Global Clinical Trial Site Personnel Privacy Notice

UNITED STATES

Last updated: January 21, 2025

Global Clinical Trial Site Personnel Privacy Notice

This Global Clinical Trial Site Personnel Privacy Notice applies to personal information Jazz Pharmaceuticals plc and its corporate subsidiaries and affiliates including GW Pharmaceuticals companies (collectively “Jazz Pharmaceuticals”, “we”, “us”, “our”) will process about you as a clinical investigator (principal investigators, sub-investigators or co-investigators) or site personnel (nurses, pharmacists or technicians, etc.), collectively (“Site Personnel”) in the course of the clinical trials and studies (“Clinical Study(ies)”) sponsored or organized by Jazz Pharmaceuticals. It explains how we collect, share and use your personal information, and how you can exercise your privacy rights.

Personal information means any information or piece of information which could identify you either directly (e.g. your name) or indirectly (e.g. a unique ID number).

As the sponsor of our Clinical Studies, we are responsible for handling your personal information and ensuring compliance with applicable data protection laws; in some countries this role is referred to as the Data Controller. Please refer to the study protocol or the study documentation to access the Jazz Pharmaceuticals entity that is responsible as sponsor for handling your personal information in the context of a particular study.

What personal information do we collect about you?   

We may collect the following personal information about you:

In anticipation and as part of your participation in our Clinical Studies we may collect the following personal information about you:

  • Contact information, such as name and work contact details (address, telephone number and email address).
  • Professional information, such as work experience, professional qualifications, registrations and memberships in associations and boards, scientific activities and publication of academic or scientific research and articles.
  • Financial information, such as payment-related information if you will be paid directly by us and/or the Contract Research Organization (CRO), financial disclosure as required by law.
  • Any other information that may be required for evaluation of potential study participation, management of the study and/or execution of contract(s).

How do we collect your personal information?  

In most cases we will obtain your personal information directly from you. You are not required to provide the requested personal information, however, failure to provide the information will result in you not being able to work on our Clinical Studies.

We may also receive personal information about you from other sources, which could include:

  • The research center where you work or conduct/support research activities;
  • Third parties with whom we collaborate or external sources providing us with your information; and
  • Publicly available sources such as websites including clinicaltrials.gov, www.clinicaltrialsregister.eu, the US FDA’s Debarment and Disqualified and Restricted Lists for clinical investigators.

How do we use your personal information?  

We may use your personal information for the following purposes:

  • Identifying and evaluating your site for potential study participation;
  • For the management of our Clinical Studies in accordance with applicable legislation in the context of clinical research;
  • To comply with legal, regulatory, industry best practices, and ethical obligations including without limitation applicable laws and industry codes imposing disclosure requirements for transfers of value made to healthcare professionals and healthcare organizations; pharmacovigilance data capture and reporting obligations;
  • To inform you, plan and/or conduct other Clinical Studies including to identify suitable investigators for our studies;
  • To share information with other companies or industry organizations in the context of planning and conducting Clinical Studies;
  • To enable patient recruitment;
  • To assess the effectiveness of the sites participating in our Clinical Studies;
  • To respond to your queries and provide you with information when you request it;
  • To reimburse you for expenses or pay you only where you are paid for work directly by us and/or the CRO; and
  • To exercise or defend us against potential, threatened or actual litigation.

Where a legal basis is required to justify how we use your personal information, we will process your personal information on the basis of:

  • a contractual necessity to obtain and prepare the necessary documentation to enter into a contract, and thereafter manage such relationship, with you and/or your institution;
  • our legitimate interest to publish contact details on clinical studies-related website, contact you for further study participation and sharing your information with other sponsors to facilitate research opportunities. You may object to such processing by contacting us through any of the methods listed in the “How to contact us” section below; and
  • applicable laws and international standards to keep your information for the conduct of Clinical Studies for evidence of qualifications of investigators and sub-investigators.

Where required by applicable laws, we will ask your prior consent for the processing, transfer or sharing

With whom do we share your personal information?  

