RCRI

Notice

RCRI acts solely as an agent of the Sponsor. In this capacity, RCRI may be assigned the responsibility to collect Personal Information directly from study subjects, study investigators, or other sources in the E.U. or may receive such Personal Information directly from the Sponsor. The latter holds legal authority for conduct of the clinical research. RCRI is contractually forbidden from independently releasing the Personal Information to third parties or using the Personal Information in a manner outside the scope of documented work instructions, or as required by law.The provision of study subjects’ rights for “Notice” as stated in the Principles is under the control of the Sponsor and is implemented via an informed consent process which describes the purposes for which the data are collected and used and to what third parties their data are provided as well as how to contact the Sponsor or RCRI in the event of inquires or complaints. Should RCRI determine that fulfillment of its responsibilities will require that a study subject’s right of “Notice” be expanded beyond that provided in the Sponsor’s original informed consent process, RCRI will notify the Sponsor and assist the latter in the provision of “Notice” prior to initiating the requested work activities.

Choice

When RCRI is contractually requested to provide guidance to the Sponsor regarding the informed consent process for study subjects in the E.U. or Switzerland, RCRI will recommend incorporation of the provisions pertaining to “Choice”. The Sponsor alone holds the legal authority to provide study subjects the choice to (opt out) 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. Similarly for Sensitive Personal Information, RCRI is under the legal authority of the Sponsor to give individuals the opportunity to affirmatively or explicitly choose (opt in) to allow the disclosure of their Sensitive Personal Information for a purpose other than the purpose for which it was originally collected or to be disclosed to a third party.

Onward Transfer

RCRI may share Personal Information with its subcontractors or other agents of the Sponsor as necessary to successfully fulfill the work instructions provided by the Sponsor. RCRI may, for example, provide such Personal Information to subcontractors hosting our databases, to core laboratories participating in the research project, or to study subjects that request copies of the Personal Information collected by the Sponsor. In the latter two examples, the authority for “onward transfers” is held by the study Sponsor.

RCRI will obtain assurances from its subcontractors that they will safeguard Personal Information consistently with this Safe Harbor Policy. Examples of appropriate assurances that may be provided by subcontractors include: a contract with provisions obligating the subcontractor to provide at least the same level of protection as is required by the relevant Safe Harbor Principles, being subject to the EU or Switzerland Data Protection Directive, Safe Harbor certification by the subcontractor, having Binding Corporate Rules approved by the European Commission, or being subject to another European Commission adequacy finding (e.g., Argentina, Canada, Buernsey, or Isle of Mann).

Where RCRI has knowledge that a subcontractor is using or disclosing Personal Information in a manner contrary to this Safe Harbor Policy, it will take reasonable steps to prevent or stop the use or disclosure.

Access

RCRI is contractually prohibited from releasing or otherwise disclosing Personal Information received from or on behalf of the Sponsor without written permission from the Sponsor, or as required by law . All requests for “Access” will be forwarded to the Sponsor for processing and RCRI will abide by any resulting instructions to correct, amend or delete Personal Information about themselves.

Data Security

RCRI shall take reasonable steps to protect the Personal Information in its possession from loss, misuse, unauthorized access, unapproved disclosure, erroneous alteration, and unintended destruction. RCRI has implemented appropriate physical, electronic, and quality system procedures to safeguard and secure Personal Information. RCRI cannot guarantee the security or accuracy of Personal Information recorded, transcribed, or processed prior to its receipt or subsequent to its surrender to the Sponsor. RCRI is not responsible for the illegal acts of third parties or the consequences of such acts.

Data Integrity

RCRI is contractually bound to process Personal Information only in a manner that is consistent with the responsibilities assigned to it by the Sponsor. To the extent necessary and appropriate for those purposes, RCRI shall take reasonable steps to ensure that Personal Information is accurate, complete, current and reliable for its intended use.

Enforcement

RCRI uses a self-assessment approach to assure compliance with this Safe Harbor Policy and periodically verifies that the Safe Harbor Policy is accurate, comprehensive for the information intended to be covered, prominently displayed, completely implemented and accessible and in conformity with the Principles. Any employee of RCRI found to have acted in violation of this Safe Harbor Policy will be subject to disciplinary action up to and including termination of employment.

In compliance with the US-EU and US-Swiss Safe Harbor Principles, RCRI commits to resolve complaints about your privacy and our collection or use of your personal information. European Union or Swiss citizens with inquiries or complaints regarding this privacy policy should first contact RCRI at:

RCRI has further committed to refer unresolved privacy complaints under the US-EU and US-Swiss Safe Harbor Principles to an independent dispute resolution mechanism, the BBB EU SAFE HARBOR, 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 by RCRI, please visit the BBB EU SAFE HARBOR web site at www.bbb.org/us/safe-harbor-complaints for more information and to file a complaint.