Clin’form Solution and Services Privacy Policy

The data collected in Clin’form Solution is governed by specific Data Processing Agreement with the Clinical Trial Sponsor, (identified as the “Sponsor” in the rest of this document) in the context of the clinical services provided and the Sponsor protocol, and in compliance with good clinical practices and laws and regulations applicable to clinical trials.

Kayentis is committed to strictly apply the terms of this agreement.

We collect data when you:

• Connect to Clin’form Solution  via a provisioned device
• Log in to the Clin’form Solution
• Perform training in Clin’form Solution
• Respond to electronic Clinical Outcome Assessment (eCOA) questionnaires included in the Study protocol
• Participate in a televisit with your clinical site personnel if applicable
• Call Kayentis helpdesk

Kayentis collects and/or processes the following data:

• Study participant identification number, or randomization number
• Health data collected via eCOA (electronic Clinical Outcome Assessment) questionnaires, associated audit trails, and any associated scores as defined in the Study Protocol
• Year of Birth
• Computer or Mobile Device ID
• IP address
• Other attributes, such as gender or ethnic origin, are only collected if required by the Sponsor Study protocol

The data collected by Kayentis Clin’form Solution is considered sensitive personal data and is pseudonymized (Directly identifying data is replaced by an ID code). Kayentis does not hold the keys to re-identify the patient.

We use your personal data to deliver the services agreed upon with the Sponsor, throughout the course of the Study:

• To analyze the data collected and to detect any potential inconsistencies, or missing data
• To track compliance with the Study protocol
• To troubleshoot and investigate any potential issues such as log-in/ password issues, device or connectivity issues
• To address queries with the Clinical sites
• To transfer data to the Sponsor or other third party, as directed by the Sponsor
• To provide reports as requested by the Sponsor
• To support audit and inspection requests
• To enhance Clin’form Solution and Services in order to improve user experience.

Personal data may be accessed by or transferred to:

• Kayentis Personnel, including Kayentis subsidiaries
• Suppliers and service providers acting on behalf of Kayentis. These third parties are contractually obliged to protect the confidentiality and security of your Personal Data, in compliance with applicable laws. Note that Kayentis will not share or transfer collected data with third parties unless specifically authorized by the Sponsor, or unless specified in the Study Work-Order.

Personal data may be processed, accessed, or stored in a country outside the country where you are located, which may not offer the same level of protection of personal data. If we transfer your Personal Data to other jurisdictions, we will make sure to protect your Personal Data by:

• applying the level of protection required under the local data protection/privacy laws applicable in the country of destination,
• acting in accordance with our policies and standards and,
• for entities located in the European Economic Area (i.e. the EU Member States plus Iceland, Liechtenstein and Norway, the “EEA”), unless otherwise specified or required, by transferring your Personal Data on the basis of standard contractual clauses approved by the European Commission. You may request additional information in relation to international transfers of Personal Data and obtain a copy of the adequate safeguard put in place by exercising your rights as described below.

For transfers of Personal Data to Kayentis wholly-owned subsidiaries, Kayentis has adopted Standard Contractual Clauses provided by European law, in an effort to ensure effective levels of data protection relating to transfers of Personal Data outside the EEA and Switzerland.

Study data are hosted in data centers in France unless the Study requires otherwise. Alternate data centers can be located in the European Union for emergency restoration purposes.

We will keep your Personal Data as long as needed for legal and regulatory requirements applicable to clinical trials and as directed by the Sponsor.

Please note that in certain countries, we may be required to retain Clinical Study Documentation for a minimum of 25 years.

Should you wish to exercise any of the following rights, we will forward your request to the Sponsor for further processing, in accordance with the agreement between Kayentis and the Sponsor.

• Right to access your personal data and, if you believe that it is incorrect, obsolete or incomplete, to request that it is corrected or updated;
• Right to request the erasure of your personal data or the restriction of its use;
• Right to withdraw your consent at any time, without affecting the lawfulness of the processing based on consent before such withdrawal;
• Right to object, in whole or in part, to the processing of your personal data; and
• Right to request portability of your personal data (i.e. for it to be returned to you or transferred to the person of your choice, in a structured, commonly used and machine-readable format).

We may apply exceptions to these rights where appropriate and in accordance with local law.

If you have a question or want to exercise the above rights, please contact Kayentis Data Protection Officer dpo@kayentis.com, who will forward this request to the Study Sponsor.

In any case, you also have the right to file a complaint with your local Data Protection Authority, or contact Kayentis DPO at dpo@kayentis.com to identify authorities contact information.

Kayentis reserves the right to modify this data privacy policy so that it remains compliant with the current legal requirements, or in order to implement changes to our services. The new data privacy policy will then apply at next log-in to Clin’form.

Your continued use of Clin’form Solution after the posting of any modified Privacy Policy indicates your acceptance of the terms of the modified Privacy Policy.

