SPRI Privacy Shield Policy

SPRI Clinical Trials – Global, LLC ("SPRI") has adopted this Privacy Shield Policy ("Policy") to establish and maintain an adequate level of Personal Data privacy protection. This Policy applies to the processing of Personal Data that SPRI obtains from Clients or Vendors, hereinafter referred to simply as Clients.

SPRI complies with the US-EU Privacy Shield Framework as set forth by the US Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries. SPRI has certified that it adheres to the Privacy Shield Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement. If there is any conflict between the policies in this privacy policy and the Privacy Shield Privacy Principles, the Privacy Shield Privacy Principles shall govern. To learn more about the Privacy Shield program, and to view our certification page, please visit https://www.privacyshield.gov.

All SPRI employees who handle Personal Data from Europe are required to comply with the Principles stated in this Policy.

Capitalized terms are defined in Section 14 of this Policy.

I. SCOPE

This Policy applies to Client Personal Data that SPRI receives in the United States concerning Clients who reside in Europe. SPRI provides clinical trial services to study sponsors. Personal Data collected by SPRI is limited to contact information of Client employees, agents and contractors who are working with SPRI on the Client study. This Policy does not cover data from which individual persons cannot be identified including situations in which data is key-coded. (The use of key-codes involves the replacement of names or other identifiers with substitutes so that identification of individual persons is not possible.)

II. RESPONSIBILITIES AND MANAGEMENT

SPRI has designated an internal team to oversee its information security program, including its compliance with the Privacy Shield program. The internal team shall review and approve any material changes to this program as necessary. Any questions, concerns, or comments regarding this Policy also may be directed to privacyshield@spriclinicaltrials.com.

SPRI will maintain, monitor, test, and upgrade information security policies, practices, and systems to assist in protecting the Personal Data that it collects. SPRI personnel will receive training, as applicable, to effectively implement this Policy. Please refer to Section 7 for a discussion of the steps that SPRI has undertaken to protect Personal Data.

III. RENEWAL / VERIFICATION

SPRI will renew its Privacy Shield certification annually, unless it subsequently determines that it no longer needs such certification or if it employs a different adequacy mechanism.

Prior to the re-certification, SPRI will conduct an in-house verification to ensure that its attestations and assertions with regard to its treatment of Client Personal Data are accurate and that the company has appropriately implemented these practices. Specifically, as part of the verification process, SPRI will undertake the following:

  • Review this Privacy Shield policy and its publicly posted website privacy policy to ensure that these policies accurately describe the practices regarding the collection of Client Personal Data
  • Ensure that the publicly posted privacy policy informs Clients of SPRI's participation in the Privacy Shield program and where to obtain a copy of additional information (e.g., a copy of this Policy)
  • Ensure that this Policy continues to comply with the Privacy Shield principles
  • Confirm that Clients are made aware of the process for addressing complaints and any independent dispute resolution process (SPRI may do so through its publicly posted website, Client contract, or both)
  • Review its processes and procedures for training Employees about SPRI's participation in the Privacy Shield program and the appropriate handling of Client Personal Data
IV. COLLECTION AND USE OF PERSONAL DATA

SPRI provides various solutions to its Clients, which are business Clients, typically biotech companies, pharmaceutical companies or other Contract Research Organizations. SPRI collects Personal Data from Clients when they, request information on our website, request information from us, or otherwise communicate with us.

The Personal Data that we collect may vary based on the Client's interaction with us. As a general matter, SPRI collects the following types of Personal Data from its Clients: contact information, including, a contact person's name, work email address, work mailing address, work telephone number, title, and company name.

SPRI serves as a service provider to its Clients. In our capacity as a service provider, we will receive, store Personal Data owned and/or controlled by our Clients, including information about their employees, their clients, agents, or other individuals. The information that we collect from our Clients in this capacity is used for managing transactions, reporting, invoicing, other operations related to providing services to the Client, and as otherwise requested by the Client.

