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Adult’s Chronic Spontaneous Urticaria Study (24 Weeks)

For condition: Chronic Spontaneous Urticaria
For condition: Urticaria
Enrolling:
B7981118

Adult’s Chronic Spontaneous Urticaria Study (24 Weeks)

Study Summary

Who Can Participate?
Adults aged 18 and above with chronic spontaneous urticaria (CSU) may participate.

Inclusion Criteria
• Chronic spontaneous urticaria diagnosis for ≥3 months
• Presence of itch and hives for ≥6 consecutive weeks

Participant Information
• Participate and receive study treatment at no cost
• Regular visits with study doctors who specialise in treating chronic spontaneous urticaria (10 visits)
• Will receive either an investigative oral treatment (study drug) or a placebo
• Reimbursement for study-related expenses may be provided

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For more information about this trial, please visit ClinicalTrials.gov

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Privacy Policy

Last Revised: July 2024

Introductions

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Probity complies with the Personal Information Protection and Electronic Documents Act (“PIPEDA”) and other applicable privacy and health information legislation. One of the underlying principles of this legislation is to obtain your consent in order to collect, use or disclose your Personal Information (defined below), and to ensure that you clearly understand the policies and practices regarding how this information is handled.

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Medical condition or area of interest; and
Your location (Country, City, State or Province, Zip Code or Postal Code);

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You may withdraw this consent at any time or update your information. To withdraw your consent or to update your information, contact the Privacy Officer by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

How do we Use and Disclose Personal Information?

Probity collects your Personal Information for the following purposes (the “Purposes”):

to identify you;
to contact you about clinical research studies;
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to confirm if your registration on ResearchTrials.com resulted in enrollment in any clinical trial, as well as the specific clinical trial(s) you enrolled in;
to ensure that we are achieving our goal of aiding enrollment in clinical trials;
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to comply with legal requirements.

For Patients, the information you submit on ResearchTrials.com will be used for the above purposes. Because the clinical research sites are located in different countries, your personal information may be transmitted to your nearest research site (or research site you selected).

That research site may be in a different country than the location of the ResearchTrials.com database.

For Sponsors and Physicians, the information you submit on ResearchTrials.com will be used to contact you.

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Probity is aware of your concern for privacy when using ResearchTrials.com. Probity takes reasonable steps to protect your Personal Information as you transmit your information from your computer to our websites and to protect your information from loss, misuse and unauthorized access, disclosure, alteration or destruction. All information transmitted to our website is secured using industry standard physical, technical, and administrative safeguards to secure data against foreseeable risks such as unauthorized use, access, disclosure, destruction, and modification. You should keep in mind, however, that no Internet transmission is ever 100% secure or error-free. In particular, e-mail sent to or from our website may not be secure, and you should therefore take special care in deciding what information you send to us via email.

Your Personal Information is kept in strict confidence; Probity utilizes appropriate security safeguards to keep your information confidential and secure. Only authorized personnel have access to your Personal Information and we do not release your Personal Information to third parties other than those third parties that are necessary to satisfy the Purposes (as defined above) for which the Personal Information was collected, including third party service providers. While we cannot guarantee that errors, loss or unauthorized access to your Personal Information will not occur, our procedures and systems are designed to protect your Personal Information from such events. When your Personal Information is no longer required to fulfill the identified Purposes, the information will be destroyed, erased, or made anonymous.

When you are contacted by a third party to participate in a clinical research study, Probity is no longer involved or responsible for collecting or safeguarding any further Personal Information you may provide to that third party.  As such, we recommend that you obtain information regarding their privacy policies before participating.

As we expect the need for participants in clinical research studies to be ongoing, the Personal Information you provide will be kept indefinitely. If at any time you wish to remove or update your information from our database, please contact our Privacy Officer by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

Access to Records and Other Information

Patients, Physicians and Sponsors have a right of access to their own Personal Information in a record that is in the custody or under the control of Probity, subject to some exceptions set out in applicable legislation. For example, organizations are required under PIPEDA to refuse to provide access to information that would reveal Personal Information about another individual. Further, organizations are authorized under PIPEDA to refuse access to Personal Information if disclosure would reveal confidential business information. Access may also be refused if the information is privileged or the information was generated in the course of a formal dispute resolution process.

If access is refused, in whole or in part, Probity will provide the reasons for the refusal. In cases where exceptions to access apply, Probity may withhold that information but will provide you with the remainder of the record.

If at any time you wish to access your personal information held by us, please contact us by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

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Probity may also collect non-personally identifiable information in aggregate form to track data such as the total number of visits to our websites, the number of visitors to each page of our websites, and the domain names of our visitors’ Internet service providers. We may use this information, which remains in aggregate form, to understand how our visitors use our websites so that we may make the websites better.

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Probity may also use “cookies” to administer our website, which are text packets sent by a server to a user’s web browser and then sent back unchanged by the user’s browser each time it accesses that server. Cookies are used for authenticating, tracking, and maintaining specific information about users, such as website preferences.  No personally identifiable information is exchanged via cookies.

Changes to the Policy

Probity reserves the right to modify or amend this Privacy Policy without notice and at any time and for any reason. An up-to-date version of this Privacy Policy may be obtained on our website.

Governing Law

This Privacy Policy is governed by the laws of Canada.  By submitting Personal Information to us, you understand that your Personal Information will be subject to the laws of Canada.

Questions and Concerns

You have the right to know how we protect your privacy and what you should expect from us. If you have questions or a complaint, you may contact our Privacy Officer by mail at:

Probity Medical Research Inc.
Attention: Privacy Officer
139 Union Street East
Waterloo, Ontario, Canada N2J 1C4

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