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This Privacy Policy is effective as of December 20, 2023.

Sarkis Clinical Trials provides this privacy policy (the “Privacy Policy”) to describe how we may collect, use, and share information that you and others provide us through our websites located at SarkisClinicalTrials.com and SarkisFamilyPsychiatry.com (collectively the “Site”).

This Privacy Policy applies only to Sarkis Clinical Trial's Website.

 

TABLE OF CONTENTS

This Privacy Policy includes the following topics.
 

 

  • Introduction

 

  • What is the role of Sarkis Clinical Trials in the Study?

 

  • What Personal Data do we collect and use?

 

  • Why do we collect and use Personal Data?

  • Who has access to Your Personal Data?

  • Confidentiality

  • Where is personal data stored?

  • How long do we retain your Personal Study Information?

  • How do we protect your Personal Study Information?

  • Access to Personal Study Information

  • Changes to this Privacy Information Notice

  •  Contact

Introduction

This privacy information notice (“Notice”) is intended to provide participants in clinical studies conducted by Sarkis Clinical Trials. (“SCT”) with an overview of the measures taken by Sarkis Clinical Trials to protect the privacy of the participants.

Sarkis Clinical Trials sponsors clinical studies under the control of the U.S. Food and Drug Administration (“FDA”) and other governmental authorities regulating the development of medicinal products (“Regulatory Authorities”).

When you participate in a clinical study conducted by Sarkis Clinical Trials (the “Study”), your participation is completely voluntary. Prior to participating, you must give informed consent in writing to the scope of the research to be conducted using your personal data gathered during the Study (“Personal Study Information”). This Personal Study Information may include, but is not limited to, your medical history, disease state (if applicable), information regarding biological samples (e.g. blood, urine, or tissue samples) and adverse events. (AEs)

All your personal data will be protected in accordance with the applicable data protection laws, which includes - for the European Economic Area (“EEA”) - the General Data Protection Regulation (“GDPR”) and for the United States - the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).

In this Notice, we explain what personal data will generally be processed as part of the study and what rights you have with respect to your privacy. For more information about the background, purpose, and operation of the Study, please see the Informed Consent Form or other information provided to you when you entered the clinical study.

 

What is the role of Sarkis Clinical Trials in the Study?

Sarkis Clinical Trials is responsible for processing and controlling personal study information. We will involve external parties such as contract research organizations (CROs), sites (i.e. the location where your study doctor is based) or other research organizations to process the study information.

 

What Personal Data do we collect and use?

For the purposes described in this Privacy Notice, we may collect the following information about you, including: 

  • Your name, email address and phone number and other contact details,

  • previous experience and other information regarding your participation in Clinical Studies within or outside of Sarkis Clinical Trials and the training you have received,

  • technical data related to your use of Sarkis Clinical Trials systems

Why do we collect and use Personal Data?

We need to process your Personal Study Information to draw conclusions from the result of the Study and to receive authorization from relevant Regulatory Authorities to market our pharmaceutical products. We may also publish the results of the Study.

We will only process personal data if we have a valid legal justification for doing so. Therefore, we will only process your Personal Study Information if:

Processing Purpose

Legal Basis

A.  To conduct studies at Sarkis Clinical Trials in accordance with good clinical practice (GCP) and applicable laws

Our legitimate interest in conducting clinical studies to test potential treatments in compliance with legal and regulatory regulations.

B.  To support applications for and to comply with the conditions of any marketing approval granted in respect of any medication studied under a Sarkis Clinical Trials Clinical Study (“Study Medication”).

Compliance with legal and regulatory obligations.

C. To support applications to vary the terms of any marketing approval granted in respect of a Study Medication.

D. To conduct research related to the development of pharmaceutical products, diagnostics, or medical aids.

E. To share information with other companies or industry organizations in the context of planning and conducting clinical trials.

Our legitimate interest in conducting clinical studies to test potential treatments in compliance with legal and regulatory regulations.

F.  To support recruitment of study participants

G. To comply with the US Financial Disclosure regulation, which is intended to ensure that financial interests and arrangements of clinical investigators that could affect the reliability of data submitted to the Federal Drug Administration of the U.S.A. (“FDA”) are identified and disclosed to the FDA¹ and other disclosure obligations as required by applicable laws and regulations.

Our legitimate interest in this purpose as well as compliance with legal and regulatory obligations

H. To ensure traceability and follow-up of drug safety notification.

Compliance with legal and regulatory obligations.