SPRI uses Personal Data that it collects directly from its Clients and Clients' Clients indirectly in its role as a service provider for the following business purposes, without limitation: (1) delivering and providing the requested services and complying with its contractual obligations related thereto (including managing transactions, reporting, invoices, and other operations related to providing services to a Client); (2) satisfying governmental reporting, tax, and other requirements; (3) storing data, including Personal Data, in computer databases and servers located in the United States; (4) as requested by the Client; (5) for other business-related purposes permitted or required under applicable local law and regulation; and (6) as otherwise required by law.

V. DISCLOSURES / ONWARD TRANSFERS OF PERSONAL DATA

Except as otherwise provided herein, SPRI discloses Personal Data only to Third Parties who reasonably need to know such data. Such recipients must agree to abide by confidentiality obligations. Examples of Third Parties that may receive personal information include subcontractors or consultants that have been contracted on behalf of our Client (with which we are contracted) and will only be provided with advance written notice. Third Parties receiving personal information must have a written confidentiality agreement in place between Client and Third Party and/or SPRI and Third Party that meets or exceeds Privacy Shield standards. Exceptions to this requirement are described below.

SPRI may provide Personal Data to Third Parties that act as agents, consultants, and contractors to perform tasks on behalf of and under our instructions. For example, SPRI may provide contact information allowing the Third Party to work directly with a Client employee. Such Third Parties must agree to use such Personal Data only for the purposes for which they have been engaged by SPRI and they must either: (1) comply with the Privacy Shield principles or another mechanism permitted by the applicable European data protection law(s) for transfers and processing of Personal Data; or (2) agree to provide adequate protections for the Personal Data that are no less protective than those set out in this Policy. Typically, the Personal Data collected by SPRI is the contact information of Client employees, agents, consultants and contractors.

SPRI also may disclose Personal Data for other purposes or to other Third Parties when a Data Subject has consented to or requested such disclosure, or in certain other instances where the fulfillment of Client contractual obligations dictates such disclosure. Examples of the latter case may include contact information provided to a courier or vendor for the delivery of work related documents or supplies. Individuals may opt out of these disclosures in accordance with section X.4 of this policy.

SPRI may be forced to disclose an individual's personal information when compelled by a request made by a recognized public authority or where required to meet national security and or law enforcement requirements.

In cases of onward transfer to third parties of data of EU individuals received pursuant to the EU-US Privacy Shield, SPRI is potentially liable. SPRI's liability under this agreement will be governed by the contract in place between Client and SPRI.

VI. SENSITIVE DATA

SPRI does not collect Sensitive Data from its Clients.

VII. DATA INTEGRITY AND SECURITY

As the Personal Data maintained by SPRI is usually contained in e-mail signatures and executed agreements stored on our servers, any updates will only be made on a prospective basis. SPRI has implemented physical and technical safeguards to protect Personal Data from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. For example, electronically stored Personal Data is stored on a secure network with firewall protection, and access to SPRI's electronic information systems requires user authentication via password or similar means. SPRI also employs access restrictions, limiting the scope of employees who have access to Client Personal Data.

Despite these precautions, no data security safeguards guarantee 100% security all of the time.

VIII. NOTIFICATION

SPRI notifies Clients about its adherence to the Privacy Shield principles within individual contracts and/or master services agreements.

IX. ACCESSING PERSONAL DATA

SPRI personnel may access and use Personal Data only if they are authorized to do so and only for the purpose for which they are authorized.

X. RIGHT TO ACCESS, CHANGE OR DELETE PERSONAL DATA
  • Right to Access. As a Client of SPRI, you have the right to access your data at any time. Data subjects have the right to know what Personal Data about them is included in the databases and to ensure that such Personal Data is accurate and relevant for the purposes for which SPRI collected the Personal Data. Data Subjects may review their own Personal Data stored in the databases and correct, erase, or block any data that is incorrect, as permitted by applicable law. Upon reasonable request and as required by the Privacy Shield principles, SPRI allows Clients access to their Personal Data, in order to correct or amend such data where inaccurate. Note that Data included in archived emails, study Trial Master Files and other study related documents may be contained in un-editable files and that information may only be corrected on a prospective basis.
  • Requests for Personal Data . SPRI will track each of the following and will provide notice to the appropriate parties under law and contract when either of the following circumstances arise: (a) legally binding request for disclosure of the Personal Data by a law enforcement authority unless prohibited by law or regulation; or (b) requests received from the Data Subject. If SPRI receives a request for access to his/her Personal Data from a Client's Client, then, unless otherwise required under law or by contract with such Client, SPRI will refer such Data Subject to Client.
  • Satisfying Requests for Access, Modifications, and Corrections. SPRI will endeavor to respond in a timely manner to all reasonable written requests to view, modify, or inactivate Personal Data.
  • Limiting Use of Personal Data. You may request limitations on the use of your personal data specified in this agreement by contacting us at privacyshield@spriclinicaltrials.com.

