Safe Harbor Privacy Statement
INTRODUCTION:
Prologue Research International, Inc. (“Prologue”) adheres to the Safe Harbor Agreement concerning the transfer of personal data from the European Union (“EU”) to the United States of America. Accordingly, Prologue follows the Safe Harbor Principles published by the U.S. Department of Commerce (the “Principles”) with respect to all such data. If there is any conflict between the policies in this privacy policy and the Principles, the Principles shall govern. This privacy policy outlines Prologue’s general policy and practices for implementing the Principles, including the types of information gathered, how it is used, and the notice and choice affected individuals have regarding use of and ability to correct that information. This privacy policy applies to all personal information received by Prologue whether in electronic, paper or verbal format.
SCOPE:
This policy applies to all personal information, either in electronic or paper format, received by Prologue Research International, Inc. (Prologue) from member states of the European Union.
DEFINITIONS:
For the purposes of this policy, the following definitions shall apply:
“Agent”: means any third party that uses personal information provided to it by Prologue to perform tasks on behalf of Prologue.
“Data Controller”: means the natural or legal person, public authority, agency or any other body which alone or jointly with others, determines the purposes and means of the processing of personal information.
“Data Subject”: means any participant or applicant wishing to participate in a clinical trial together with any next of kin, if appropriate, and/or any other person about whom data is collected, including Trial Data.
“Personal Information”: means any information, including Trial Data that identifies or could be used by or on behalf of Prologue to identify any individual. Personal information does not include information that is coded, anonymized, or publicly available.
“Privacy”: means the freedom from unauthorized intrusion; the right of a person to control who has access to information about him or her.
“Processing of Personal Information”: means any operation or set of operations which is performed upon personal information, whether or not by automatic means, such as collection, recording, organization, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, blocking, erasure or destruction.
“Prologue”: means Prologue Research International, Inc., including its subsidiaries, and affiliates, divisions, and groups in the United States.
“Sensitive Personal Information”: means personal information, including Trial Data, that pertains to racial or ethnic groups, political or religious beliefs, health or sex life, membership to trade-unions, social welfare, criminal charges or convictions as well as membership to societies related to any of these characteristics.
“Sponsor”: means the company, individual or entity that supports a clinical trial for which Prologue provides services or assistance.
“Trial”: means any Sponsor-supported clinical trial for which Prologue provides services or assistance.
“Trial Data”: means all data relating to any Data Subject collected by or transferred to Prologue, its affiliates or business partners in connection with services provided to a trial Sponsor.
PRIVACY PRINCIPLES:
The privacy principles in this policy are based on the Safe Harbor Principles as established by the United States Department of Commerce.
NOTICE:
Where Prologue collects personal information from individuals, including Trial Data, it will inform them about the:
- Purposes for which it collects and uses the personal information about them;
- Types of non-agent third parties to which Prologue discloses that information;
- Choices and means, if any, that Prologue offers individuals for limiting the use and disclosure of their personal information.
Such notice will be provided in clear and conspicuous language when the individuals are first asked to provide personal information, or as soon as practicable, but in any event before Prologue uses the information for a purpose other than the purpose for which it was originally collected or subsequently authorized by the individual.
CHOICE:
Prologue will offer individuals the opportunity to refuse (opt-out) to allow their personal information (a) to be disclosed to a non-Agent 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, Prologue will give individuals the opportunity to affirmatively and explicitly agree (opt-in) (a) to the disclosure of the information to a non-Agent third party or (b) to use the information for purposes other than those for which it was originally collected or subsequently authorized by the individuals.
Prologue will provide individuals with reasonable mechanisms to exercise their choices.
DATA INTEGRITY:
Prologue will use personal information only in ways that are compatible with the purposes for which it was originally collected or subsequently authorized by the individuals. Prologue will take reasonable steps to ensure that personal information is relevant to its intended use, accurate, complete and current.
TRANSFER TO AGENTS:
Subject to the prior approval of the relevant Sponsor, Prologue may share an individual’s personal information with Agents, which may include individuals or entities performing work on behalf of Prologue. For example, Prologue may provide an individual’s personal information to its Agent for database processing or for hosting a database. Prologue will obtain assurances from its Agents that they will safeguard personal information in a manner consistent with this Policy. Examples of assurances that may be provided by Agents include: a contract with provisions obligating the Agent to provide the same level of protection as required in this Policy or confirmation of Safe Harbor Certification by the Agent. Where Prologue has knowledge that an Agent is using or disclosing personal information in a way contrary to this Policy, Prologue will take reasonable steps to prevent or stop that use or disclosure.
ACCESS AND CORRECTION:
Upon request, Prologue will grant individuals reasonable access to personal information that it holds about them. In addition, Prologue will take reasonable steps to permit individuals to correct, amend, or delete information that is found to be inadequate or incomplete. However, due to regulatory requirements, and to ensure the scientific integrity of the clinical trials on which it works, Prologue may not be able to provide direct access to research data to research participants or clinical investigators.
SECURITY:
Prologue will take reasonable precautions to protect personal information in its possession from loss, misuse, unauthorized access, disclosure, alteration and destruction. Prologue has put in place appropriate physical, electronic and managerial procedures to safeguard and secure the Information from loss, misuse, unauthorized access or disclosure, alteration or destruction. Prologue cannot guarantee the security of Information on or transmitted via the Internet.
ENFORCEMENT:
Prologue will conduct compliance audits of its relevant privacy practices to verify adherence to this policy. Any employee that Prologue 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 Chief Privacy Officer at the address provided below. Prologue will investigate and attempt to resolve complaints regarding the use and disclosure of personal information in accordance with the principles contained in this Policy.
If a complaint or dispute cannot be resolved through Prologue’s internal process, Prologue agrees to use the European Data Protection Authorities (DPAs) as a third party dispute resolution provider.
CONTACT INFORMATION:
Questions, comments or complaints regarding Prologue’s Safe Harbor Policy should be submitted to Prologue’s Corporate Office by mail at the following address:
Chief Privacy Officer
Prologue Research International, Inc.
580 North 4th Street, Suite 270
Columbus, OH 43215
CHANGES TO THIS POLICY:
This Policy may be amended from time to time to remain consistent with the requirements of the Safe Harbor. Any revisions to this policy will be posted on Prologue’s website.
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