Legal
This Clinical Trial Site Staff Privacy Notice explains how Retension Pharmaceuticals, Inc. (“Retension” or “Sponsor”) collects, uses, discloses, transfers, and protects personal data relating to investigators, study coordinators, and other clinical trial site personnel involved in Retension-sponsored clinical trials (the “Study” or “Studies”). Clinical trials may be managed on Retension’s behalf by a designated contract research organization (“CRO”) and other service providers.
This Notice is intended to apply across the regions in which Retension-sponsored Studies are conducted, subject to applicable local law. Retension is committed to handling personal data transparently and in accordance with applicable privacy, data-protection, clinical-research, and regulatory requirements.
This Notice is directed to clinical trial site staff. It is not a participant informed-consent or participant privacy notice.
Personal data is information that identifies you directly or indirectly. This may include your name, contact information, professional credentials, identification information, financial information, or online and authentication identifiers.
In connection with a Retension-sponsored Study, Retension, its designated CRO, or other authorized service providers may collect personal data relating to site personnel, including:
Certain information may be necessary for Retension and its service providers to administer the Study and satisfy clinical, contractual, legal, or regulatory requirements. If required information is not provided, participation in Study-related activities may not be possible.
Retension may process site-staff personal data for the following purposes. The lawful basis relied upon may vary by jurisdiction and will apply only where recognized under applicable law.
Purpose: To administer Retension-sponsored clinical trials and protocols, including site selection and management, performance of clinical trial agreements, Study-related payments, monitoring, auditing, training, system access, and maintenance of the trial master file (“TMF”).
Lawful Basis: Where applicable, processing may be necessary for Retension’s legitimate interests in administering and overseeing clinical research, performance of contractual obligations, and/or other lawful bases available under applicable law.
Purpose: To conduct and support biomedical research and development, evaluate the therapeutic suitability and development of investigational products, analyze Study operations, and support applications for product registration.
Lawful Basis: Where applicable, processing may be necessary for Retension’s legitimate interests in conducting scientific research and developing pharmaceutical products and/or another lawful basis recognized under applicable law.
Purpose: To comply with legal, regulatory, safety, quality, inspection, recordkeeping, and clinical-trial obligations, including obligations associated with applications for product registration.
Lawful Basis: Processing may be necessary to comply with applicable legal or regulatory obligations.
To support the purposes described above, Retension may disclose site-staff personal data, as appropriate, to:
Certain information concerning clinical trials may also be submitted to public clinical-trial registries, such as ClinicalTrials.gov, as required by applicable law or regulation. Retension does not intend through this Notice to suggest that all categories of site-staff personal data described above are published in such registries.
Personal data may also be disclosed in connection with an actual or proposed corporate transaction, such as a merger, financing, acquisition, reorganization, divestiture, sale of assets, bankruptcy, or dissolution, subject to applicable legal requirements and appropriate protections.
Clinical research may involve organizations and systems located in multiple countries. As a result, personal data may be transferred to or processed in countries outside the country in which you work or reside. Where the EU GDPR or UK GDPR applies, Retension Pharmaceuticals, Inc. is the controller of the site-staff personal data described in this Notice, unless otherwise stated.
Those countries may have privacy and data-protection laws that differ from those in your jurisdiction. Where required by applicable law, Retension will use appropriate safeguards for international transfers, which may include an applicable adequacy mechanism, approved contractual safeguards, or another legally recognized transfer mechanism.
For additional information regarding safeguards applicable to international transfers, including how to request information about or, where available, obtain a copy of applicable safeguards, contact Retension at privacy@retensionpharmaceuticals.com.
Retension retains personal data for as long as reasonably necessary to fulfill the purposes for which it was collected and to satisfy applicable clinical-trial, scientific, contractual, legal, regulatory, accounting, and recordkeeping requirements.
Clinical-trial records may be subject to specific regulatory retention requirements. In determining appropriate retention periods, Retension may consider the nature and sensitivity of the information, the purposes of processing, legal and regulatory obligations, and the risks associated with unauthorized use or disclosure.
Retension uses administrative, technical, and organizational safeguards designed to protect personal data against unauthorized access, loss, misuse, alteration, or disclosure.
No system or method of electronic transmission or storage can be guaranteed to be completely secure. If a personal-data breach occurs, Retension will take appropriate steps and provide notifications where required by applicable data-protection or other applicable law.
Depending on where you reside or work and subject to applicable law, you may have rights concerning your personal data. These may include the right to:
These rights may be limited by applicable clinical-trial, scientific, legal, or regulatory requirements, including obligations requiring Retension to maintain certain Study records.
To exercise or inquire about applicable privacy rights, contact privacy@retensionpharmaceuticals.com.
If you have questions, concerns, or complaints regarding this Notice or Retension’s handling of site-staff personal data, please contact:
Retension Pharmaceuticals, Inc.
Email: privacy@retensionpharmaceuticals.com
This Notice applies to personal data processed in connection with your role as an investigator, study coordinator, or other clinical trial site professional.
For information regarding Retension’s public website, including website-related personal information and cookies, please review our Website Privacy Policy and Cookie Policy, as applicable.
Retension may update this Notice periodically to reflect changes in its clinical-trial practices, service providers, legal or regulatory requirements, or privacy practices. When appropriate, Retension will make the updated Notice available and identify the applicable effective or revision date.