We are committed to protecting your privacy.
This policy addresses how Travere Therapeutics ensures individuals’ privacy when conducting clinical trials. Travere Therapeutics will contract with service providers, such as Contract Research Organizations (“CROs”), or other service partners to collect and analyze clinical trial data. To enhance privacy, individual’s names and other direct identifiers are not attached to records or samples collected by Travere Therapeutics or our service providers during the research process.
You may contact us, Travere Therapeutics, Inc., via mail at 3611 Valley Centre Drive, Suite 300, San Diego, CA 92130, Attn: Chief Compliance Officer & Privacy, via email at firstname.lastname@example.org, or you can call us at +1-888-969-7879.
For the purposes of European Economic Area (“EEA”) and other data protection laws, Travere Therapeutics establishes the legitimate reasons to use an individual’s data for clinical trials and have established the means/methods of processing this data for research purposes. Chosen service partners, including CROs, are selected based on qualifications that include ensuring patient privacy. Travere Therapeutics maintains an audit schedule for approved vendors involved in the clinical trials and reviews privacy adherence during these inspections. CROs are often involved in managing patient data for clinical trials. Depending on the nature of each trial, Travere Therapeutics is either the controller or joint-controller of the processing operations associated with the clinical trial.
Patients enrolled in Travere Therapeutics clinical trials can contact the Company, as noted above, if there are questions related to how a patient’s data is being collected or processed within the trial.
“Personal data” or “data” is defined as any information related to an identified or identifiable individual. Depending on the context in which Travere Therapeutics processes personal data, Travere Therapeutics will collect and otherwise process:
The pseudonyms of trial subjects (unique codes assigned to every subject); Professional profiles, identification data and contact information of healthcare providers that participate in the trial as investigators; Information related to clinical trial execution by investigators and supporting staff during the trial; Financial disclosure information, CVs and medical licenses for principal and sub-investigators conducting the clinical research.
In the pre-trial phase, through the CROs, Travere Therapeutics collects identification and contact information of healthcare professionals that are considered for study participation. Travere Therapeutics collects this data from our own or the CROs’ databases, from public sources, referrals or third-party vendors.
Through the Company’s CROs, Travere Therapeutics collects, uses, stores, and analyzes data and bio-medical samples related to clinical trial subjects. The subjects’ names and other direct identifiers are not attached to records or samples. Instead, each subject is assigned a unique code (pseudonym). An individual’s identity is maintained by the clinical trial investigators and authorized study personnel at the clinical trial sites. Only authorized individuals including study staff, CROs, and monitors may access named subject records at the source under limited conditions.
As a trial sponsor, Travere Therapeutics may occasionally request access to certain data directly. Travere Therapeutics does so only when this is necessary to comply with legal obligations, legal requests from authorities or for accountability purposes.
Our Policy Towards Children
Some of Travere Therapeutics’ clinical trials involve participants that are children. Travere Therapeutics only processes a child’s personal data with parental consent or the consent of a legal representative and in accordance with the laws where the clinical trial is being conducted.
Travere Therapeutics processes the personal data enumerated above for the following purposes: Research; Identify potential investigators to participate in a clinical trial; Pharmacovigilance; Evaluating the patient recruitment performance of clinical research centers.
Travere Therapeutics’ clinical trials are conducted with the informed consent of the clinical trial participants.
In cases where applicable data protection laws require lawful bases for processing of personal data, such as processing in the EEA, United Kingdom and Switzerland, our lawful basis for processing may vary depending on the jurisdiction, the types of personal data being processed, and the nature of the processing being undertaken. In some cases, the clinical trial participant’s consent serves as our lawful basis for processing personal data, including health data and other categories of special/sensitive data. In other cases, our processing of personal data for research may be our legitimate interest as a controller in conducting research or our compliance with our legal obligations, including reliability and safety purposes in connection with our administration of clinical trials. Research for secondary research purposes typically is undertaken on the basis of the clinical trial participant’s consent.
Our processing of special/sensitive categories of personal data, including health data, biometric and genetic data, as well as any other sensitive information, such as race, ethnicity, sexual orientation and gender identity that may be collected pre-trial or revealed through the clinical trial, may be based on the legal bases of the clinical trial participants consent, for reasons of public interest in the area of public health, or for scientific purposes in accordance with applicable law.
Our processing of personal data about investigators and others in the clinical trial process (other than clinical trial participants) may be our legitimate interests as a controller, to comply with our legal obligations, or where necessary to enter into or carry out our agreements with clinical trial investigators or other persons/entities involved in the clinical trial process.
Due to the inherent sensitivity of the activity and information quality surrounding a clinical trial, access to personal data is very limited and it is granted on a “need to know” basis for the purpose of managing and conducting clinical trials. Travere Therapeutics will also give access to personal data following legal requests for access made by government and enforcement authorities, or to comply with any other legal requirement. Clinical trial auditors can also obtain access to personal data as necessary.
Travere Therapeutics takes reasonable steps to ensure that personal data is reliable for its intended use, accurate, complete, and is current. Travere Therapeutics also ensures personal data is limited to the information relevant for purposes of processing.
If a clinical trial participant is located outside the United States (“U.S.”) and participates in one of Travere Therapeutics’ clinical trials, their personal data would be transferred to the U.S.
If the clinical study participant is based in the EEA, United Kingdom or Switzerland, Travere Therapeutics utilizes standard contractual clauses or other lawful grounds for transfers of personal data to the U.S., such as the EU-U.S. Data Privacy Framework, as further outlined in this section.