We may need to share your personal information as follows to the extent necessary:

  • to our personnel and other Jazz Pharmaceuticals Group companies;
  • to suppliers and services providers acting on our behalf that provide services and products to us (e.g., CROs, laboratories, imaging vendor, etc.). These third parties are contractually obliged to protect the confidentiality and security of your personal information in compliance with applicable laws;
  • to the appropriate regulatory authorities (e.g., FDA), auditors and ethics committees, other enforcement agencies, commissions, courts including for purposes of complying with local laws, regulations or pharmaceutical industry codes, or conducting in-person or remote assessments;
  • to our partners and/or other sponsors (e.g. other pharmaceutical and medical device companies in the context of consortia or industry initiatives to facilitate research opportunities);
  • to other clinical investigators and/or site personnel as part of study related communications;
  • to any third party that acquires, or is interested in acquiring, all or part of Jazz Pharmaceuticals’ assets or shares, or that succeeds Jazz Pharmaceuticals in carrying on all or a part of its business, whether by merger, acquisition, reorganization or otherwise; or
  • as required or permitted by law, including to comply with a subpoena or similar legal process or government request, or when we believe in good faith that disclosure is legally required or we have a legitimate interest in making a disclosure, such as where necessary to protect our rights and property.

When do we transfer your personal information outside your home country?  

Given the global nature of Jazz Pharmaceuticals’ activities your personal information may be transferred to countries located outside your country or region, including to countries that may not provide a similar or adequate level of protection to that provided by your country or region. In such a case, we will implement appropriate measures to protect your personal information in accordance with the applicable data protection laws.

For example, if you are located in the European Economic Area (“EEA”), the United Kingdom (“UK”) or Switzerland, we may transfer your personal information to the United States or other countries outside of the EEA, UK or Switzerland. For the transfer of personal information from the EEA, UK or Switzerland to any countries not recognized by the European Commission, UK or Swiss governmental authorities as providing an adequate level of data protection according to EEA, UK or Swiss standards, we have implemented adequate measures to protect the personal information, such as by ensuring the recipient is bound by standard contractual clauses adopted by the European Commission, UK and Swiss governmental authorities.

All Jazz Pharmaceuticals’ entities have entered into an Interaffiliate Data Processing and Transfer Agreement including Standard Contractual Clauses to govern the transfer of personal information within Jazz Pharmaceuticals from the EEA, the UK and Switzerland to other countries including the United States.

How do we protect your personal information?   

The security of your personal information is important to us. We take reasonable steps, including technical, administrative and physical safeguards, designed to protect the personal information submitted to us from loss, misuse and unauthorised access, disclosure, alteration and destruction.

How long do we keep your personal information?   

Your personal information will be maintained for no longer than is necessary to fulfil the purposes outlined in this Notice. We will store and retain your Personal Information in accordance with applicable laws and our Information Governance Policy. Please note that in certain countries we may be required to retain Clinical Study Documentation for a minimum of 25 years.

What are your rights regarding your personal information?   

Where the legislation of your country gives you the right to access, verify your personal information held by us, receive a copy of it, object, restrict, request its deletion or correction and object to certain processing, you can exercise your rights by contacting us through any of the methods listed in the “How to contact us” section below.

Please note that due to the nature of the processing for scientific research purposes, not all of the rights that may be stated in law will be available to you. For example, personal information cannot be erased at the end of your involvement with the clinical study. If you withdraw from working on the clinical study, personal information collected up to your departure will be retained and processed to comply with legal obligations under applicable clinical study legislation, but no further personal information will be collected.

We will consider any request and advise you if it is possible without affecting the Clinical Study data integrity.

You may also have a right to lodge a complaint directly with the local data protection authority where you live, work or where an alleged infringement has occurred.

How to contact us   

If you have any questions, comments or suggestions about this Privacy Notice or our privacy practices, please contact the Jazz Pharmaceuticals Privacy Office at:

Address: 3170 Porter Drive, Palo Alto, CA 94303, U.S.                                 
Tel.: (650) 496-3777                                 
Email: privacy@jazzpharma.com

For UK, Swiss and European purposes, our Data Protection Officer can be reached at dpo@jazzpharma.com.

How do we update this Privacy Notice?   

We may update this Privacy Notice from time to time and will provide notice of such changes by updating the “Last Updated” date listed on this Privacy Notice. If changes are significant, we will provide a more prominent notice to let you know what the changes are.