Theorem Clinical Research, Inc., its successors, subsidiaries, divisions and business units (collectively, "Theorem Clinical Research") is committed to respecting individual privacy and values the confidence of its customers, employees, clinical trial participants, business partners and others. Theorem Clinical Research is aware of the trust placed in it to act in a responsible and law-compliant manner. Theorem Clinical Research is committed to collect, use and disclose personal information in a manner consistent with the laws of the countries in which it does business, including the European Union member countries. This Privacy Policy (the "Policy") sets forth the privacy principles that Theorem Clinical Research follows with respect to transfers of personal information from the European Union (EU) to the United States.
Safe Harbor
The Commission of the European Union and the US Department of Commerce have negotiated and agreed on a set of personal data protection rules (the "Safe Harbor Principles"), allowing U.S. companies to comply with the EU requirement that adequate protection be given for the transfer of personal data out of the EU to the United States. Theorem Clinical Research adheres to the Safe Harbor Principles.
Scope
This Policy applies to all personal information, whether from employees or non-employees such as investigators, received by Theorem Clinical Research in the United States from the EU, in any format, including without limitation electronically. For purposes hereof, "personal information" means any information or set of information that identifies or could be used by or on behalf of Theorem Clinical Research to identify an individual. Personal information does not include information that is encoded or made anonymous, or publicly available information that has not been combined with non-public personal information.
Privacy Principles
The privacy principles in this Policy are based on the Safe Harbor Principles.
Notice:
If Theorem Clinical Research collects personal information directly from individuals in the EU, it will inform them about the purposes for which it collects and uses personal information about them, the types of non-agent third parties to which Theorem Clinical Research discloses that information, and the choices and means, if any, Theorem Clinical Research 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 Theorem Clinical Research, or as soon as practicable thereafter, and in any event before Theorem Clinical Research uses the information for a purpose other than that for which it was originally collected.
If Theorem Clinical Research 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:
Theorem Clinical Research will offer individuals the opportunity to choose (opt-out) whether their personal information can be (a) disclosed to a non-agent third party, or (b) used for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.
For sensitive personal information (i.e. personal information regarding race, ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health or sex life, or personal information treated and identified by a third party as sensitive), Theorem Clinical Research will give individuals the opportunity to affirmatively and explicitly (opt-in) consent to the disclosure of the information to a non-agent third party or the use of the information for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.
Theorem Clinical Research will provide individuals with reasonable mechanisms to exercise their choices.
Data Integrity:
Theorem Clinical Research will use personal information only in ways that are compatible with the purposes for which it was collected or subsequently authorized by the individual. Theorem Clinical Research will take reasonable steps to ensure that personal information is relevant to its intended use, accurate, complete, and current.
Transfers To Agents:
For purposes hereof, "agent" means any third party that uses personal information provided to Theorem Clinical Research to perform tasks on behalf of and under the instructions of Theorem Clinical Research. Theorem Clinical Research will obtain assurances from its agents that they will safeguard personal information consistently with this Policy. Where Theorem Clinical Research has knowledge that an agent is using or disclosing personal information in a manner contrary to this Policy, Theorem Clinical Research will take reasonable steps to prevent or stop the use or disclosure.
Access And Correction:
Upon request, Theorem Clinical Research will grant individuals reasonable access to personal information that it holds about them. In addition, Theorem Clinical Research will take reasonable steps to permit individuals to correct, amend, or delete information that is demonstrated to be inaccurate or incomplete.
Security:
Theorem Clinical Research will take reasonable precautions to protect personal information in its possession from loss, misuse and unauthorized access, disclosure, alteration and destruction.
Enforcement:
Theorem Clinical Research will conduct compliance audits of its relevant privacy practices to verify adherence to this Policy. Any employee that Theorem Clinical Research determines is in violation of this policy will be subject to disciplinary action up to and including termination of employment.
Dispute Resolution:
Any questions or concerns regarding the use or disclosure of personal information should be directed to the Theorem Clinical Research Privacy Office at the address given below. Theorem Clinical Research 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. For complaints that cannot be resolved between Theorem Clinical Research and the complainant, Theorem Clinical Research has agreed to participate in the dispute resolution procedures of the panel established by the European data protection authorities to resolve disputes pursuant to the Safe Harbor Principles.
Contact Information
Questions or comments regarding this Policy should be submitted to the Theorem Clinical Research Privacy Office:
By E-mail:
amy.staedtler@theoremclinical.com
By Mail:
Amy Staedtler, JD
Theorem Clinical Research, Inc
630 Allendale Road
King of Prussia, PA 19406
Telephone: 484-679-2922
Facsimile: 866-852-3685
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 notice will be given concerning such amendments.
Effective Date: June 2002