On 16 July 2020, the Court of Justice of the European Union (“CJEU”) invalidated the EU-US Privacy Shield in Case C-311/18 Data Protection Commissioner v Facebook Ireland Limited and Maximillian Schrems (“Schrems II”). This decision applies to data transfers from the EU (inclusive of the UK) to the United States in reliance on the Privacy Shield Framework. On 08 September 2020, the Federal Data Protection and Information Commissioner (FDPIC) of Switzerland also declared its position that the Swiss-U.S. Privacy Shield did not provide an adequate level of protection for the transfer of personal data from Switzerland to the United States under the Federal Act on Data Protection. In light of these developments, Worldwide is no longer relying on Privacy Shield for international transfers from the EEA or Switzerland to the United States and is instead relying on alternative transfer mechanisms for such transfers. Nevertheless, Worldwide continues to remain committed to the principles of the Privacy Shield for so long as it remains certified to this framework with the US Department of Commerce.
Privacy Shield Policy
This Privacy Shield Policy (”Policy”) describes how Worldwide Clinical Trials Holdings, Inc. and its subsidiaries and affiliates in the United States (“Worldwide US”) (”Company,” “we,” or “us”) collect, use, and disclose certain personally identifiable information that we receive in the US from the European Economic Area (”EEA”), the United Kingdom (”UK”), and Switzerland (”Personal Data”). This Policy applies to all US affiliated entities using the brand name “Worldwide Clinical Trials”, including, but not limited to Worldwide Clinical Trials Holdings, Inc., Worldwide Clinical Trials, Inc., Worldwide Clinical Trials Early Phase Services/Bioanalytical Sciences, LLC., Worldwide Clinical Trials Early Phase Services, LLC, and International Grants Administration, Inc. This Policy supplements our Global Privacy Statement and Online Privacy Statement, and unless specifically defined in this Policy, the terms in this Policy have the same meaning as the Global Privacy Statement.
Worldwide US recognizes that the EEA, the UK, and Switzerland have established strict protections regarding the handling of Personal Data, including requirements to provide adequate protection for Personal Data transferred outside of the EEA, the UK, and Switzerland. To provide adequate protection for certain Personal Data about clinical trial participants (including prospective participants), clients, healthcare professionals, investigator site personnel, service providers, suppliers, business partners, government officials, job applicants, and employees received in the US from the EEA, the UK, and Switzerland, Worldwide US has elected to self-certify to the EU-US Privacy Shield Framework and the Swiss-US Privacy Shield Framework administered by the US Department of Commerce (”Privacy Shield”). Worldwide US adheres to the Privacy Shield Principles of Notice, Choice, Accountability for Onward Transfer, Security, Data Integrity and Purpose Limitation, Access, and Recourse, Enforcement, and Liability. Adherence to the Privacy Shield Principles may be limited to the extent required or permitted under applicable law, rule or regulation. Also this Privacy Shield Policy may not apply where we transfer your Personal Data using an alternative transfer mechanism, such as Standard Contractual Clauses, or transfer your data as necessary for the performance of a contract you hold with Worldwide.
Personal Data Collection, Purposes and Use
We may receive the following categories of Personal Data in the US:
- Clinical Trial Related Personal Data: Personal Data may be collected from clients, personnel, patients (including spouses, caregivers and legal guardians), investigator site personnel, healthcare providers, service providers, suppliers and business partners for Worldwide to carry out business, operational, and safety activities related to a clinical trial or research study. Such Personal Data may be disclosed to other entities participating in the study, including the sponsor of the study, investigative sites, and third-party services providers and suppliers.
- Human Resources Personal Data: Personal Data may be collected from job applicants, actual or past employees, consultants or independent contractors, in order to fulfil our Human Resources (HR) functions and administer potential, past or current employment with Worldwide. Such Personal Data may be disclosed to Worldwide’s agents providing recruitment or employment services on our behalf.
- Business Contact Personal Data: Personal Data may be collected from clients, service providers, suppliers, and business partners in order to discuss prospective business opportunities, Worldwide’s service offerings, or provide customer support.
- Prospective Study Personal Data: Personal Data may be collected from prospective study participants, including patients or healthy volunteers, in order to determine interest or eligibility to participate in a clinical research study. Such Personal Data may be disclosed to other entities participating in prospective studies, including the sponsor of the study, investigative sites, and third-party services providers and suppliers.
- Web Visitor Personal Data: Worldwide collect Personal Data from website visitors and mobile app users in accordance with, and for the purposes described in our Online Privacy Statement.
Worldwide will only process Personal Data in ways that are compatible with the purpose that Worldwide collected it for, or for purposes the individual later authorizes. Before we use your Personal Data for a purpose that is materially different than the purpose we collected it for or that you later authorized, we will provide you with the opportunity to opt out. Worldwide maintains reasonable procedures to help ensure that Personal Data is reliable for its intended use, accurate, complete, and current.
Worldwide may collect and use sensitive Personal Data including government issued ID numbers, financial account information and reports of individual background information. Worldwide may also process sensitive Personal Data pertaining to race, ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic data, biometric data where processed to uniquely identify a person, or that concerns medical or health conditions or sex life. When we collect sensitive Personal Data, we will obtain your opt-in consent where the Privacy Shield requires, including if we disclose your sensitive Personal Data to third parties, or before we use your sensitive Personal Data for a different purpose than we collected it for or than you later authorized. In addition, Worldwide will treat as sensitive Personal Data any information received from a third party where that third party treats and identifies the information as sensitive.