Who has access to Your Personal Data?

We do not share or otherwise transfer personal data to third parties other than those indicated in this Privacy Notice. Personal data may be accessed by or transferred to:

  • our personnel (including those in our Clinical Trial, Patient Safety, Medical Information, Quality Assurance, and Legal departments) and other Sarkis Clinical Trials;

  • our partners, e.g. pharmaceutical, medical device companies, and;

  • suppliers and services providers acting on behalf of Sarkis Clinical Trials companies, that provide services and products to us. These third parties are contractually obliged to protect the confidentiality and security of your Personal Data, in compliance with applicable laws. 

Personal data may also be shared with national and/or international regulatory authorities, other enforcement agencies, commissions, courts, or ethics committees, including if applicable those based in different jurisdictions, to comply with local laws, regulations, or pharmaceutical industry codes applicable to Sarkis Clinical Trials. For that reason, we may disclose information such as the Site’s and/or investigator’s name, Site contact information, name of the Clinical Study, sponsor, copy of the clinical trial agreement, and costs and fees relating to Site’s activities.  

 

Confidentiality

Your Personal Study Information is recorded using a unique study number to prevent your identity being revealed. The link between your unique study number and your identity is only known to your study doctor and is not provided to Sarkis Clinical Trials or made publicly available. All information to be held by Sarkis Clinical Trials as part of the Study is identified by this study number and not by your name. This is considered pseudonymized data. We will treat this data accordingly.

Where is Personal Data stored?

Clinical trials involve the collection of Personal Health Information (PHI) as defined under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its accompanying regulations within the US and “Personal Data” as defined by the GDPR within the European Economic Alliance (EEA). In nearly all cases, one or both privacy laws may govern data collection, use, and storage in the setting of clinical research.

We will ensure the protection of your Personal Data by (i) applying the level of protection required under the local data protection/privacy laws applicable in the country of destination, (ii) acting in accordance with our policies and standards and, (iii) for entities located outside of the United States, unless otherwise specified or required, by transferring your Personal Data on the basis of standard contractual clauses approved by the European Commission and the EEA.

How long do we retain your Personal Study Information?

Sarkis Clinical Trials will only retain personal data for as long as legally required to fulfill the purpose for which it was collected or to comply with regulatory or internal policy requirements. After such time periods have expired, we may either delete your personal data or retain it in a form such that it does not identify you personally.

 

How do we protect your Personal Study Information?

Sarkis Clinical Trials takes the security and privacy of Personal Study Information very seriously. We will therefore implement reasonable and appropriate security measures to protect your personal data from loss, misuse and unauthorized access, disclosure, alteration, and destruction.

 

Access to Personal Study Information

If you are participating in a Study, we strongly recommend that you request access to your Personal Study Information directly from your study doctor as explained to you via the Informed Consent Form or other information provided to you when you entered the clinical study process. As we only possess pseudonymized data, we cannot identify which Personal Study Information relates to you without asking your study doctor to reveal your identity and linking the pseudonymized data to you. This may violate applicable law regulating clinical studies and is not in your interest.

At your request, we will confirm whether your Personal Study Information is being processed in a Study and take measures to provide you with any of your personal data that is processed in such Study within a reasonable time. You have the right to access, correct, amend, or delete your personal data only in the event that it is inaccurate or has been processed in violation of this Notice. We may require payment or refuse your request if this request is manifestly unfounded or excessive, or if compliance with the request would conflict with our obligations under applicable law regulating clinical studies.

If you withdraw or are asked to be withdrawn from a Study, your Personal Study Information collected prior to your withdrawal may still be processed along with other Personal Study Information collected as part of the Study, as stated in the Informed Consent Form.

 

Changes to this privacy information notice

This Notice may be subject to amendments. Any future changes or additions to the processing of personal data as described in this Notice affecting you will be communicated to you through an appropriate channel, in line with how we normally communicate with you. How to contact us If you have any questions about this Notice, please e-mail us at

How can you contact us?

If you want to contact our Regulatory Affairs Manager, please email: 

privacy@SarkisClinicalTrials.com 

or write to:

Regulatory Affairs Office,

Sarkis Clinical Trials

611 NW 60th Street, Suite C,

Gainesville, FL 32607.

This Privacy Notice was last updated in December 2023.  Changes or additions will be notified through our usual communication channels (e.g. via SarkisClinicalTrials.com/privacy).

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