Study Participants, Legally Authorized Representatives, and Caregivers

Zelta Study Designers and Study EDC End Users

Zelta My Clinical Diary

This applies to study participants, legally authorized representatives, and caregivers who will login to Zelta My Clinical Diary to access eConsent or electronic patient reported outcomes (ePRO).

The Zelta™ platform (“Application”) is owned and operated by Merative U.S. LP (“Merative”) and is made available to you through a “Participating Organization” (e.g., Client, clinical trial sponsor or site), who has engaged Merative as an authorized third-party vendor.

You acknowledge and understand that a Participating Organization may also process your information you provided to Participating Organization (e.g., clinical trial participation information) through our Application in order for us to provide certain services on behalf of the Participating Organization. Each Participating Organization is the “controller” of such information, and Merative only processes such information on behalf of the Participating Organization. For more general information on how Participating Organization is processing your information, including their data retention policies, please refer to their privacy policy.

This Zelta Application Privacy Notice (“Notice”) applies only where Merative acts as a “controller” of your information and supplements the Merative Privacy Policy. By using the Application, you acknowledge that you have read and understand this Notice and our Privacy Policy. Please read each carefully. If you do not wish for your information to be processed as set forth in this Notice and our Privacy Policy, do not access the Application.

Information Collected: We collect and process the following information to create and maintain End User accounts on, and to maintain functionality of, the Application:

  • Identity Data (e.g., Your first name, last name and your email address).
  • You will select and provide the answers to three secret questions to be used for forgotten username or password retrieval, which may include user content or other personal information.

Purpose & Legal Basis: : We process your information in connection with the Application for the following purposes and related legal basis.

  • With your consent so Merative can provide the features and services you request, including creating and maintaining your account, and maintaining the service.
  • As necessary to fulfill legal obligations or to establish or defend legal claims.

Depending on Clients’ use of the Application, the following legal basis may be applicable:

  • As necessary for the vital interests of the individual.
  • As necessary for medicinal purposes or for the management of health systems or services, e.g., to enable healthcare treatment at the request of a health provider, or maintain health care records.
  • As necessary for reasons of public interest in the field of public health, e.g., to facilitate compliance with standards of quality and safety of healthcare and medicines.
  • As necessary for archiving purposes in the public interest or scientific of historical research purposes.

Cookies and similar technologies: The My Clinical Diary module uses only strictly necessary cookies and similar technologies (which do not directly identify you) to make sure the site works as intended. Merative does not use any information collected by the Zelta platform or the My Clinical Diary module for marketing activities. For general information about Merative’s corporate privacy policies and collection of data via cookies and similar technologies outside of the context of your use of the Application, see https://merative.com/privacy

Data Retention: Data will be retained and stored by Merative as required to comply with any legal and regulatory obligations (e.g., pursuant to judicial proceeding, court order, or legal process), including such obligations applicable to Participating Organizations, unless it has been anonymized and no longer contains personally identifiable information. We generally consider the following factors when we determine how long to retain data (without limitation):

  • Retention periods established under applicable law;
  • Industry best practices;
  • Whether the purpose of processing is reasonably likely to justify further processing;
  • Risks to individual privacy in continued processing;
  • Applicable data protection impact assessments;
  • IT systems design considerations/limitations; and
  • The costs associated continued processing, retention, and deletion.

Your Rights: For general information about Merative’s corporate privacy policies, including the rights you may have under applicable data protection laws, please see https://merative.com/privacy

Zelta Application End Users may also submit questions to Zelta support at zelta.support@merative.com.

Modifications: Merative reserves the right, at its sole discretion, to modify this Privacy Statement from time to time, and your continuing use of the Application constitutes your acceptance of and agreement to any changed terms and conditions.

Zelta Study Connect, Designer, and Teams Portal

Applies to Zelta users who will be CDMS/EDC study end users, study designers, and portal team members.

The Zelta™ platform (“Application”) is owned and operated by Merative U.S. LP (“Merative”) and is made available to you (“You”, “you” or “End Users”) through a “Participating Organization” (e.g., Client, clinical trial sponsor or site), who has engaged Merative as an authorized third-party vendor.

You acknowledge and understand that a Participating Organization may also process your information through the Application in order for us to provide certain services on behalf of the Participating Organization. Each Participating Organization is the “controller” of such information, and Merative only processes such information on behalf of the Participating Organization. For more general information on how Participating Organization is processing your information, including their data retention policies, please refer to their privacy policy.

This Zelta Application Privacy Notice (“Notice”) applies only where Merative acts as a “controller” of your information and supplements the Merative Privacy Policy. By using the Application, you acknowledge that you have read and understand this Notice and our Privacy Policy. Please read each carefully. If you do not wish for your information to be processed as set forth in this Notice and our Privacy Policy, do not access the Application.

Information Collected: We collect and process the following information to create and maintain End User accounts on, and to maintain functionality of, the Application:

  • Identity data, such as:
    • First/last name
    • User ID
  • Contact data, such as:
    • Email
  • Company name, organization type, role
  • Primary time zone
  • You will select and provide the answers to three secret questions to be used for forgotten username or password retrieval, which may include user content or other personal information.
  • Device/network information, such as:
    • IP address,
    • Device identifiers
  • Inference data, such as:
    • Usage analytics

Purpose & Legal Basis: We process your information in connection with the Application for the following purposes and related legal bases. The information collected within the Application is not used for any marketing activities, but to

  • As necessary to perform contract obligations, including:
    • To operate and maintain your account
    • To provide the services, features, and modules that you request
  • As necessary in connection with our legitimate interests, e.g. to:
    • Make sure the site works as intended
    • Support products or services
    • Fulfill your requests, as directed by you or by others involved in fulfillment
    • Personalize your experience while you are on our sites, make navigation easier
    • Web site usage statistics
    • To secure our services and related information security processes and procedures; and
    • If you are a Zelta Sponsoring Organization, we may contact you for customer satisfaction surveys or in connection with certain transactions.
  • As necessary to fulfill our legal obligations or establish or defend legal claims

Cookies and similar technologies: Merative may also collect information relating to your use of our Web sites through various technologies, including cookies. For general information about Merative’s corporate privacy policies and collection of data via cookies and similar technologies, see https://merative.com/privacy

Data Retention: Data will be retained and stored by Merative as required to comply with any legal and regulatory obligations (e.g. pursuant to judicial proceeding, court order, or legal process), including such obligations applicable to Participating Organizations, unless it has been anonymized and no longer contains personally identifiable information. We generally consider the following factors when we determine how long to retain data (without limitation):

  • Retention periods established under applicable law;
  • Industry best practices;
  • Whether the purpose of processing is reasonably likely to justify further processing;
  • Risks to individual privacy in continued processing;
  • Applicable data protection impact assessments;
  • IT systems design considerations/limitations; and
  • The costs associated continued processing, retention, and deletion.

Your Rights: For general information about Merative’s corporate privacy policies, including the rights you may have under applicable data protection laws, please see https://merative.com/privacy

Zelta Application End Users may also submit questions to Zelta support at zelta.support@merative.com.

Modifications: Merative reserves the right, at its sole discretion, to modify this Privacy Statement from time to time, and your continuing use of the Application constitutes your acceptance of and agreement to any changed terms and conditions.