This privacy notice is addressed to: 

  • Clinical investigators (principal investigators, sub-investigators or co-investigators);
  • Other site staff such as nurses, pharmacists or technicians, whose Personal Data may be processed in the course of the clinical trials and studies sponsored or organized by Novartis.

 You are receiving this Privacy Notice because Novartis Pharma AG (“Novartis”, “we” or “us”) will process information about you, which constitutes “Personal Data.” 

This privacy notice is provided to you to ensure transparency in relation to collection, use and disclosure of your Personal Data by Novartis for purposes related to the conduct of clinical trials and non-interventional studies (collectively “Clinical Studies”) sponsored or organized by Novartis Pharma AG (“Novartis Clinical Studies”) and/or its affiliates which are being carried at your Clinical Trial Site (the “Site”). For the purposes described in this Privacy Notice, Novartis is responsible for the processing of your Personal Data acting as a “Controller”. 

We invite you to read this Privacy Notice carefully, as it contains important information. Should you have any further questions, we invite you to contact [email protected]

Novartis Pharma AG designated Novartis Pharma S.A.S., 8-10, rue Henri Sainte-Claire Deville, 92563 Rueil Malmaison, France as its representative in the European Union.


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: 

  • name, identification number, address and other contact details,
  • financial information (e.g. bank account number, financial interests in any of the Novartis Group companies),
  • qualifications, publications and information contained in the CV you provide to us where necessary,
  • previous experience and other information regarding your participation in Clinical Studies within or outside of Novartis and the training you have received,
  • technical data related to your use of Novartis IT systems.


Why do we collect and use Personal Data?


Your Personal Data may be used by us for the purposes and on legal bases specified below. 

Processing purpose

Legal basis

1. To conduct Novartis Clinical Studies in accordance with good clinical practice and applicable laws.

Our legitimate interest in conducting Clinical Studies to test potential treatments as well as compliance with legal and regulatory obligations;

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

Compliance with legal and regulatory obligations.

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

Our legitimate interest in conducting Clinical Studies to test potential treatments.

4. To carry out research related to the development of pharmaceutical products, diagnostics or medical aids and improve Clinical Study practice.

5. To inform you, plan and/or conduct other Clinical Studies including to identify suitable investigators for our studies.

6. To share information with other companies or industry organizations in the context of planning and conducting Clinical Studies.

7. To assess the effectiveness of the sites participating in our studies.

8. To support recruitment of study subjects (for this purpose your name and contact information may be used for study advertisements in print and online media).

9. 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.

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

Compliance with legal and regulatory obligations.




Please note that in some countries, consent is the basis on which Personal Data is processed.


Who has access to 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 Novartis Group companies;
  • our partners, e.g. other pharmaceutical and medical device companies, in the context of consortia or industry initiatives;
  • suppliers and services providers acting on behalf of Novartis 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, in order to comply with local laws, regulations or pharmaceutical industry codes applicable to Novartis. 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.  


Where is Personal Data stored?


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 (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 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 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. Read more about the Novartis Binding Corporate Rules at novartis.com/privacy


How long do we store Personal Data?


We will keep your Personal Data as long as needed for legal and regulatory requirements. Please note that in certain countries we may be required to retain Clinical Study Documentation for a minimum of 25 years.  


What are your rights and how can you exercise them?


You have the 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;
  • request the erasure of your personal data or the restriction of its use;
  • if the processing is based on your consent, to withdraw your consent at any time, without affecting the lawfulness of the processing before such withdrawal;
  • object, in whole or in part, to the processing of your personal data; and
  • 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 click here.

In any case, you also have the right to file a complaint with a supervisory authority in addition to your rights above.


How can you contact us?


If you want to contact our Data Protection Officer, please email [email protected] or write to Global Data Privacy Office, Novartis Pharma AG, Lichtstrasse 35, 4056 Basel, Switzerland.

This Privacy Notice was last updated in August 2022. Changes or additions will be notified through our usual communication channels (e.g. via novartis.com/privacy).


Footnotes


¹Clinical investigators: principal investigator, sub-investigator or co-investigator who are directly involved in the treatment or evaluation of research subjects in NOVARTIS Clinical Studies 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.

This Privacy Notice was last updated in March 2022. Changes or additions will be notified through our usual communication channels (e.g. via our website).