This study is currently being conducted in the US and is for US residents only.
CAUTION: Investigational product. Limited by FDA regulations to investigational use only.
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SUI US Clinical Research Study Pre-Screening Privacy Policy

Privacy and Security Policy

Clinical trials are the cornerstone for validating the efficacy and safety of investigational drugs, therapies and devices prior to market availability. The process for obtaining the required regulatory approval to bring products to market is extremely rigorous. As part of evaluating interested patients for study enrollment, individuals are requested to provide and entrust a Clinical Research Study Pre-Screening Agency(ThreeWire, Inc., or “Pre-Screening Agency”) with confidential and personal information (“Personal Information”). The following privacy and security policy (“Policy”) has been adopted to ensure participants that their Personal Information will be protected by fair trade practices and in accordance with all applicable laws, including the applicable data privacy laws  as well as the requirements under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

The Pre-Screening Agency is committed to protecting your Personal Information. They use computer systems to store your information using best-practice standards to keep your information from being seen by anyone that should not see it. This Policy explains what information they may gather, and for what purpose. You may contact them with questions about this Policy or to place restrictions on the use of your Personal Information outside of the scope of this Policy.

As used in this Policy, “you”, “your”, or “participant” refers to an individual who has elected to provide Personal Information to the Pre-Screening Agency as part of the individual’s participation in the SUIClinical Research Study recruitment effort. This Policy covers our website at www.ResearchSUI.com.

Our Commitment:

The Pre-Screening Agency is committed to the following on your behalf:

  1.  We will not disclose, share or distribute your Personal Information to any third party without your prior express permission.
  2. We will strictly adhere to the requirements of HIPAA regulations as set forth by the U.S. federal government.
  3. We will maintain the integrity of your Personal Information in a private and secure system requiring strict permissions and layered access.
  4. Participant names and Personal Information may be disclosed to third parties if required in connection with a legal proceeding such as a court order or, subpoena. In such cases we will attempt to inform you prior to disclosure so that you may exercise any legal rights you may have to prevent it.
  5. We will collect, affirm and honor your communication preferences whenever a preference capability is offered.
  6. All participants will be provided with the reasonable ability to access and update their Personal Information, as appropriate by calling 1-952-852-5656 or by providing your request in writing to: Privacy Officer, 7706 Golden Triangle Drive, Eden Prairie, MN 55344.
  7. We will only use your Personal Information for identifying you within a given clinical trial for which you may be eligible, in all cases only with your consent and within the confines of regulatory and industry standards.

Personal Information

This Policy applies only to “Personal Information”, which is any information that can be used to identify you. Under HIPAA, some types of this information may be referred to as Personal Health Information, or PHI, which may be information describing your health, including symptoms, diagnoses, testing or test results, and medical care services and procedures including medications. It may also include information that could be used to identify you if used in conjunction with other types of information. Our Policy does not apply to situations where we may gather information from third party sources that do not identify you specifically.

Generally, we obtain Personal Information about you by virtue of you providing us with such information. The only Personal Information about you that we collect from third parties is information that you provide in an opt-in fashion. For example, we do not have access to your medical records except in cases where we are providing services to or through a medical professional from whom you have obtained services and with whom we have an appropriate data privacy agreement in place.

We may ask you for Personal Information in various locations on our website, via telephone or other means. In some situations you will be required to provide Personal Information because of the activity that you are performing. For example, we will need your real name to enroll you in a clinical trial. In other cases, the information you are being asked to provide is optional. We designate which information is optional throughout our website and other study processes.

The information we seek to collect via electronic mail, web outreach, our call center and/or physician practice services allows us to provide you (whether you are a participant, physician, or authorized caregiver) with information that is targeted specifically to you or the individual for whom you are seeking information.

What Types Of Data Do We Collect?

The information we collect is useful in identifying when, where and how you may be eligible for clinical trials or other healthcare related benefits. We may seek Personal Information on our website or through other electronic means, through our call center, or by mail, within process of a clinical trial.

Typical data collection involves only information you provide and may include:

  • Your name, email address, address and phone number.
  • Demographic information such as birth date and gender.
  • Additional information about yourself so that we can provide you with further information and follow-up.
  • Information we or a clinical trial sponsor need to know to learn whether you satisfy the inclusion/exclusion requirements for a particular trial. Typically, we create a brief questionnaire served as a web-form on our websites and/or generated through our call center. This is likely to ask for basic medical information as well as information relevant to your candidacy for a given trial. If you meet the prequalification criteria for the trial, and grant us express permission to do so, your information will be forwarded to an investigator in your area for further evaluation.
  • Information we obtain from third parties to whom you have given your Personal Information and the consent to use it for authorized purposes.

