Privacy Statement
The TRIAD Trial is sponsored by the Australian National University (ANU) and coordinated through The Australian Orthopaedic Association Clinical Trials and Analytics Unit. This Privacy Statement explains how personal information provided in connection with the TRIAD study is collected, used, stored and protected.
What information may be collected
If you take part in TRIAD, the study team may collect personal and health information needed to run the study and follow up your outcomes. This may include your name, date of birth, postcode, hospital, surgeon, the joint being replaced, the side of surgery, phone number, email address, questionnaire responses, and relevant information from your medical record.
In some circumstances, limited registration details may be entered before formal electronic consent for questionnaires and follow-up is completed, so that study information can be provided and consent can be sought through the RAPID platform.
How your information is used
Your information is collected so the TRIAD team can contact you, provide study information, obtain and record consent, link your questionnaire responses with your operation record, complete follow-up, and analyse the study’s primary and secondary outcomes.
Participants who consent through RAPID may also be able to view their own results, compare them with national averages in de-identified form, download their results, and choose whether their treating surgeon can see them.
How your information is stored and protected
TRIAD study data is stored within the secure RAPID platform and related study systems. The study documents state that security measures include established policies and software safeguards, an independent external security review of the system design, and penetration testing before data collection commenced.
Personal information is handled in accordance with applicable privacy and research governance requirements.
Who can access your information
Access to identifiable information is limited to authorised study personnel and contracted staff who require it for approved study purposes. Only you, and your treating surgeon if you choose to share your results, can access your individual patient-level results in the portal.
Data used in reports, presentations and publications will be de-identified. Individual participants and individual surgeons will not be identified in study outputs. Only non-identified data will be provided to the study sponsor.
How long information is kept
Study data collected through RAPID will be retained for a minimum of 15 years. Personal data will remain confidential unless disclosure is required by law.
Your choices
Participation in TRIAD is voluntary. Choosing not to participate, or withdrawing later, will not affect your treatment or care.
If you withdraw, no further follow-up data will be collected and no further contact will occur, although information already provided may continue to be used in analyses unless you specifically request its removal where that is possible under the approved study arrangements.
If a participant declines at the electronic consent stage, identifiable information entered during registration is removed, with only limited administrative details retained as required for study administration.
Future use of data
TRIAD data will be used for the analysis of the study’s approved outcomes. Any future use beyond the current study would require separate ethics approval.
Contact
If you have questions about privacy or about your participation in TRIAD, please contact the AOA Clinical Trials and Analytics Unit.
Kashi Ghadirinejad
08 8128 4528