility of the Users or their designated data service provider(s), which may or may not include the WCHRI Data Coordinating Centre.

System Availability

• It is intended that both REDCap Platforms will be available twenty-four hours a day, seven days a week, except during scheduled maintenance periods. The University maintains a regular monthly service window during which time the system may be unavailable without prior notice (“Service Downtime”). The University shall endeavor to limit any such downtime to the Service Downtime window unless there is a critical security issue, or a defect that renders the REDCap system unavailable, in which case the University shall take steps to correct such deficiency immediately. 

• REDCap is implemented on VMWare virtual servers running in a sophisticated high availability environment. System snapshots are performed at intervals throughout the day and database backups are performed at intervals as defined by University policy. In the event that a system failure causes database corruption, the server and/or REDCap database will be restored to its last known good state. The University cannot guarantee there will be no loss of data, and shall not be responsible for any lost data that may result from such a system failure.

System Support

• Limited end user support (e.g. system access, resolution of login issues) is available by email from 9:00 am to 5:00 pm Monday to Friday, Mountain Standard Time (with the exception of statutory holidays). However, due to regular work commitments, an immediate response may not be available. The University will make reasonable efforts to provide a response to email contacts within 24 hours of receipt, Monday to Friday, during regular working hours.

• The University shall have the right, in its sole discretion, to access the data entered into the REDCap system from time to time, for the purposes of support, administration, and the performance of the University’s duties and for no other purposes.

• Certain local and/or regulatory policies require that study data be retained for a minimum period following the end of a study. This period differs with jurisdiction. As a result:

  • The University will maintain the study in an active state in REDCap until such time as all study activity is complete, as confirmed by the Users or their delegate. 

  • Following notification, the University will change the REDCap project status to ‘archived.’ This hides the study from the User’s list of projects and removes the ability to add or edit data. At any time during which the study is archived, an authorized project User may move the project back to ‘Production’.

  • At any time following study completion, the Users or their delegate can request that the project be deleted from REDCap. The University will then delete the project from the system in accordance with the University’s general retention policies. Deleted project data will remain in system backups for a complete backup cycle, after which time it will be permanently erased.

Data Ownership and Intellectual Property

Subject to applicable University policies and procedures which apply to University Users, the University has no rights of ownership over any study materials or study data that is contained in the University’s REDCap systems.

Warranties and Liability

THE UNIVERSITY DOES NOT MAKE ANY REPRESENTATIONS OR WARRANTIES REGARDING ANY MATTER SET OUT HEREIN, AND THE UNIVERSITY EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SERVICES, THE DELIVERABLES, OR ANY RELATED MATTER HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OR CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

THE UNIVERSITY SHALL NOT BE LIABLE FOR ANY LOSS OF PROFITS, DIRECT, INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES OF ANY KIND, AND EXPRESSLY INCLUDING LOSS OF DATA, PROFITS OR BUSINESS (EVEN IF THE UNIVERSITY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES), IN CONNECTION WITH THE SERVICES, THE DELIVERABLES, OR ANY RELATED MATTER.

THE EXCLUSIONS OF AND LIMITATIONS ON LIABILITY IN THIS SECTION SHALL BE APPLICABLE NOTWITHSTANDING THE NATURE OF THE CLAIM, WHETHER ARISING IN CONTRACT (INCLUDING FUNDAMENTAL BREACH), TORT (INCLUDING NEGLIGENCE) OR OTHER BASIS.

General

No part of these Terms and Conditions may be assigned, delegated, transferred or subcontracted to any third party without the prior written approval of the University.

These Terms and Conditions shall not be amended or supplemented except in writing by duly authorized representatives of the University.

Waiver of any term or condition of these Terms and Conditions shall not be binding on either party unless agreed to expressly in writing by both parties. Waiver of any provision of these Terms and Conditions shall not constitute a waiver of any other provision nor shall any waiver constitute a continuing waiver unless otherwise provided in writing.

These Terms and Conditions shall be interpreted and governed by the laws in force and in effect in the Province of Alberta, without regard to conflict of laws rules therein. The parties agree irrevocably to attorn to the exclusive jurisdiction of the courts of the Province of Alberta, the federal courts of Canada and all courts competent to hear appeals in connection with any dispute or controversy arising out of or in connection with the services.