This website https://www.evrysdipregnancyregistry.com, including any and all platforms built with the intended purpose to use either in conjunction with, in addition to, or in lieu of this website (hereinafter collectively referred to as “Website”) is owned by IQVIA and managed on behalf of F. Hoffmann-La Roche Ltd. This Website is provided for pregnant women who have SMA and/or who have taken Evrysdi® (risdiplam) during pregnancy, to participate in the Evrysdi Pregnancy Registry (“study”).
We collect personally identifiable information from you (for example, your first name, last name, title and/or email address, mailing address, language preference, contact telephone number(s), and ZIP or postal code) that you provide to us through your use of the Website including in any of the ways explained below (“personally identifiable information”) and personal health information through direct user input as described below. If applicable, we may also receive information about how you use our Website through the automatic operation of “cookies”, web logs, and other technologies.
We will, on behalf of F. Hoffmann-La Roche Ltd., collect your full name, email address, and telephone number on the Website. We are also processing your sensitive personal data based on your pregnancy status and use of Evrysdi®. Providing your email address will allow an automated message to be sent to you to confirm the data you entered on the website form was received; no other emails will be sent without your consent. Your phone number is gathered by the North America Coordinating Center (the “Center”), so that it may call you to: (a) give you more information about the Evrysdi Pregnancy Registry itself; (b) determine if you are eligible to participate in it; and (c) discuss your interest in taking part over the phone. If you meet the eligibility criteria and express an interest in taking part in it, the Center will obtain your verbal consent and send you an email or mailing with a copy of the Informed Consent Form for your records, at which point you will be enrolled in the Evrysdi Pregnancy Registry. You will also receive a copy of a Medical Release Form, which must be read carefully, signed, and returned by email or mailed to the Center as instructed. This form allows the Center to contact your Healthcare Providers to provide pertinent data about you and your pregnancy, applicable to the Evrysdi Pregnancy Registry. During the call, you will be asked if you would like to participate in our communications program, where we send you information emails, and any upcoming scheduled calls related to the study.
This policy applies to all information received through the Website, both automatically and through direct user input. For example, we receive information in any of the following ways:
Registration is required for use of this Website. To enable us to generate your log-in to the Website, we will collect certain personally identifiable information from you (and we may also receive information from the clinical site that will allow us to generate a user ID specific to you). Once the user ID is generated you will receive an electronic message containing your individual ID and temporary password and you will need to log-in using those credentials in order to create a unique log-in password.
We use standard web logs that record basic data about people who visit our Website(s).
The following information may be contained in these logs:
We do not normally seek to identify individuals from web logs including from their IP address and we do not disclose them to others. However, web logs may be used to identify an individual who we have reason to suspect tried to damage our Website or use it in an unauthorized way. If we have reason to believe that there has been a violation of computer security or related laws, we may share our web logs with law enforcement agencies.
A cookie is a piece of data or a file that a website can send to your internet browser which may then store it on your computer. Cookies store information such as the pages you visited, the website features you used, and the amount of time you visited a particular webpage. They are also a means of keeping track of a user's preferences during a visit to a website. In order to provide persistence of a user’s preference, we store a unique identifier in a “temporary” or “session” cookie that only exists during the browser’s session with the website. When the user returns to the website, the identifier can be extracted from the session cookie and used to request detailed search information for that user from our database.
No cookies are used to track an identifiable individual's movement on the internet. They are only used to enhance the usability of the site.
Only to the extent applicable to your particular use of the Website, our uses of other technologies (“Technologies”) to automatically collect information through the Website fall into the following general categories:
The following cookies may be used on our Website:
Most browsers also allow you to block, disable and delete cookies. However, if you do that, the Website may not work properly. You always have the right to refuse the storage of cookies on your computer, or to disable and/or delete cookies at any time as your browser or device permits. It is important that you understand that if you block, disable or otherwise reject our cookies, you may not be able to use the Website or all of its interactive features or to use certain of its essential features. We suggest that you accept cookies because they allow you to get the most out of your Website experience, and to take advantage of some of the Website’s essential features.
For more information about the cookies we use, and to see what cookies have been set on your computer and how to manage, disable and delete them, visit www.allaboutcookies.org.
Where applicable at the request of the user, we forward personally identifiable information such as your name, year of birth, telephone number and/or email address and zip or postal code, and your personal health information and other information with your permission to the study concierge and/or patient guide at the medical center running the clinical trial in which you are interested or are participating. We also will share information about your participation in a clinical trial with the providers, researchers and others conducting the trial, consistent with the informed consent for the trial.
We may share any information we receive with vendors and service providers in order to support your participation in the clinical trial and permit us to provide our services in connection with clinical trials. The types of service providers (processors) to whom we entrust personal information include service providers for: (i) provision of IT and related services; (ii) provision of information and services you have requested; (iii) payment processing; (iv) customer service activities; and (v) in connection with the provision of the website. IQVIA has executed appropriate contracts with the service providers that prohibit them from using or sharing personal information except as necessary to perform the contracted services on our behalf or to comply with applicable legal requirements.
It is possible that we may need to disclose personally identifiable information about you in response to a law enforcement or national security request or legal process such as a search warrant, subpoena, or court order or in connection with an investigation or prosecution of suspected or actual illegal activity. Disclosures may also be made to comply with the law, protect our legal rights, or yours, or those of others’ including also property, or safety, to protect the security or integrity of our Website, to take precautions against liability, or during emergencies if physical safety is believed to be at risk, or if we, in good faith, believe that disclosure is otherwise necessary or advisable. These types of disclosures are unlikely, but they are possible and so we describe them here.
