Privacy Notice for Clinical Trials – Australia



Xenon Pharmaceuticals Inc., and its wholly owned subsidiaries (together referred to as “Xenon”) are committed to protecting the Personal Information we process for the purpose of conducting clinical trials. This Privacy Notice sets forth the privacy principles and procedures and the technical security measures we follow to keep Clinical Trial Data private and secure.

Xenon is subject to the Personal Information Protection and Electronic Documents Act (“PIPEDA”), Canada’s federal privacy legislation for private bodies, where personal information crosses provincial boundaries and international borders.  We are also subject to applicable legislation in Australia where some of our clinical trials are conducted, for example the federal Privacy Act (“the Act”), the Australian Privacy Principles (“APPs”), and state and territory legislation specific to privacy.

This privacy notice is for data subjects participating in trials in Australia , click here for privacy notices for other countries.

If you or your child are a Clinical Trial Participant and would like more information about your trial or to review your Informed Consent Form, please contact the physician or hospital that enrolled you in the trial.  For the purposes of this Privacy Notice, references to “you” or “your” means a Clinical Trial Participant (including where a caregiver may be accessing this Privacy Notice on behalf of a Clinical Trial Participant).  

Xenon and Clinical Trial Data

Xenon does not collect Clinical Trial Data directly from individuals during the course of our clinical trials. Instead, we receive Pseudonymized Data from the Contract Research Organizations (“CRO”) and service providers (“third parties”) that we engage to carry out the study. 

Investigators enrolling Clinical Trial Participants in the study will provide information about the trial, how Personal Information will be managed and protected, and a link to this Privacy Notice at the time of enrollment.

If you are participating in a clinical trial and would like more information about the specific trial in which you are enrolled, the Informed Consent Form that you completed for the trial or the Personal Information you have provided for the trial, please contact the physician or the hospital that enrolled you in the trial. Xenon will not be in a position to identify you personally from the trial data we hold, given we only collect Pseudonymized Data.

Privacy Officer Information

Xenon has designated a Privacy Officer responsible for overseeing our privacy management program and compliance with privacy legislation.

Gary Donaldson
200 – 3650 Gilmore Way
Burnaby, British Columbia
Canada V5G 4W8
T: (+1) 604-484-3337
E: privacy@xenon-pharma.com

Scope

This Privacy Notice applies to Personal Information that is received by Xenon in any format, including electronic and paper, for the purposes of conducting a clinical trial in Australia.  More information about the third party organizations we engage to conduct trials can be found below.

Definitions

“Clinical Trial Participant” means an individual participating in a clinical trial and providing Personal Information to third parties Xenon has contracted with to conduct the study.

“Personal Information” means information or an opinion about an identified individual, or an individual who is reasonably identifiable:

  1. whether the information or opinion is true or not; and
  2. whether the information or opinion is recorded in a material form or not.

Personal Information includes Personal Health Information.

“Personal Health Information” means any personal information about your health or disability. It includes information or opinion about your illness, injury or disability. Personal Health Information is a category of sensitive Personal Information.

“Pseudonymized Data” means Personal Information and Personal Health Information that has been de-identified. This means it can no longer be attributed to a specific individual without the use of additional information. Personal Information will be considered pseudonymized provided that such additional information is kept separately and is subject to technical and organizational measures to ensure that the Personal Information is not attributed to an individual. Xenon will protect Pseudonymized Data with the same care and high standards as Personal Information.  Note that date of birth is collected and processed for this trial.  Your child’s date of birth is considered personal identifying information and there is a risk that it could be used to identify your child.   Your child’s Personal Information (excluding date of birth) will be pseudonymized to protect your child’s privacy.

“Anonymous Data” is information which does not relate to an identified or identifiable natural person or Personal Information rendered anonymous in such a manner that the data subject is not or no longer identifiable. Privacy legislation does not concern the processing of Anonymous Data.

“Clinical Trial Data” is the data collected and processed by Xenon for clinical trial purposes. It includes Pseudonymized Data received from third parties as well as new data generated by Xenon and third parties based on data collected for the clinical trial. These new data may not relate to an identified or identifiable natural person.

“Processing” means any operations or set of operations performed on Personal Information. It includes the collection, use and disclosure of Personal Information as defined in Canada’s Personal Information Protection and Electronic Documents Act (“PIPEDA”).

