effective as of January 1, 2009
Novella Clinical is committed to complying with relevant laws and respecting high standards in handling our own and our clients' data. We recognize the importance of protecting personal data and individual privacy, and our standards comply with such internationally recognized programs as the US Health Insurance Portability and Accountability Act (HIPAA), the European Union’s Data Protection Directive (EUDP, EC/95/46), and the U.S. Department of Commerce Safe Harbor Agreement.
Novella Clinical’s Chief Privacy Officer monitors our company’s compliance with all applicable privacy laws and regulations, and with our corporate data protection standards. Our Chief Privacy Officer is also responsible for handling any questions or complaints that Novella Clinical may receive regarding data privacy, as well as handling requests for access to personal information that Novella Clinical holds.
All Novella Clinical employees are trained on our privacy standards and taught to comply with all applicable laws and regulations on data privacy.
Novella Clinical is compliant with the Safe Harbor frameworks established by the US Department of Commerce in consultation with the European Commission and the Federal Data Protection and Information Commissioner of Switzerland, and adheres to its seven principles in connection with the transfer of all personal information from the European Union and Switzerland to the United States. Personal information includes any information that identifies or could be used by or on behalf of Novella Clinical to identify an individual. Personal information does not include information that is encoded or anonymized or publicly available information that has not been combined with non-public personal information.
Notice: Novella Clinical collects information for the purposes of clinical research and statistical analysis. Novella Clinical and its affiliates, subsidiaries and agents use customary measures in the clinical trial industry to recruit and inform study participants about the respective clinical trial research. Investigators and their requisite Institutions selected to conduct clinical trials may also provide additional information in accordance with industry standards. The informed consent notices the study participant of the research rationale, the types of collected data, and the manner in which the data will be used. Clinical research information is collected in a manner that does not contain any individual identifiers in accordance with industry standards. However, in the event that Novella Clinical does collect personal information, then at the time the information is taken, Novella Clinical informs the individuals in clear and conspicuous language of the purpose and use of the information. Depending on the type of data processing, notice may be given in person, by e-mail, mail, telephone or by posting on our Web site. Novella Clinical will also provide individuals with corporate contact information and their choices and means Novella Clinical offers for limiting the use and disclosure of their personal information. When Novella Clinical receives personal information from our subsidiaries, affiliates or other entities, we 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: Novella Clinical gives individuals the opportunity to choose (opt out) whether their personal information will be disclosed to a third party, or used for a purpose other than which it was originally intended. For sensitive information (i.e. personal information specifying medical or health conditions, racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership or information specifying the sexual orientation of the individual), affirmative or explicit (opt in) choice is given to the individual if the information is to be disclosed to a third party or used for a purpose other than its original purpose or the purpose authorized subsequently by the individual.
For those individuals participating in clinical trials who have previously given informed consent for participation and use of personal information in the trial, such information may be used if this restriction has been explained when the participant entered the trial and the disclosure of such information would jeopardize the integrity of the research effort. Agreement to participate in the trial under these conditions is a reasonable forgoing of the right of access. Following the conclusion of the trial and analysis of the results, participants should have access to their data if they request it. They should seek it primarily from the physician or other health care provider from whom they received treatment within the clinical trial, or secondarily from the sponsoring company.
Onward Transfer (Transfers to Third Parties): If Novella Clinical will disclose the personal information to a third party, such as a partner, consultant or subcontractor that we are working with on a project, we will make sure that the third party also subscribes to the safe harbor principles or is subject to the Directive or another adequacy finding; or in the alternative, we will enter into a written agreement with the third party requiring that the third party be held to the same level of privacy protection as required by the relevant principles.
Access: Upon written request, Novella Clinical will provide individuals with their personal information that we hold, so that it may be corrected, amended, or deleted where the information was inaccurate, unless by doing so the rights of persons other than the individual would be violated. Novella Clinical, its subsidiaries, affiliates and authorized agents collect information for the purposes of clinical research and statistical analysis. Clinical research information is collected in a manner that does not contain any individual identifiers in accordance with industry standards. Without any individual identifiers, unauthorized third parties should not have the capability to access the information. If an individual study participant desires access, it can be requested through the investigator or physician from whom the participant received treatment in accordance with customary practices and regulations in the pharmaceutical industry.
Security: Novella Clinical will take reasonable precautions to protect personal information from destruction, loss, alteration, or unauthorized disclosure or access.
Data Integrity: Personal Information that Novella Clinical acquires in the course of our business, is limited to only what is relevant and necessary for the intended purpose. We take all reasonable steps to ensure that the information is accurate, complete, current, and reliable for its intended use.
Contact Information: Any questions or concerns regarding personal information should be directed to Novella Clinical’s Chief Privacy Officer at the following address:
Attention: Chief Privacy Officer
1700 Perimeter Park Drive
Morrisville, NC 27560
Novella Clinical 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. Novella Clinical 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 Novella Clinical’s certification, please visit http://www.export.gov/safeharbor/.
RESERVATION OF RIGHTS: Novella Clinical reserves the right to share an individual's information as required by law or to duly authorized requests for information made by government authorities.
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