Data Protection at PRA International
PRA respects individual privacy and values the confidence of its customers, employees, clinical trial participants, healthcare professionals, consumers, business partners, investors, and others. Not only does PRA strive to collect, use, and disclose personal information in a manner consistent with the laws of the countries in which it does business, but it also has a tradition of upholding the highest ethical standards in its business practices. For these reasons, PRA has developed a comprehensive, global privacy program designed to respect and protect the data privacy rights of every person with whom we transact business.
PRA intends that its corporate privacy policy and standard practices and procedures will ensure timely compliance with applicable local and international laws and regulations.
This Safe Harbor Privacy Policy (the "Policy") sets forth the privacy principles that PRA follows with respect to transfers of personal information from the member states of the European Union (EU) to the United States (US).
This Policy applies to all personal information received by PRA in the US from a member state of the EU in any format including electronic, paper, or verbal. This policy sets certain minimum standards within PRA which may be subjected to more stringent privacy safeguards as a result of the requirements of GCP, ICH, or other national and international requirements.
For purposes of this Policy, the following definitions shall apply:
"Agent" means any third party that uses personal information provided by PRA to perform tasks on behalf of and under the instructions of PRA.
"PRA" means PRA International, its predecessors, successors, subsidiaries, divisions and groups in the United States.
"Personal information" means any information or set of information that identifies or could be used by or on behalf of PRA to identify an individual. Personal information does not include information that is encoded or stripped of all personal identifiable information, or which is publicly available.
"Sensitive personal information" means personal information that reveals race, ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, or that concerns the health or sex life of an individual. In addition, PRA will treat as sensitive personal information any information received from a third party where that third party treats and identifies the information as sensitive.
The privacy principles in this Policy are based on the Safe Harbor Privacy Principles.
NOTICE: Where PRA collects personal information directly from individuals in the EU, it will inform them about the purposes for which it collects and uses the information, the types of third parties to which PRA discloses that information, and the choices and means, if any, PRA offers individuals 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 PRA, or as soon as practicable thereafter, and in any event before PRA uses the information for a purpose other than that for which it was originally collected.
Where PRA receives personal information from its subsidiaries, affiliates or other entities in the EU, 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.
CHOICE: PRA will offer individuals the opportunity to choose (opt-out) whether their personal information is (a) to be disclosed to a third party, or (b) to be used for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.
For sensitive personal information, PRA will give individuals the opportunity to affirmatively and explicitly (opt-in) consent to the disclosure of the information to a third party or to the use of the information for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.
PRA will provide individuals with reasonable mechanisms to exercise their choices.
DATA INTEGRITY: PRA will use personal information only in ways that are compatible with the purposes for which it was collected or subsequently authorized by the individual. PRA will take reasonable steps to ensure that personal information is relevant to its intended use, accurate, complete, and current.
TRANSFERS TO AGENTS: PRA may share an individual's information with agents, contractors or partners of PRA in connection with services that these individuals or entities perform for, or with, PRA. PRA may, for example, provide an individual's personal information to contractors or business partners for hosting our databases, for data processing services, or to send to that individual the information that he or she requested.
PRA will obtain assurances from its agents and contractors that they will safeguard personal information received from us in a manner consistent with this Policy. Appropriate assurance of compliance may be given in a number of ways, which may include one or more of the following:
A contract between PRA and the third party which includes provisions obligating the third party to provide at least the same level of protection as is required by the relevant Safe Harbor Principles.
The third party may be, subject to the EU Data Protection Directive itself.
The third party may have filed its own Safe Harbor certification.
Commission adequacy finding (e.g. Argentina, Canada, Guernsey, Hungary, Isle of Mann, Switzerland).
Where PRA has knowledge that an agent, contractor or partner is using or disclosing personal information in a manner contrary to this Policy, PRA will take reasonable steps to prevent or stop the use or disclosure.
ACCESS AND CORRECTION: Upon request, individuals will be granted reasonable access to personal information that PRA holds about them. In addition, upon request, PRA will take reasonable steps to permit individuals to correct, amend, or delete information that is found to be inaccurate or incomplete.
SECURITY: PRA will employ reasonable safeguards to protect personal information in its possession from loss, misuse and unauthorized access, disclosure, alteration and destruction. For personal information subject to electronic storage or transmission, PRA maintains an internal private, secure global network that is protected from computer virus infection and monitored for unauthorized access. Both electronic and paper based records holding personal information are maintained in access controlled facilities for which business continuity plans are required.
ENFORCEMENT: PRA will conduct compliance audits of its relevant privacy practices to verify adherence to this Policy.
All reported breaches or potential breaches will be investigated by the Privacy Officer(s) and the investigative agents the Officer assigns, who will take such actions as they deem appropriate in the investigation and if necessary, remediation of the situation. Any employee that PRA determines is in violation of this Policy will be subject to disciplinary action up to and including termination of employment. In the event of criminal or other serious violations of the law, these actions could also be subject to notification of the appropriate legal body.
DISPUTE RESOLUTION: Any questions or concerns regarding the use or disclosure of personal information should be directed to the Privacy Officer at the address given below. PRA will investigate and attempt to resolve complaints and disputes regarding use and disclosure of personal information in accordance with the principles contained in this Policy.
CONTACT INFORMATION: Questions or comments regarding this Policy should be submitted to the PRA Privacy Office by mail to:
Pharmaceutical Research Associates, Inc.
C/o Privacy Officer
4105 Lewis and Clark Drive
Charlottesville, VA 22911
PrivacyOfficer@praintl.com
Or contact the Privacy Officer by submitting your questions or comments here .
If you feel that PRA may not have abided by the US – EU Safe Harbor privacy principles, you may contact PRA at the address above, or the US Federal Trade Commission.
RESERVATION OF RIGHTS: PRA reserves the right to share an individual's information as required by law or to duly authorized information requests of government authorities.
CHANGES TO THIS SAFE HARBOR PRIVACY POLICY: This Policy may be amended from time to time, consistent with the requirements of the Safe Harbor Principles. Appropriate public notice will be given concerning such amendments.