If applicable, we also may need to share information with regulators or others in government who oversee clinical trial activities, as described in the ICF and with the Sponsor of the study, F. Hoffmann-La Roche Ltd. In addition, from time to time, server logs may be reviewed for security purposes – e.g. to detect unauthorized activity on the services. In such cases, server log data containing IP addresses may be shared with law enforcement bodies in order that they may identify users in connection with their investigation of the unauthorized activities.
We combine and use non-personal information (aggregated data) e.g. from our web logs and other Technologies to study how the Website is being used. We will periodically analyze this aggregated data and use what we learn to make improvements to our website. In addition, we may share this aggregated data (which does not contain any information which can identify an individual) with our clinical research partners to assist them in better designing their websites or clinical trials.
In some situations, you may access, update, correct or remove the personal information you provided to us by sending an email to EvrysdiPregnancyRegistry@IQVIA.com. Your ability to correct, remove, or delete your personal information will depend in most situations on the informed consent agreement and the clinical trial protocol, which may require that information be maintained.
Non-identifiable information in our aggregate database will not be deleted. Like all responsible Websites, we maintain backup files as a protection against natural disasters, equipment failures, or other disruptions. Backup files protect you and us because they lessen the risk of loss of valuable data. Removing a record from our principal files does not remove that record from any of the backup systems. It may take up to 6 months before all information in a backup record is completely erased through the normal recycling of backup files. In the meantime, as long as backup records exist, they receive the same privacy and security protections as our other records.
You can ask us to provide you with information about and copies of your personal information that we keep by sending an email to EvrysdiPregnancyRegistry@IQVIA.com. You may also use this contact point for any other questions you may have about your rights in connection with your personal information, including the ability to request that we remove, delete or port (transfer) your personal information, and/or to ask that we correct or amend any inaccurate information. Please note that these rights are not automatic or absolute and may be subject to a fee, to the extent allowed by law and consistent with the ICF.
If you have any requests concerning your personal information or have any questions or comments about privacy, please send an email to EvrysdiPregnancyRegistry@IQVIA.com. Please include your contact information, the name of this website or service at issue, and a detailed description of your request or privacy concern.
Do Not Track (“DNT”) is a privacy preference that users can set in certain web browsers. DNT is a way for users to inform websites and services that they do not want certain information about their webpage visits collected over time and across websites or online services. Please note that we do not respond to or honor DNT signals or similar mechanisms transmitted by web browsers.
Processing personal information in a secure manner is essential to our business and for your protection as a user. Maintaining a secure network and server system is in the best interests of our users and our research partners. We process and store personally identifiable information using industry standard physical, technical, and administrative safeguards to secure such personal information against foreseeable risks such as unauthorized use, access, disclosure, destruction, and modification. Such security safeguards include use of encryption, password protection, and user authenticated access rights. While we will use reasonable efforts to create a secure, safe and reliable website, the confidentiality of any communication or material transmitted to or from the website over the internet cannot be guaranteed.
The security of your personal information is also, in part, your responsibility. When you register through the Website, you should select passwords that are hard to guess, and you must keep your passwords private and confidential. You should not share your password with anyone and should not store it in an unprotected format, such as taped to your computer or saved in your email. We do not accept liability for unintentional disclosure.
By using the Website or providing personal information to us, you agree that we may communicate with you electronically regarding security, privacy, and administrative issues relating to your use of the website. If we learn of a security system’s breach, we may attempt to notify you electronically by posting a notice on the website or sending an email to you. You may have a legal right to receive this notice in writing.
Protecting the privacy of the very young is especially important. This Website is not intended for or designed to attract minors. Users under the age of 18 or the age of legal majority in their country should not submit information to our Website, and we do not collect, receive or knowingly keep information from any user we know or have reason to believe is a child under the age of 18 or age of legal majority, unless the information is provided by a parent or guardian. If a child has provided us with personally identifiable information, the parent or guardian of that child should contact us if they want this information deleted from our files.
Users that are participating in pediatric trials will be asked to enter a date of birth. If the date of birth is under the age of 18 or legal majority in their country, the user will not be allowed to continue and submit the information unless that information is submitted by a parent or guardian.
The information you provide to us may be archived or stored periodically by us according to backup processes and will only be retained for as long as is required for the purposes for which it was collected, to provide our products and services to you, to support your participation in clinical trial activity, resolve disputes, establish legal defenses, conduct audits, pursue legitimate business purposes, enforce our agreements, and comply with applicable laws. Personal information collected as part of the Evrysdi Pregnancy Registry will be retained for the duration of the registry.
If any request remains unresolved, you may contact: IQVIA’s Privacy Office at PrivacyOfficer@iqvia.com.
For queries by post to IQVIA, please write to:
83 Wooster Heights Road, Danbury, CT 06810, USA
4820 Emperor Boulevard, Durham, North Carolina 27703, USA
Our Website may contain links to other third-party websites. You should carefully review the privacy policies or notices and practices of other websites, as we cannot control or be responsible for their privacy policies, notices or practices. For links to other company web properties, please review those privacy terms as well as they may differ from those on this Website.
Additionally, before we use personal information for any new purpose not originally authorized by you, we will endeavor to provide information regarding the new purpose and give you the opportunity to opt out. Where your consent for the processing of personal information is otherwise required by law or contract, we will endeavor to comply with the law or contract.
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