Privacy Notice for Clinical Trial Site Personnel (Feasibility Stage, Selection and Participation)

Effective: June 2022

This Privacy Notice is addressed to:

  • Personnel involved in either feasibility and/or selection, including trial site set-up, and participation of Novartis’ clinical trials.

Novartis will process information about you which constitutes “personal data”. At Novartis we are committed to the responsible use of your personal data and consider privacy a very important matter.

For the purposes of this Privacy Notice, “Novartis” refers to Novartis Pharmaceuticals UK Limited, which is registered at The WestWorks Building, White City Place, 195 Wood Lane, London W12 7FQ. In this Privacy Notice, references to “we” or “us” refers to Novartis as defined in this Privacy Notice.

Novartis is the “controller” as it is the entity that decides why and how your personal data is processed in the context of clinical trials sponsored by Novartis in the UK, or one of our affiliates such as Novartis Pharma AG or Novartis AG (“NVS Clinical Trials”). It may exercise this responsibility alone or jointly with other companies in the Novartis group (acting as a “co-controller”).

The purpose of this Privacy Notice is to provide you with transparent information on how Novartis collects, uses, and discloses your personal data in the context of NVS Clinical Trials.

You are receiving this Privacy Notice as Novartis is either: (i) conducting a feasibility study, to assess whether the site where you work (“Site”) is suitable to be selected for a NVS Clinical Trial (the “Feasibility Stage”); or (ii) following the Feasibility Stage, Novartis has selected the Site and is conducting a NVS Clinical Trial at the Site (“Participating Site”). We invite you to carefully read this Privacy Notice, as it contains important information for you regarding how we handle your information in both contexts.

Should you have any further questions or concerns in relation to the processing of your personal data, including which Novartis entity is processing your personal data, we invite you to contact [email protected].

1. Collection of personal data

This personal information may either be directly provided by you or provided by the Site (i.e. the legal entity you work for or on behalf of).
For the purposes described in this Privacy Notice, we will collect the following information about you including:

  • name,

  • address

  • telephone number

  • email address

  • your institution name e.g. NHS Trust Name, GP Surgery, etc.

  • research experience (details gathered within feasibility questionnaire)

  • previously recruited trials (details gathered within feasibility questionnaire)

  • ongoing or planned trials (details gathered within feasibility questionnaire)

  • GMC registration

  • present/previous appointments(s),

  • qualifications,

  • number of articles published,

  • the information contained in the CV provided to us,

  • previous experience in clinical trials and type of GCP training received,

  • financial interests in any companies of the Novartis group.

This personal information will be processed on the basis that it is necessary for our legitimate interests and those of the sponsor in conducting Feasibility or NVS Clinical Trials at Participating Sites. Where applicable, we may also process this personal data on the basis that it is necessary to perform our contractual obligations towards the Site, or where it is necessary to comply with our legal or regulatory obligations.

2.    Use of personal data

The above personal data will be processed for the following purposes:

  • in order to assess suitability to conduct a NVS Clinical Trial (i.e. the Feasibility Stage),

  • in order to conduct NVS Clinical Trials in accordance with good clinical practice and applicable laws,

  • to support applications for marketing approval of any medication studied under a NVS Clinical Trial (“Study Medication”),

  • to support applications to vary the terms of any marketing approval granted in respect of a Study Medication,

  • to comply with the conditions of any marketing approval granted in respect of Study Medication,  

  • to carry out research related to the development of pharmaceutical products, diagnostics or medical aids,

  • 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 FDA.1 

If applicable to a NVS Clinical Trial, where the Site has been selected to conduct a NVS Clinical Trial, your personal data (name and contact information) may be incorporated in subject recruitment advertisements (print media or on Internet). Any such advertisement would be approved by the Ethical Committee before it is made public. For the avoidance of doubt, your personal information will not be processed in this context where the Site has undergone the Feasibility Stage and is not, or has not become, a Participating Site.

