Maintaining your privacy is important to us and so is being transparent about your information we collect and use. The following policy is intended to help you understand what information we collect, how we use that information, circumstances under which we may share that information, and how we store and secure your information.
When we refer to “OpenClinica,” “we,” or “us” in this policy, we mean OpenClinica, LLC. OpenClinica provides software tools for conducting clinical research studies. We also own and operate a number of websites and offer related services, such as support. We refer to all these products, together with our other services and websites as “Services” in this policy.
Our products are intended for use by our customers which are organizations. Where the Services are made available to you through an organization (e.g. your employer, research sponsor, or data management service provider), that organization is the administrator of the Services and is responsible for the end-users and/or Service sites over which it has control. If this is the case, please direct your data privacy questions to your administrator, as your use of the Services is subject to that organization’s policies. We are not responsible for the privacy or security practices of an administrator’s organization, which may be different than this policy.
We collect the following information about you when you specifically provide it to us, or make use of our Services.
We collect information about you when you input it into the Services or otherwise provide it directly to us.
We collect information about you when you use our Services, including browsing our websites and taking certain actions within the Services.
We also receive information about you form advertising and market research partners who provide us with information about your interest in, and engagement with, our Services and online advertisements.
How we use the information we collect depends in part on which Services you use, how you use them, and any preferences you have communicated to us. Below are the specific purposes for which we use the information we collect about you.
If you have consented to our use of information about you for a specific purpose, you have the right to change your mind at any time, but this will not affect any processing that has already taken place. Where we are using your information because we or a third party (e.g. your employer, the clinical trial sponsor) have a legitimate interest to do so, you have the right to object to that use, though in some cases, this may mean no longer using the Services.
We recognize that your clinical research data is a critical asset and take privacy and security of this data very seriously. We do not share your clinical research data with any third-party unless we are specifically authorized to do so.
Certain other information you provide to us may be shared in the ways described below:
We take the security of your information seriously and have numerous measures in place to protect against the loss, misuse, and alteration of information under our control. While we implement technical and procedural safeguards designed to protect your information, no security system is impenetrable and due to the inherent nature of the Internet, we cannot guarantee that data, during transmission through the Internet or while stored on our systems or otherwise in our care, is absolutely safe from intrusion by others.
We use data hosting service providers in the United States, the European Union, and other locales to host the information we collect. How long we keep information we collect about you depends on the type of information. For example:
You have the right to request a copy of your information, to object to our use of your information (including for marketing purposes), to request the deletion or restriction of your information, or to request your information in a structured, electronic format. Below, we describe the tools and processes for making these requests. You can exercise some of the choices by logging into the Services and using features available from within the Services. Where the Services are administered for you by an administrator (see “Notice to End Users” above), you may need to contact your administrator to assist with your requests first. For all other requests, you may contact us as provided in the Contact Us section below to request assistance.
Your request and choices may be limited in certain cases: for example, if fulfilling your request would reveal information about another person, or if you ask to delete information which we or your administrator are permitted by law or have compelling legitimate interests to keep. Where you have asked us to share data with third parties, you will need to contact those third-party service providers directly to have your information deleted or otherwise restricted. If you have unresolved concerns, you may have the right to complain to a data protection authority in the country where you live, where you work or where you feel your rights were infringed.
Outside of the context of a specific clinical research study being conducted by our customers, for which research subjects have been appropriately consented, our Services are not intended for, or designed to attract, individuals under the age of 16. We do not collect personally identifiable information from any person we actually know is an individual under the age of 16.
Our Services may contain links to third party websites. The policies and procedures described here do not apply to those sites. We suggest contacting those sites directly for information on their privacy, security, data collection, and distribution policies.
To use the OpenClinica Participate and/or the OpenClinica iOS app Services, you should be a participant or potential participant in a clinical study run by one of our customers.
The Services are designed to be used by researchers running studies that obtain your consent and have secured approval from an independent ethics review board, such as your hospital’s Institutional Review Board (IRB). You should ensure you are familiar with the study and consent requirements before using these Services.
Information you provide to us using these Services will be shared with the researchers running the study. OpenClinica will not share, use, or view your data provided under these Services, other than to provide support to the organization running the study.
Under the EU-U.S. and Swiss-U.S. Privacy Shield Frameworks, we are responsible for the processing of information about you we receive from the EU and Switzerland and onward transfers to a third party acting as an agent on our behalf. We comply with the Privacy Shield Principles for such onward transfers and remain liable in accordance with the Privacy Shield Principles if third-party agents that we engage to process such information about you on our behalf do so in a manner inconsistent with the Privacy Shield Principles, unless we prove that we are not responsible for the event giving rise to the damage.
To learn more about the Privacy Shield Program, and to view our certification, please visit our public Privacy Shield listing.
In compliance with the Privacy Shield Principles, OpenClinica, LLC commits to resolve complaints about our collection or use of your personal information. EU and Swiss individuals with inquiries or complaints regarding our Privacy Shield policy should first contact OpenClinica, LLC at firstname.lastname@example.org.
OpenClinica, LLC has further committed to refer unresolved Privacy Shield complaints to JAMS, an alternative dispute resolution provider located in the United States. If you do not receive timely acknowledgment of your complaint from us, or if we have not addressed your complaint to your satisfaction, please visit https://www.jamsadr.com/eu-us-privacy-shield for more information or to file a complaint. The services of JAMS are provided at no cost to you.
You may also contact your local data protection authority within the European Economic Area or Switzerland (as applicable) for unresolved complaints.
Under certain conditions, more fully described on the Privacy Shield website, including when other dispute resolution procedures have been exhausted, you may invoke binding arbitration.
We are subject to the investigatory and enforcement powers of the U.S. Federal Trade Commission (FTC).
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If you have questions or concerns about how your information is handled, please direct your inquiry to:
1075 Main Street, Suite 140
Waltham, MA 02451 USA
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