What are your rights over your health information?

You have the right to:

  • See and obtain a copy of your health information. To see or obtain a copy of your health information, write or request this information from us at the address provided herein.   You may have to pay for the cost of copying and mailing your records.
  • Ask for changes to your health information. If you feel that your health information is incorrect or incomplete, you can ask us to change it.
  • Know how your health information is shared with others. We use your health information to screen, enroll and process your participation in clinical trials.

Database Practices

We do not sell, share, rent or trade your Personal Information with third parties other than as disclosed within this Policy or with your express written consent.

Data Systems Security

We employ technology and procedures to protect the security of your Personal Information during its collection, transmission, storage and use:

  • FIREWALLS: We protect our servers from unauthorized access by using multiple firewalls. Firewalls are controlled barriers that prevent network traffic from flowing between computers without specific permission. Data maintained on our servers, including all Personal Information and Personal Health Information, are on servers which are themselves only accessible from our proprietary software running on other servers on our network. All activity among our network servers is logged and reviewed periodically. All study staff require passwords to access these servers and all internal activity is logged and reviewed on a periodic basis.
  • DATA ENCRYPTION: All Personal Information or Personal Health Information collected by us is encrypted during transmission between our servers as well as the computer from which you are accessing our web sites. We use Secure Socket Layer (SSL). SSL is an industry-standard encryption format supported by all web browsers. In most browsers, including Internet Explorer, Safari, Chrome, and Firefox, you can verify that you are viewing an encrypted and secure page by looking for a lock icon in the “location bar” or “address bar” (the area in which you typed or can see the URL of the website). The presence of an icon of closed padlock in either the left or right of the location bar (depending on your web browser) indicates the page is secure and encrypted. An unencrypted page would either display no lock icon, or the image of an open lock, depending on your browser.
  • RESTRICTED ACCESS: In addition to the various techniques we use to protect your Personal Information online, we take additional measures to protect this Personal Information offline. We restrict access to all information we receive or maintain, including your Personal Information. Only those employees who require access to the information to perform a specific job function (such as certain members of our information technology staff) are granted access to your Personal Information, and such access is both password-controlled and logged. All of our employees are educated on our security and privacy policies, as well as being required to review these policies on a regular and periodic basis, as well as any time the policies change.
  •  PHYSICAL SECURITY: The physical environment in which we store personal data is also protected and secured. Servers which store Personal Information are maintained in a secure environment, within locked, access-restricted and climate controlled rooms.

Alliance Business Relationships

We frequently provide our services by working in tandem with other businesses that we refer to as our business partners. We do not provide your Personal Information to any of our business partners without your prior permission, nor do we ever receive records or personal data from a doctor, trial investigator or any other third party without your prior permission. Our business partners have their own privacy policies, and in cases where you have given us consent to share your information with them, you should review their privacy policies, which are typically located on their websites.

Standard Operating Procedures (SOPs)

When you register with us you are indicating your consent to permit us to maintain your name in our database and communicate relevant information you have identified as valuable. We may periodically contact you using the information you have provided. If you expressly request us to keep you informed about a trial in which you have enrolled, we will do so. If you agree, we may periodically contact you using the information you have provided in order to facilitate your participation in a trial. You may opt-out of select communications mediums at will on an individual instance basis.

At any time, you may indicate to us that you wish to stop receiving communications from us. You can achieve this by contacting us by phone at 1-952-852-5656, through our websites or by providing your request in writing to: Privacy Officer, 7706Golden Triangle Drive, Eden Prairie, MN 55344.

Once You Become Part of a Clinical Trial

Since we may have been your first point of contact related to a trial, we may be tasked with keeping you informed regarding the trial process even after you are enrolled. Depending on the clinical trial Investigator, and with your consent using only information you provide to us, we may be charged with providing communications related to the study.

Questions, Concerns, Complaints

If you have questions or concerns regarding this policy you may contact us directly by phone at 1-952-852-5656 or by writing to:Privacy Officer, 7706 Golden Triangle Drive, Eden Prairie, MN 55344. Please address your correspondence to our Privacy Officer and include the following information: your specific question related to this policy, perceived breach or other concern; your contact information; and whether you would like us to contact you regarding your complaint.

By providing your Personal Information to us, you agree to be bound by all of the terms of this Privacy Policy as contained herein or as amended. Further, you agree that all dispute resolutions shall be conducted in English and any and all legal proceedings resulting therefrom shall be conducted in accordance with the laws of the United States and the State of Minnesota, as applicable, and only in State or U.S. Federal Courts located in Minnesota, USA.