Collection of Personal Information

When individuals become Clinical Trial Participants, Personal Information will be collected and processed for the purpose of scientific research into the effects of medical treatment.

Xenon processes Clinical Trial Data based on your consent.  The hospital or physician enrolling you in the trial will obtain your consent prior to the collection of your data using an Informed Consent Form.

Types of Information Processed

Xenon will pseudonymize the following Personal Information using a unique subject identification number:

  • Personal details – date of birth, sex
  • Health information
    • Physical details – height, weight
    • Physical health data
    • Psychological details – quality of life rating
    • Genetic data related to genetic research
  • Data revealing racial or ethnic origin

Use and Disclosure

Xenon will use Pseudonymized Data for the purposes of conducting a clinical trial. We contract with a Contract Research Organization (CRO) to run a trial based on the protocols, or “instructions”, we have developed. The CRO selects Investigators and study sites, processes Clinical Trial Data based on the protocol, and monitors the trial activities. CROs, partners and service providers (“third parties”) engaged by Xenon for the purposes of conducting a clinical trial.  All parties are required by law and contractual undertakings to:

  • Keep your Personal Information confidential and secure; and
  • To use and disclose it for purposes that a reasonable person would consider appropriate in the circumstances, in compliance with all applicable legislation.

Categories of third parties that Xenon engages for clinical trials include:

  • Wholly owned subsidiaries of Xenon 
  • Contract Research Organizations
  • Statistical Research Analysts
  • Clinical advisors
  • Technical providers for hosting and software services
  • Safety board/Adjudication committee
  • Healthcare providers who may be engaged to provide homecare services
  • Couriers or transport companies to enable us to deliver samples or drug product
  • Travel and insurance providers
  • Mobile data collection providers

The list of third parties that Xenon engages for a specific trial is available upon request.

Location of Clinical Trial Data

Xenon Pharmaceuticals Inc. is located in Canada. Clinical Trial Data is processed in Australia, Canada, the United States and other international jurisdictions based on your consent to do so, which is obtained on the Informed Consent Form.

Retention

Xenon will retain Clinical Trial Data and will instruct third parties to retain Personal Information or Clinical Trial Data, depending on their role in the study, subject to applicable legislation. In Canada the retention period for clinical trial data is 25 years under Canadian Food and Drug Regulations.  Pursuant to the Therapeutic Goods Administration, Australia requires that data is retained for at least 15 years after the trial is completed or discontinued.

Individual Access and Accuracy

Where Clinical Trial Participants have a right to access, correct or update Personal Information, Xenon will provide support to exercise those rights. Xenon may not be able to comply with a direct request where Xenon is not in a position to identify you. This would occur where Xenon has received Pseudonymized Data or where Personal Information has been destroyed, erased or made anonymous in accordance with our record retention obligations and practices.

Your rights related to the trial, including the right to withdraw consent, are described in the clinical trial Informed Consent Form.

Please contact the physician or hospital that enrolled you in the clinical trial if you would like to exercise your rights related to your Personal Information collected for clinical trial purposes.

Security Measures

We have taken appropriate technical and organizational security measures to protect Clinical Trial Data against unintentional or unlawful destruction, loss, alteration, unauthorized disclosure, unauthorized access, and any other unlawful or unauthorized forms of processing under applicable law. 

Such measures include, in particular, ensuring confidentiality, integrity and availability of data by controlling physical access to the data, as well as the relevant access, input, disclosure, security of availability and its separation. In addition, we take into account the protection of Clinical Trial Data when developing or selecting the hardware, software and procedures in line with the APPs, the principle of data protection through technology and privacy by design.

Questions and Complaints

When contacting Xenon regarding any issue, please do not include any personal information (other than your contact information) or health information in the subject line or in the content of the message.

You may contact our Privacy Officer with questions or complaints regarding this Privacy Notice and Xenon’s processing of Clinical Trial Data:

Gary Donaldson
200 – 3650 Gilmore Way
Burnaby, British Columbia
Canada V5G 4W8
E: privacy@xenon-pharma.com
T: (+1) 604-484-3337

Xenon will reply to complaints within 30 calendar days of their receipt and will attempt resolution in accordance with this Privacy Notice.

If our Privacy Officer is unable to resolve your concern, you may also contact the Office of the Australian Information Commissioner or the relevant Commissioner in your state or territory.

Last updated: January 21, 2022