This Privacy Policy is provided to you by CorEvitas, LLC (“CorEvitas”, “we”, “our”). If you are reading this, it means that you are on one of our websites.

About us

We are a global company. Our headquarters are in the United States. You can find all our details here. Protecting your information is important to us. This Policy explains how we deal with your information , how we protect it and how we interact with you. There is some important information about the information we collect about you and your rights in this Policy, so please take the time to read and understand it.

This Privacy Policy describes how CorEvitas processes the information relating to individuals who have enrolled in our studies as participants as well as to visitors to our websites.

Updating this Privacy Policy

CorEvitas reserves the right to modify this Privacy Policy at any time by posting updated versions on its websites. Such versions shall take effect from the date of posting.

Why do we process your information?

Our primary reason for processing your information is to allow CorEvitas to identify individuals who have voluntarily joined CorEvitas studies as participants.

Your information is exclusively processed under the scope and purpose of the services described in this Privacy Policy.

About the Sponsor

We are the Sponsor. We may at any one time be conducting epidemiological studies and surveys on a variety of topics about or related to pregnancy and babies. It is possible that participants may enroll in one or more studies simultaneously. Pharmaceutical companies that hold marketing authorizations for a particular product or products may act as financial contributors to a particular study. However, you should know that where that is the case, your name and other directly identifying information are never shared by CorEvitas with those entities. Instead you will only be identified by a code.

Questions

Please direct your questions or concerns or complaints to the study’s Principal Investigator at RSV@corevitas.com. You may also call the Study Team at 1-800-616-3791 (US and Canada only).

What we do

Here we explain to you what we do (our services).

CorEvitas’ services consist of allowing pregnant women to participate in our studies and to provide information and support to those participants. Our services are listed below.

Study Participation

Individuals are screened when joining a study. We ask them certain questions to determine their eligibility for that study. If eligible, a form is then made available for those individuals to input their data. The individual provides a name, phone number and creates a user login (username, email and a password) if they choose to complete forms directly in the website. After verification of the individual by means of a one-time password, a consent form is made available to the individual to read. If they wish to continue to join the study, they are asked to confirm that they understand it by signing it. If you are that individual, you should know that it is your free choice whether or not to sign this form, join the study and become a registered user.

Registered users are then re-directed to the registration stage where they are asked to enter information related to the specific study where they may share their information.

After a profile is established, participants are asked some questions for the duration of the study. They may share their information here as well.

Information collected about you may consist of:

• Name
• Email 1
• Enrolment ID
• Age
• Preferred Language
• Time Zone
• Phone number
• Phone number 2 (optional)
• Source
• IP Address
• Signature
• Login (password)
• Geolocation
• Region
• Country
• City
• Postal Code
• Medical history and details (optional)
• Race/Ethnicity
• Call recordings

Information Sharing

CorEvitas, its affiliates, and people and companies that it works with on the Registry will have access to and use your coded data and your infant’s coded data to conduct the research described in this form. This coded information may be used by CorEvitas or shared for future research studies without the need to have you informed and aware or to gather your consent for that purpose. Neither the researchers for future studies nor the RSV Vaccine Pregnancy Registry’s Study Team members will know who you are from the shared data.

Efforts will be made to limit the use and disclosure of your information to people who need to review this information. We cannot promise complete confidentiality. The study data may be given to the authorities who approve medicines (like the Food and Drug Administration located in the USA). These authorities, WCG Institutional Review Board (IRB, a group of people who perform independent review of research and help to protect the rights of people who are part of a research study), study staff of CorEvitas and its affiliates or people and companies that work with CorEvitas, including PPD (both CorEvitas and PPD are part of Thermo Fisher Scientific) , and an auditing group may inspect the study data files. Additionally, study data may also be shared with healthcare providers. None of these data will identify you or your infant by name.

Your full name and email address will be shared with a company named Scout, who will be providing you with payment for your study activities (as described in the “Payments” section below).

The study findings for all study participants in total may be published or discussed at professional meetings. Expert doctors will also help us to understand the results of your data and your infant’s data collected by the study.

Study data that are published or otherwise shared publicly will never identify you, your infant, or any other individual participant by name or any other information which could be used by anyone outside of the Study Team or your or your infant’s doctor(s) to identify you.

Cookies

We gather information about you directly from you at study enrollment and through your actions and interactions with us. When you use a CorEvitas website, a session cookie file may be placed on your browser device.

For website visitors, CorEvitas uses Cookies. Please check that you have set your preferences in the cookie management tool. You should be aware that, in some cases, the data collected in this way may make it possible for third parties to identify an individual who has accessed the website. You should disable nonessential cookies if you wish to avoid this. CorEvitas only uses cookies that record information about the IT architecture and landscape of the device being used by the visitor (e.g., browser, device, etc.). However, that visitor is never identified personally by us. IP addresses are cross-referenced with other data for the purpose of safeguarding both CorEvitas, the study results, and the participants from fraud attempts.

Storing information

The information we hold is maintained in a digital format on our IT systems hosted in the United States at Amazon Web Services (AWS).
Data in transit and at rest are encrypted.

Recordings

In addition to interaction via the platform or by email, designated CorEvitas staff may speak with you over the phone using the software Aircall. Due to operational reasons, the phone calls are recorded and stored by CorEvitas, unless you expressly refuse the recording at the beginning of the call.
You always have the option to refuse recordings.

Aircall saves fully encrypted calls in the European Union. If you wish to know more, you should refer to Aircall’s own Privacy Policy. You should avoid sharing any information that either do not relate to you or to your child or that are irrelevant to the study when speaking to CorEvitas staff over the phone.

Data Minimization

CorEvitas takes all reasonable steps to ensure that the information that it collects is limited to the amount and type that is necessary for the successful execution of the studies.

Security, Privacy, and Confidentiality Assurance

Consistent with applicable laws and requirements, CorEvitas has put in place physical, technical, and administrative safeguards to protect Personal Data from loss, misuse, alteration, theft, unauthorized access, and unauthorized disclosure consistent with legal obligations and industry practices.

Retention

CorEvitas determines the data retention period according to applicable laws and by reference to the duration of each study. CorEvitas does not hold your information for longer than strictly necessary. Additionally, CorEvitas ensures that the risk of information being deleted prior to the end of its lifecycle is minimized.

Your data rights

You may have a right under your area’s data protection law to the following rights with respect to some or all of your information:

• To request access to your information
• To request that we rectify or erase your information

You can make a request with respect to your information by contacting the Principal Investigator.

Version Date: 26 April 2024