Other transfer mechanisms: This Privacy Shield Policy may not apply or may be limited where your Personal Data is transferred on the basis of other approved transfer mechanisms, including Standard Contractual Clauses approved by the European Commission or when necessary for the performance of a contract between Worldwide and an individual.
Data Transfers to Third Parties
Third-Party Agents or Service Providers. We may transfer Personal Data to our third-party agents or service providers who perform functions on our behalf as described in our Global Privacy Statement. Where required by the Privacy Shield, we enter into written agreements with those third-party agents and service providers requiring them to provide the same level of protection the Privacy Shield requires and limiting their use of the data to the specified services provided on our behalf. We take reasonable and appropriate steps to ensure that third-party agents and service providers process Personal Data in accordance with our Privacy Shield obligations and to stop and remediate any unauthorized processing. Under certain circumstances, we may remain liable for the acts of our third-party agents or service providers who perform services on our behalf for their handling of Personal Data that we transfer to them.
Third-Party Data Controllers. In some cases, we may transfer Personal Data to unaffiliated third-party data controllers. These third parties do not act as agents or service providers and are not performing functions on our behalf. We may transfer your Personal Data to third-party data controllers for the purposes described in our Global Privacy Statement. We will only provide your Personal Data to third-party data controllers where you have not opted-out of such disclosures, or in the case of sensitive Personal Data, where you have opted-in if the Privacy Shield requires consent. We enter into written contracts with any unaffiliated third-party data controllers requiring them to provide the same level of protection for Personal Data the Privacy Shield requires. We also limit their use of your Personal Data so that it is consistent with any consent you have provided and with the notices you have received. If we transfer your Personal Data to one of our affiliated entities within our corporate group, we will take steps to ensure that your Personal Data is protected with the same level of protection the Privacy Shield requires.
Disclosures for National Security or Law Enforcement. Under certain circumstances, we may be required to disclose your Personal Data in response to valid requests by public authorities, including to meet national security or law enforcement requirements.
Worldwide maintains reasonable and appropriate security measures to protect Personal Data from loss, misuse, unauthorized access, disclosure, alteration, or destruction in accordance with the Privacy Shield.
You may have the right to access the Personal Data that we hold about you and to request that we correct, amend, or delete it if it is inaccurate or processed in violation of the Privacy Shield. These access rights may not apply in some cases, including where providing access is unreasonably burdensome or expensive under the circumstances or where it would violate the rights of someone other than the individual requesting access. If you would like to request access to, correction, amendment, or deletion of your Personal Data, you can submit a written request to the contact information provided below. We may request specific information from you to confirm your identity. In some circumstances we may charge a reasonable fee for access to your information.
Questions or Complaints
You can direct any questions, access requests or complaints about the use or disclosure of your Personal Data to us at:
Worldwide Clinical Trials
Attention: Global Data Protection Officer
600 Park Offices Drive, Suite 200
Research Triangle Park, NC 27560
We will investigate and attempt to resolve any complaints or disputes regarding the use or disclosure of your Personal Data within 45 days of receiving your complaint.
For any unresolved complaints relating to non-Human Resources Personal Data, we have agreed to cooperate with the panel established by the EU data protection authorities (“DPA Panel”), the UK Information Commissioner, or the Swiss Federal Data Protection and Information Commissioner as applicable and to comply with any advice given by the DPA Panel (or Commissioner, as applicable) with regard to your Personal Data. You may make use of this dispute resolution mechanism by contacting your local data protection authority using the links provided below. This service is provided free of charge to you.
For any unresolved complaints relating to Human Resources Personal Data, we have agreed to cooperate with the state or national data protection or labor authority in the appropriate jurisdiction. You may make use of this dispute resolution mechanism by contacting your local data protection authority using the links provided below. This service is provided free of charge to you.
Contact details for the EU data protection authorities, the UK Information Commissioner, or the Swiss Federal Data Protection and Information Commissioner as applicable at:
EU Data Protection Authorities: https://edpb.europa.eu/about-edpb/board/members_en
UK Information Commissioner: https://ico.org.uk/make-a-complaint/
Swiss Data Protection and Information Commissioner: https://www.edoeb.admin.ch/edoeb/en/home/the-fdpic/contact.html
Binding Arbitration You may have the option to select binding arbitration for the resolution of your complaint under certain circumstances, provided you have taken the following steps: (1) raised your compliant directly with Worldwide and provided us the opportunity to resolve the issue; (2) made use of the DPA Panel (or local data protection or labor authorities as applicable); and (3) raised any still-unresolved complaints through the relevant data protection authority and allowed the US Department of Commerce an opportunity to resolve the complaint at no cost to you. For more information on binding arbitration, see US Department of Commerce’s Privacy Shield Framework: Annex I (Binding Arbitration) https://www.privacyshield.gov/article?id=ANNEX-I-introduction.
Where Worldwide is processing Personal Data on behalf of a data controller (for example, as a CRO on behalf of client or sponsor), you may submit complaints concerning the processing of Personal Data to the relevant controller, in accordance with the controller’s dispute resolution process. Worldwide will act according to the instructions of and contractual terms in place with the data controller to support the data controller’s obligations under the Recourse, Enforcement and Liability principle. Worldwide will participate in this process at the request of the client or the Individual. Worldwide will take steps to remedy any issues arising out of potential failure to comply with the Privacy Shield Principles.
Changes to this Policy
We reserve the right to amend this Policy from time to time consistent with the Privacy Shield’s requirements.
Effective Date: 07April2020
Last modified: 18May2020