|We self-certify compliance with|
Version 1.0 - Date effective 10 July 2015
TFS is a global contract research organisation. TFS provides a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries.
TFS privacy statement
TFS complies with the U.S.-EU Safe Harbor Framework and the U.S.-Swiss Safe Harbor Framework as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information from European Union member countries and Switzerland. TFS has certified that it adheres to the Safe Harbor Privacy Principles of notice, choice, onward transfer, security, data integrity, access, and enforcement.
To learn more about the Safe Harbor program, and to view TFS’s certification, please visit http://www.rackspace.com/information/legal/privacystatement/safeharbor
Any third party that uses personal information provided by TFS to perform tasks on behalf of and under the instructions of TFS.
Any natural person located in the European Union or Switzerland whose personal information is shared with TFS in the United States.
Personal Information or Information
Information that (1) is transferred from the EU or Switzerland to the United States; (2) is recorded in any form; (3) is about, or pertains to a specific individual; and (4) can be linked to that individual. Personal information does not include information that is anonymized or pseudonymized such that an individual cannot be identified.
The enumerated principles outlined in the Safe Harbor Framework, which must be followed in order for an organization to be certified under the Safe Harbor Framework.
Sensitive Personal Information
Personal information that reveals race, ethnic origin, sexual orientation, political opinions, religious or philosophical beliefs, trade union membership or that concerns an individual’s health.
TFS shall inform an individual of the purpose for which it collects and uses the personal information and the types of non-agent third parties to which TFS discloses or may disclose that information. TFS shall provide the individual with the choice and means for limiting the use and disclosure of their personal information. Notice will be provided in clear and conspicuous language when individuals are first asked to provide personal information to TFS, or as soon as practicable thereafter, and in any event before TFS uses or discloses the information for a purpose other than for which it was originally collected.
Where TFS receives personal information from its subsidiaries, affiliates or other entities in the EU or Switzerland, including when acting as a CRO processing personal information under the direction of a customer, it will use such information in accordance with the notices provided by such entities and the choices made by the individuals to whom such personal information relates.
TFS may not need to furnish notice where the processing in question is necessary to respond to a government inquiry; is required / authorized by applicable laws, court orders or government regulations; or is necessary to protect TFS’ legal interests and providing notice would interfere with the above requirements.
What types of personal information does TFS collect and handle and for what purposes?
Clinical and Medical Information
As a global contract research organization, we collect, host and analyse health data relating to clinical trial subjects, on behalf of our clients. To enhance privacy, consistent with GCP, subjects’ names and other direct identifiers are not attached to any records collected by TFS for research purposes. Instead, subjects are only identified by a code (information is anonymized or pseudonymized). Only study doctors and authorized personnel, including TFS monitors and TFS auditors, may access named subject records at the investigational site. In certain cases where local law allows, TFS may collect full date of birth attached to study records. We maintain that this indirect identifier can on occasion serve to verify subject identity to the benefit of patient safety. All clinical and medical information processed by TFS is done so under contract with our clients. In terms established by the Directive (95/46/EC), TFS considers that the sponsor/client is ultimately in control of how and why clinical and medical data are processed within our services and as such is the “controller,” whilst TFS and its affiliates are “processors.”
Health professional information
TFS collects the professional profiles (CVs) of doctors and other health care providers for the purpose of identifying potential investigators to assist in clinical and medical research on specific indications. TFS will use available contact information, including email addresses, for the purpose of inviting potential investigators to apply to participate in research. TFS will source health professional information from its own databases and also indirectly from public sources and referrals. For operational purposes, TFS will also collect information relating to the involvement and performance of investigators and supporting study staff. TFS will also process financial information of investigators to support payment for services.
Employee and Human Resource data
TFS collects personal information from applicants to open positions within TFS, including private contact details, professional qualifications and previous employment history to inform employment decisions. TFS conducts various background checks on applicants, including, where law allows, on criminal history and professional disbarment. Once employed, TFS collects information on staff for human resource, performance, payroll and tax purposes. Various TFS internal systems will collect and record employee information consistent with standard business operations. TFS processes similar information relating to consultants contracted on a freelance basis.
TFS collects named information about visitors to TFS websites where this is voluntarily provided to meet a request from those individuals, for example where a client requests information on a TFS service, a health care professional is interested in participating in a clinical trial or where someone wants to apply for a vacant position with TFS. Through the use of cookie-based technologies, TFS may collect various data linked to virtual identities allocated to visitors when they access our websites. This data is used for various purposes, including site analytics and first party marketing. In certain cases, these virtual identities are linked to the real world identities of visitors when they provide their named information as described above.
TFS will offer individuals the opportunity to choose whether their personal information is (1) to be disclosed to a third party or (2) to be used for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual. Unless required or authorized by law, TFS will not process sensitive personal information about individuals for purposes other than those for which the information was originally obtained or subsequently authorized by the individual unless the individual affirmatively and explicitly consents to the processing (“opt-in”). In some cases, even if an individual opts-out of disclosures of their personal information, TFS may still disclose such personal information if required to do so by law, if disclosure is required to be made to law enforcement authorities, if we believe disclosure is necessary or appropriate to prevent physical harm or financial loss or in connection with an investigation of suspected or actual illegal activity. TFS also may transfer personal information in the event we sell or transfer all or a portion of our business or assets. Should such a sale or transfer occur, TFS will direct the transferee to use personal information in a manner that is consistent with this Policy.
3.3 Onward Transfers
Transfers to third parties are covered by the provisions in this policy regarding notice and choice. TFS may also share an individual's personal information with agents, contractors or partners of TFS in connection with services that these individuals perform for, or with, TFS. TFS shall ensure that any third party for which personal information may be disclosed subscribes to the principles or are subject to law providing the same level of privacy protection as is required by the principles and agree in writing to provide an adequate level of privacy protection.
3.4 Data Security
TFS will employ reasonable physical, electronic and managerial procedures to safeguard and secure the personal information from loss, misuse, unauthorized access or disclosure, alteration or destruction. TFS cannot guarantee the security of information on or transmitted via the Internet.
3.5 Data Integrity
TFS shall only process personal information in a way that is compatible with and relevant for the purpose for which it was collected or authorized by the individual. To the extent necessary for those purposes, TFS shall take reasonable steps to ensure that personal information is accurate, complete, current and reliable for its intended use.
Upon request, and as required by law, TFS will provide an individual reasonable access to their personal information and allow the individual to correct, amend or delete inaccurate information, except where the burden or expense of providing access would be disproportionate to the risks to the privacy of the individual in the case in question or where the rights of persons other than the individual would be violated.
If a complaint or dispute cannot be resolved through our internal process, we agree to dispute resolution using (EU data Protection Authorities (DPAs) and Swiss Federal data Protection and Information Commissioner (FDPIC)) as a third party resolution provider.
3.9 Information Subject to Other Policies
3.10 Contact Information
Questions, comments or complaints regarding TFS’s Safe Harbor Policy or data collection and processing practices can be sent by email to: email@example.com
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