You can contact Kayentis Data Protection Officer at dpo@kayentis.com

Kayentis
Data Protection Officer
19 bis Chemin du Vieux Chêne
38240 Meylan – France
+33 (0)4 76 00 54 20

The data collected in Clin’form Solution is governed by specific Data Processing Agreement with the Sponsor (identified as the “Sponsor” in the rest of this document), in the context of the clinical services provided and the Clinical Trial Sponsor protocol, and in compliance with good clinical practices and laws and regulations applicable to clinical trials.

Kayentis is committed to strictly apply the terms of this agreement.

We collect data when you:

• Connect to Clin’form Solution via a provisioned device
• Log in to the Clin’form Solution
• Perform training in Clin’form Solution
• Respond to electronic Clinical Outcome Assessment (eCOA) questionnaires included in the Study protocol
• Initiate or respond to queries with Kayentis personnel or Kayentis sub-contractors
• Initiate a televisit with a study participant if applicable
• Call Kayentis helpdesk
• Interact via e-mail or other platforms with Kayentis personnel or sub-contractors.

For Clin’form users who are not study participants (patients or caregivers), Kayentis processes the following data in the course of providing clinical services as per contract with the Clinical Trial Sponsor:

• Name, function, organization name, email address, telephone number, mailing address
• User account information
• Computer or Mobile device ID
• IP address
• Audit trails of data submitted via Clin’form Solution

We use your personal data to deliver the services agreed upon with the Sponsor throughout the course of the Study:

• To ship the device to the clinical sites
• To analyze the data collected and to detect any potential inconsistencies, or missing data
• To track compliance with the Study protocol
• To troubleshoot and investigate any potential issues such as log-in/ password issues, device or connectivity issues
• To address queries with the Clinical sites
• To transfer data to the Sponsor or other third party, as directed by the Sponsor
• To provide reports as requested by the Sponsor
• To support audit and inspection requests
• To enhance Clin’form Solution and Services in order to improve user experience.

Personal data may be accessed by or transferred to:

• Kayentis Personnel, including Kayentis subsidiaries
• Suppliers and service providers acting on behalf of Kayentis. These third parties are contractually obliged to protect the confidentiality and security of your Personal Data, in compliance with applicable laws. Note that Kayentis will not share or transfer collected data with third parties unless specifically authorized by the Sponsor, or unless specified in the Study Work-Order.

Personal data may be processed, accessed, or stored in a country outside the country where you are located, which may not offer the same level of protection of personal data. If we transfer your Personal Data  to other jurisdictions, we will make sure to protect your Personal Data by:

• applying the level of protection required under the local data protection/privacy laws applicable in the country of destination,
• acting in accordance with our policies and standards and,
• for entities located in the European Economic Area (i.e. the EU Member States plus Iceland, Liechtenstein and Norway, the “EEA”), unless otherwise specified or required, by transferring your Personal Data on the basis of standard contractual clauses approved by the European Commission. You may request additional information in relation to international transfers of Personal Data and obtain a copy of the adequate safeguard put in place by exercising your rights as described below.

For transfers of Personal Data to Kayentis wholly-owned subsidiaries, Kayentis has adopted Standard Contractual Clauses provided by European law, in an effort to ensure effective levels of data protection relating to transfers of Personal Data outside the EEA and Switzerland.

Study data are hosted in data centers in France unless the Study requires otherwise. Alternate data centers can be located in the European Union for emergency restoration purposes.

We will keep your Personal Data as long as needed for legal and regulatory requirements and as directed by the Sponsor.

Please note that in certain countries, we may be required to retain Clinical Study Documentation for a minimum of 25 years.

Should you wish to exercise any of the following rights, we will forward your request to the Sponsor for further processing,  in accordance with the agreement between Kayentis and the Sponsor.

• Right to access your personal data and, if you believe that it is incorrect, obsolete or incomplete, to request that it is corrected or updated;
• Right to request the erasure of your personal data or the restriction of its use;
• Right to withdraw your consent at any time, without affecting the lawfulness of the processing based on consent before such withdrawal;
• Right to object, in whole or in part, to the processing of your personal data; and
• Right to request portability of your personal data (i.e. for it to be returned to you or transferred to the person of your choice, in a structured, commonly used and machine-readable format).

We may apply exceptions to these rights where appropriate and in accordance with local law.

If you have a question or want to exercise the above rights, please contact Kayentis Data Protection Officer dpo@kayentis.com, who will forward this request to the Study Sponsor.

In any case, you also have the right to file a complaint with your local Data Protection Authority, or contact Kayentis DPO at dpo@kayentis.com to identify authorities contact information.

Kayentis reserves the right to modify this data privacy policy so that it remains compliant with the current legal requirements, or in order to implement changes to our services. The new data privacy policy will then apply at next log-in to Clin’form.

Your continued use of Clin’form Solution after the posting of any modified Privacy Policy indicates your acceptance of the terms of the modified Privacy Policy.

You can contact Kayentis Data Protection Officer at dpo@kayentis.com

Kayentis
Data Protection Officer
19 bis Chemin du Vieux Chêne
38240 Meylan – France
+33 (0)4 76 00 54 20