Clinical Trial Privacy Notice (GDPR)

Who we are?

Sagimet Biosciences Inc. (“Sagimet Biosciences”) is a clinical stage pharmaceutical company operating from 155 Bovet Road, Suite 303, San Mateo, CA 94402, USA.

Your Privacy

This notice provides information for individuals whose personal data has been collected by Sagimet Biosciences, whilst acting as the sponsor of a clinical trial taking place in the United Kingdom (“UK”) or European Economic Area (“EEA”). Under these circumstances we fall within scope of the General Data Protection Regulations (“GDPR”). As the sponsor of clinical trials in the UK or EEA, we will be obligated as the data controller for the study data generated, to determine the purposes and means of processing Personal Data, which under the GDPR is defined as “any information relating to an identified or identifiable natural person (i.e. data subject).”

Your privacy matters to us and we are committed to meeting regulatory data privacy standards and confidentiality.

Main Categories and Type of Personal Data Collected and processed in clinical trials

Below are details on the main categories and types of personal data collected and processed by Sagimet Biosciences.

As a clinical stage pharmaceutical company, we collect various types of data from trial subjects. This data is pseudonymized and we are unable to identify subjects from this.  Access to identifiable personal data will only be by the site/hospital/clinic at which you as the trial subject attended. The types of data that we may collect from trial subjects includes but is not limited to:

  • Subject Identifiers
  • Age, Sex, and Ethnicity
  • Health and Medical Information
  • Blood Samples
  • Urine Samples
  • Tissue Biopsies

The study data will not be kept for longer than is necessary. To comply with the laws relating to clinical trials, this may be for up to 25 years. Details of how long study data is retained for is specific to each trial, and specific information can be found in the Patient Information Sheet provided to trial subjects.

We collect and process study data on the basis of legal requirements and in the interest of public health. All study subjects will have been provided information on the processing of their personal data when consenting to take part in the trial.

During clinical trials we will also collect the personal data of staff conducting the study on our behalf.

The types of data that we may collect from trial staff includes but is not limited to:

  • Names, contact details, and work address
  • Qualifications, experience, and training
  • Financial declarations and details

We collect and process this personal data on the basis of a contractual relationship and will only retain this data outside of the study data for future use with consent. All data related to the trial is retained in accordance with clinical regulations and could be up to 25 years.

Collection of online identifiers for analytical purposes

When you use our website, we collect certain information by automated means, such as cookies and web beacons. A “cookie” is a text file that websites send to a visitor’s computer or other Internet-connected device to uniquely identify the visitor’s browser or to store information or settings in the browser. We also use third-party analytics tools (such as Google Analytics) that collect information about use of the website and user traffic. The information we may collect by automated means may include, without limitation:

  • Cookie information
  • IP address
  • Device ID
  • Session ID
  • Interaction history

You should be aware that analytical “Cookies” may remain on your device for a number of years but can be removed through the settings controls within your browser, if so desired. 

Sharing of Personal Data

Sagimet Biosciences may pass the clinical trial study data on to service providers contracted to provide specialist functions, such as, safety monitoring, statistical analysis, report writing etc. Our service providers are under contract with us and have provided sufficient guarantees that they will process your data only as per the terms of that contract and throughout processing activities will ensure your data is protected using appropriate technical and organisation measures. Once your data is no longer needed to fulfil the service, they will dispose of the details in line with the agreements they have with Sagimet Biosciences.

A full list of processors is available upon request.

Where necessary or requested, we may disclose your information to relevant regulatory bodies or agencies responsible for the regulation of clinical trials.

UK and EU Data Subjects – International Data Transfers

In some instances, we may transfer your personal information to service providers or suppliers located in countries situated outside of the UK and EEA.

If the recipient is situated in a country that has not received an adequacy decision from the relevant UK or EU regulator, we will ensure additional safeguards are in place including the use of applicable standard contractual clauses.

Securing and Processing of your Personal Data

To provide and manage our services, your electronic data is stored and processed by internal and external systems. All of our systems have appropriate security processes in place. These systems can differ with each trial. If you would like more information on the security measures in place for the system that your data is stored on, please contact us with details of the trial at SagimetDPO@clinicaldpo.com.

Your rights in relation to personal data

Sagimet Biosciences conducts trials across the world and abides with the GDPR and any applicable local data protection laws in UK and EEA countries. Each country’s laws provides its residents with rights to their data, which include but are not limited to:

Right Explanation
Right to be Informed This means that we have to be transparent in how we collect and use your personal data.
Right of Access You have the right to access your personal data.
Right to Rectification If the information we hold about you is inaccurate or incomplete you can request that we correct this.
Right to Erasure You can request that we delete or remove personal data in certain circumstances (not applicable to clinical trial study data).
Right to Restrict Processing

You have the right to request that we cease processing your data if

  • you consider it inaccurate or incomplete and/or
  • you object to the reason we’re processing your data

We will review the validity of your request and respond to you with our decision.

Right to Data Portability Where you have consented to our processing your data or where the processing is necessary for us to deliver a contract you can request a copy of that data be provided to a third party.
Right to Object You have the right to object to our processing in certain circumstances.
Rights relating to Automated Decision-Making including Profiling

We do not use automated decision-making or profiling
Where automated decision-making is applied, organisations must

  • give you information about the processing
  • introduce simple ways for you to request human intervention or challenge a decision
  • carry out regular checks to make sure that our systems are working as intended

How to exercise these rights?

If you took part in a clinical trial as a study subject, you should ideally contact the institute where your trial took place (as we will not be able to identify you from the study data). Contact details will have been provided in your Informed Consent Form or Patient Information Sheet. Alternatively, you can contact us directly using the details below.

If you took part in a clinical trial as part of the study team, please contact us using the details below to exercise your rights.

Name: Amicis Data t/a Clinical DPO
Position: Data Protection Officer
Contact E mail: SagimetDPO@clinicaldpo.com

If you are unhappy with anything we have done with your data, you have the right to complain to the relevant supervisory authority in your country.

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