3. Sharing of personal data

We will not sell, share, or otherwise transfer your personal data to third parties other than those indicated in this Privacy Notice. In the course of our activities and for the purposes listed in this Privacy Notice, your personal data can be accessed by, or transferred to the following categories of recipients, on a need to know basis to achieve such purposes:

  • the sponsor,

  • our personnel (including personnel, departments, or other companies of the Novartis group),

  • our independent agents or brokers (if any),

  • our suppliers and services providers that provide services and products to us,

  • our IT systems providers, cloud service providers, database providers and consultants,

  • our business partners who offer products or services jointly with us or with our subsidiaries or affiliates,

  • any third party to whom we assign or novate any of our rights or obligations,

  • our advisors and external lawyers in the context of the sale or transfer of any part of our business or its assets.

The above third parties are contractually obliged to protect the confidentiality and security of your personal data, in compliance with applicable law.

Your personal data can also be accessed by or transferred to any national and/or international regulatory body, or Ethics Committee where necessary in order to fulfill the purposes outlined above.

The personal data we collect from you may also be processed, accessed or stored in a country outside the UK, which may not offer the same level of protection of personal data. If we transfer your personal data to external companies in other jurisdictions, we will make sure to protect your personal data by: (i) applying the level of protection required under the local data protection/privacy laws applicable to the UK; and (ii) acting in accordance with our policies and standards. 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 intra-group transfers of personal data, the Novartis group has adopted Binding Corporate Rules, a system of principles, rules and tools, 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. Further information regarding the Novartis Binding Corporate Rules is located at:  https://www.novartis.com/privacy/novartis-binding-corporate-rules-bcr

4. Duration of storage

We will only retain your personal information for as long as necessary to fulfil the purpose for which it was collected or to comply with legal or regulatory requirements.

Novartis will generally retain your personal information for a period of up to 12 months after the Sponsor publishes the clinical study report pertaining to the NVS Clinical Trial for which your data was collected, unless we need to retain the personal information longer to comply with legal or regulatory requirements. Furthermore, some of your personal information may be contained within clinical trial documentation, which we eventually archive and retain on an on-going basis. Please note that we are required to retain clinical trial documentation for a minimum of 25 years.

5. What are your rights and how can you exercise them?

You may exercise the following rights under the conditions and within the limits set forth in the law: 

  • the right to be informed about what personal information we have about you and how we process your personal information;

  • the right to access your personal information as processed by us and, if you believe that any information relating to you is incorrect, obsolete or incomplete, to request its correction or updating;

  • the right to request the erasure of your personal information or the restriction thereof to specific categories of processing;

  • the right to withdraw your consent at any time, without affecting the lawfulness of the processing before such withdrawal;

  • the right to object, in whole or in part, to the processing of your personal information. With certain exceptions, this includes the right to object to direct marketing and the right to object to your personal information being used for research;

  • the right to request its portability, i.e. that the personal information you have provided to us be returned to you or transferred to the person of your choice, in a structured, commonly used and machine-readable format without hindrance from us and subject to your confidentiality obligations; and

  • the right to object to automated decision-making including profiling, i.e. you can request a human intervention in any automated decision-making process related to processing of your data and where such processing is not based on your consent, authorised by law or necessary for the performance of a contract. However, we don’t currently make decisions using automated processes only that result in significant or legal effects on individual.

Please note that Novartis UK is subject to legal and regulatory obligations which may limit or restrict the enforcement of your rights on some occasions. If you wish to contact us regarding our use of your personal data or you wish to exercise your data privacy rights, you may send an email to [email protected]

If you are not satisfied with how we process your personal data, please address your request to our Data Protection Officer at [email protected], who will investigate your concern.

In any case, you also have the right to file a complaint with the Information Commissioner’s Office (ico.org.uk), in addition to your rights above. Making a complaint will not affect any other legal rights or remedies that you may have.

6. How will you be informed of the changes to our Privacy Notice?

Any future changes or additions to the processing of your personal data as described in this Privacy Notice will be notified to you in advance through our usual communication channels (e.g. by email or via our websites).

Reference

1 Clinical investigators (principal investigator, sub-investigator or co-investigator) who are directly involved in the treatment or evaluation of research subjects in NVS Clinical Trials affected by this law, must disclose information to Novartis regarding their financial interests in companies belonging to the Novartis group as well as those of their spouse and each dependent child.

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