Clients may edit their Personal Data by contacting SPRI by phone or email. In making modifications to their Personal Data, Data Subjects must provide only truthful, complete, and accurate information. To request erasure of Personal Data, Clients should submit a written request to their local SPRI office. Persons that have submitted their Personal Data to a SPRI Client should contact the Client in the first instance to update their data.

XI. CHANGES TO THIS POLICY

This Policy may be amended from time to time, consistent with the Privacy Shield Principles and applicable data protection and privacy laws and principles. We will make employees aware of changes to this policy either by posting to our intranet, through email, or other means. We will notify Clients if we make changes that materially affect the way we handle Personal Data previously collected, and we will allow them to choose whether their Personal Data may be used in any materially different manner.

XII. QUESTIONS OR COMPLAINTS

Clients may contact SPRI with questions or complaints concerning this Policy at the following address privacyshield@spriclinicaltrials.com.

XIII. ENFORCEMENT AND DISPUTE RESOLUTION

Clients with questions or concerns about the use of their Personal Data should contact us at privacyshield@spriclinicaltrials.com. In compliance with the Privacy Shield Principles, SPRI commits to resolve complaints about our collection or use of your personal information. Individuals in the European Union with inquiries or complaints regarding our Private Shield policy should first contact privacyshield@spriclinicaltrials.com. SPRI has further committed to refer unresolved privacy complaints under the EU-US Privacy Shield Principles to BBB EU PRIVACY SHIELD, a non-profit alternative dispute resolution provider located in the United States and operated by the Council of Better Business Bureaus. If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed, please visit http://www.bbb.org/EU-privacy-shield/for-eu-consumers/ for more information and to file a complaint.

Finally, and as a last resort, EU individuals with unresolved privacy complaints may, under limited circumstances, appeal to the Privacy Shield Panel, a binding arbitration mechanism.

As part of this agreement, SPRI subjects itself to the investigatory and enforcement powers of the Federal Trade Commission (FTC).

XIV. DEFINITIONS

Capitalized terms in this Privacy Policy have the following meanings:

"Client" means a prospective, current, or former, vendor, supplier, or customer of SPRI. The term also shall include any individual agent, employee, representative, or customer of an SPRI Client where SPRI has obtained his or her Personal Data from such Client as part of its business relationship with the Client.

"Data Subject" means an identified or identifiable natural living person. An identifiable person is one who can be identified, directly or indirectly, by reference to a name, or to one or more factors unique to his or her personal physical, psychological, mental, economic, cultural or social characteristics. For Clients residing in Switzerland, a Data Subject also may include a legal entity.

"Employee" means an employee (whether temporary, permanent, part-time, or contract), former employee, independent contractor, or job applicant of SPRI or any of its affiliates or subsidiaries, who is also a resident of a country within the European Economic Area.

"Europe" or "European" refers to a country in the European Economic Area.

"Personal Data" as defined under the European Union Directive 95/46/EC means data that personally identifies or may be used to personally identify a person, including an individual's name in combination with country of birth, marital status, emergency contact, salary information, terms of employment, job qualifications (such as educational degrees earned), address, phone number, e-mail address, user ID, password, and identification numbers. Personal Data does not include data that is de-identified, anonymous, or publicly available. For Switzerland, the term "person" includes both a natural person and a legal entity, regardless of the form of the legal entity.

"Sensitive Data" means Personal Data that discloses a Data Subject's medical or health condition, race or ethnicity, political, religious or philosophical affiliations or opinions, sexual orientation, or trade union membership.

"Third Party" means any individual or entity that is neither SPRI nor a SPRI employee, agent, contractor, or representative.