Embo Registry

Privacy Notice for Clinical Trial Site Personnel

This privacy notice is addressed to :

Clinical Investigators (principal investigators, sub-investigators or co-investigators)
Other site staff such as nurses, medical assistants or research coordinators, whose Personal Data may be processed in the course of the clinical trials and studies sponsored or organized by Vascular Solutions of North Carolina (VSNC).

You are receiving this Privacy Notice because Vascular Solutions of North Carolina (“VSNC”, “we” or “us”) will process information about you, which constitutes “Personal Data.”

This privacy notice is provided to you to ensure transparency in relation to collection, use and disclosure of your Personal Data by VSNC for purposes related to the conduct of clinical trials (collectively “Clinical Studies”) sponsored or organized by VSNC and/or its affiliates which are being carried at you Clinical Trials Site (the “Site”). For the purposes described in this Privacy Notice, VSNC is responsible for the processing of your Personal Data as a “Controller”.

We invite you to read this Privacy Notice carefully, as it contains important information. Should you have any further questions, we invite you to contact emboregistry@vascularsolutions.org.

What Personal Data do we collect and use?

For the purposes described in this Privacy Notice, we may collect the following information about you, including :

name, identification number, address and other contact details,
qualifications, publications and information contained in the CV you provide to us where necessary,
previous experience and other information regarding your participation in Clinical Studies within or outside of VSNC and the training you have received,
technical data related to your use of VSNC's Embo Registry.

Why do we collect and use Personal Data?

Your Personal Data may be used by us for the purposes and on legal bases specified below.

Processing purpose

To conduct VSNC Clinical Studies in accordance with good clinical practice and applicable laws.
To inform you, plan and/or conduct other Clinical Studies including to identify suitable investigators for our studies.
To share information with other companies or industry organizations in the context of planning and conducting Clinical Studies.
To assess the effectiveness of the sites participating in our studies.
To support recruitment of study subjects (for this purpose your name and contact information may be used for study advertisements in print and online media).

Please note that in some countries, consent is the basis on which Personal Data is processed.

Who has access to Personal Data?

We do not share or otherwise transfer personal data to third parties other than those indicated in this Privacy Notice. Personal data may be accessed by or transferred to:

our personnel (including those in our Clinical Trial, Patient Safety, Medical Information, Quality Assurance, and Legal departments) and other VSNC’s companies;
suppliers and services providers acting on behalf of VSNC, that provide services and products to us. These third parties are contractually obliged to protect the confidentiality and security of your Personal Data, in compliance with applicable laws.

Personal data may also be shared with national and/or international regulatory authorities, other enforcement agencies, commissions, courts or ethics committees, including if applicable those based in different jurisdictions, in order to comply with local laws, regulations or pharmaceutical industry codes applicable to VSNC. For that reason, we may disclose information such as the Site’s and/or investigator’s name, Site contact information, name of the Clinical Study, sponsor, copy of the clinical trial agreement, and costs and fees relating to Site’s activities.

Where is Personal Data stored?

Personal data may be processed, accessed, or stored in a country outside the country where you are located, which may not offer the same level of protection of personal data. If we transfer your Personal Data to other jurisdictions, we will make sure to protect your Personal Data by (i) applying the level of protection required under the local data protection/privacy laws applicable in the country of destination, (ii) acting in accordance with our policies and standards and, unless otherwise specified or required, by transferring your Personal Data on the basis of standard contractual clauses approved by the FDA. You may request additional information in relation to international transfers of Personal Data and obtain a copy of the adequate safeguard put in place by exercising your rights as described below.

How long do we store Personal Data?

We will keep your Personal Data as long as needed for legal and regulatory requirements.

What are your rights and how can you exercise them?

You have the right to:

access your personal data and, if you believe that it is incorrect, obsolete or incomplete, to request that it is corrected or updated;
request the erasure of your personal data or the restriction of its use;
if the processing is based on your consent, to withdraw your consent at any time, without affecting the lawfulness of the processing before such withdrawal;
object, in whole or in part, to the processing of your personal data; and
request portability of your personal data (i.e. for it to be returned to you or transferred to the person of your choice, in a structured, commonly used and machine-readable format).

We may apply exceptions to these rights where appropriate and in accordance with local law. In any case, you also have the right to file a complaint with a supervisory authority in addition to your rights above.

This Privacy Notice was last updated in April 2024 changes or additions will be notified through our usual communication channels (e.g. via our website).