Data Privacy Framework:
Travere Therapeutics complies with the EU-U.S. Data Privacy Framework (“EU-U.S. DPF”), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework (“Swiss-U.S. DPF”) as set forth by the U.S. Department of Commerce. Travere Therapeutics has certified to the U.S. Department of Commerce that it adheres to the EU-U.S. Data Privacy Framework Principles (“EU-U.S. DPF Principles”) with regard to the processing of personal data received from the European Union and the United Kingdom (and Gibraltar) in reliance on the EU-U.S. DPF and the UK Extension to the EU-U.S. DPF. Travere Therapeutics has certified to the U.S. Department of Commerce that it adheres to the Swiss-U.S. Data Privacy Framework Principles (“Swiss-U.S. DPF Principles”) with regard to the processing of personal data received from Switzerland in reliance on the Swiss-U.S. DPF. If there is any conflict between the terms in this policy and the EU-U.S. DPF Principles, and/or the Swiss-U.S. DPF Principles, the DPF Principles shall govern. To learn more about the Data Privacy Framework (“DPF”) program, and to view Travere Therapeutics’ certification, please visit https://www.dataprivacyframework.gov.
Resolution of Complaints:
In compliance with the EU-U.S. DPF, UK Extension to the EU-U.S. DPF, and the Swiss-U.S. DPF, Travere Therapeutics commits to resolve complaints about your privacy and our collection and use of your personal data transferred to the U.S. pursuant to the DPF Principles. EEA, UK and Swiss individuals with DPF inquiries or complaints should first contact Travere Therapeutics at:
Travere Therapeutics, Inc.
Attn: Chief Compliance & Privacy Officer
3611 Valley Centre Drive, Suite 300
San Diego, CA 92130
Or call: +1-888-969-7879
Or e-mail: email@example.com
Travere Therapeutics has further committed to refer unresolved privacy complaints under the DPF Principles to an independent dispute resolution mechanism, the International Centre for Dispute Resolution American Arbitration Association. If you do not receive timely acknowledgement of your DPF Principles-related complaint, or if your complaint is not satisfactorily addressed, please visit http://go.adr.org/dpf_irm.html for more information or to file a complaint. The services of the International Centre for Dispute Resolution American Arbitration Association are provided at no cost to you.
International Centre for Dispute Resolution – American Arbitration Association
Case Filing Services
877.495.4185: Toll free
If your DPF Principles-related complaint cannot be resolved through the above channels, under certain conditions, you may invoke binding arbitration for some residual claims not resolved by other redress mechanisms. See https://www.dataprivacyframework.gov/s/article/G-Arbitration-Procedures-dpf?tabset-35584=2.
If you are based in the EEA, United Kingdom or Switzerland, you may also choose to contact your local Data Protection Authority (“DPA”), the UK Information Commissioner’s Office (“ICO”), or the Swiss Federal Data Protection and Information Commissioner (“FDPIC”). Your DPA, the ICO or the FDPIC may refer your complaint directly to the U.S. Department of Commerce on your behalf. In this case, the Data Privacy Framework Team will then work to resolve your concern.
The Federal Trade Commission has jurisdiction over Travere Therapeutics’ compliance with the EU-U.S. DPF and the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. DPF.
In the context of an onward transfer, Travere Therapeutics has responsibility for the processing of personal data it receives under the Data Privacy Framework and subsequently transfers to a third party acting as an agent on its behalf. Travere Therapeutics shall require any third party to which it transfers personal data to adhere to the DPF Principles. Travere Therapeutics remains liable under the DPF Principles if its agent processes such personal data in a manner inconsistent with the DPF Principles unless Travere Therapeutics is not responsible for the event giving rise to the damage.
If clinical trial participants reside or otherwise find themselves in the territory of the EEA, United Kingdom or Switzerland, Travere Therapeutics is committed to facilitate the exercise of their rights granted by applicable data protection law in a timely manner – the right of clinical trial participants to access their data, to ask for erasure, correction, portability of their data or to object to the processing of their data. In order to be able to reply to their request and if Travere Therapeutics is not certain of the clinical patient’s identity, Travere Therapeutics may need to ask them for further identification data to be used only for the purposes of replying to the request. If the clinical trial participant has any inquiries, or would like to exercise any rights, they can contact us via this form or call us at +1-888-969-7879 and ask for the chief compliance and privacy officer.
For clinical trials, Travere Therapeutics will ensure contractually that the CROs provide all required support to comply with lawful requests made by persons whose data Travere Therapeutics controls or processes.
Travere Therapeutics does not use personal data to engage in automated decision-making as part of the clinical trial process.
Travere Therapeutics is committed to processing data in a secure manner. The Company has put in place specific technical and organizational measures to prevent research data from being accidentally or deliberately compromised, including requirements for high security standards from service providers contracted by Travere Therapeutics.
Clinical trial participants can withdraw consent at any time suspending further data collection efforts. All data collected and processed prior to the withdrawal of consent is lawful to be used by Travere Therapeutics.
Clinical trial participants can contact Travere Therapeutics’ Chief Compliance & Privacy Officer at firstname.lastname@example.org or via phone or postal mail as noted above to discuss concerns or questions about how their personal data is used, or if they want to exercise their rights granted under the applicable data protection law. Travere Therapeutics will promptly respond to address the concern.
Clinical trial participants may also choose to contact their local Data Protection Authority (“DPA”).
Clinical trial participants should also consider contacting their investigative site directly.
Travere Therapeutics reserves the right at any time, to modify, alter, or update this policy as warranted. The date of last revision is indicated by the date stamp on the policy.
This Policy was last updated on October 6, 2023.