SPONSOR’S PRIVACY NOTICE FOR PRINCIPAL INVESTIGATOR AND STUDY PERSONNEL

 

Dated: 7 October 2019

Shionogi B.V. (“Shionogi”) is the European headquarters of Shionogi & Co., Ltd., a 140 year old global research-driven pharmaceutical company, headquartered in Osaka, Japan.

The laws and regulations governing clinical trials require Sponsors to collect, use and retain certain personal information about individuals who are involved in the conduct of its clinical trials (including principal investigators, sub-investigators, and study personnel).

Shionogi is the data controller of your personal information that is collected in connection with the clinical trials it sponsors, and is responsible for looking after it and using it properly. Shionogi is required by applicable data protection laws to provide you with certain information about how and why we collect, use, hold and protect your personal information. Full details, including details of your rights in respect of your personal data, are set out in our Privacy Policy on our website at http://shionogi.eu/pages/privacy-policy.  The key points are summarised below.

 

Name of data controller

Shionogi B.V.

Our contact details

 

Registered office: Kingsfordweg 151, 1043GR, Amsterdam, Netherlands

Correspondence address: 33 Kingsway, London, WC2B 6UF

Email: dataprotectionlead@shionogi.eu

Phone: +44 (0)20 3053 4200

Website: http://www.shionogi.eu

Categories of personal data we collect about you

 

1.      General categories of personal data

Identity and contact data: such as full name, business and personal address, phone numbers, email address.

Professional data: such as workplace and address, position, medical specialty, professional qualifications and experience, medical license, training, publications, awards, affiliations, other information included in your CV.

Financial data: where applicable, information needed for payment processing (e.g. bank account details), and details of any significant financial relationship with Shionogi.

Interaction data: such as your participation in our training sessions, details of our meetings/calls, details of our agreements with you.

2.      Special categories of personal data

Shionogi does not collect special category data about you (i.e. about racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, health, sex life or sexual orientation, genetic and biometric data) unless it is required or permitted to do so by applicable law, or you provided your explicit consent.

Sources of personal data

Directly from you; from the Institution conducting the clinical trial; from the Principal Investigator; from the Sponsor’s contract research organization (CRO).

Purposes for processing your personal data

Your personal data will become part of the clinical trial databases and clinical trial master file and Shionogi (and its chosen contract research organization acting on its behalf) will process your personal data for the purposes of:

·           assessing your suitability to participate in the conduct of the abovenamed clinical trial or other clinical trials, either as Principal Investigator or a member of the study personnel.

·           communicating with you about this clinical trial or other clinical trials.

·           managing the conduct of the clinical trial and your participation.

·           to carry out other clinical trial activities as required or permitted by laws, regulations and/or guidelines governing clinical trials (including responding to adverse events, drug safety concerns and complaints, medical information enquiries, and performing monitoring visits, inspections and audits of the clinical trial at the investigative site at which you work).

·           communicating and corresponding with regulatory bodies relating to the clinical trial and preparing and submitting regulatory filings.

·           publicly disclosing payments or benefits in kind (i.e. transfers of value) made to you in connection with the clinical trial and/or our agreement with you, in accordance with applicable law and pharmaceutical industry codes.

·           complying with requests from regulators, courts, law enforcement authorities, government investigators, or in connection with litigation.

The processing may be performed both electronically and in hard copies.

Automated decisions

None.

Who we may share your personal data with

We may share your personal data with:

·           Shionogi group companies in other parts of the world (including Japan, the US, the UK and the Netherlands).

·           third party service providers, including the clinical research organization appointed by Shionogi to carry out certain tasks relating to the clinical trial.

·           professional advisors such as lawyers, insurers, auditors.

·           regulatory bodies (including those responsible for regulating pharmaceutical industry codes), data protection supervisory authorities, law enforcement bodies, government authorities, courts, tribunals, arbitrators.

·           third parties (including other Shionogi group companies) in relation to the sale or reorganisation of our business.

·           any other person with your consent.

Legal basis for processing your personal data

The legal basis for the collection and processing of your personal data is:

·           processing is necessary for us to perform our obligations under a contract between us and you, or us and the investigative site that employs you.

·           processing is necessary to comply with Shionogi’s legal obligations.

·           processing is necessary for Shionogi’s legitimate interests (which are to carry out and evaluate clinical trials to understand conditions and develop medicines, to ensure safety of its products, to inform decisions from regulatory authorities on access and reimbursement of new treatments for the benefit of patients, and to advance scientific research and medical discovery) and these interests do not prejudice or harm your rights and freedoms.

·           processing is necessary for the performance of a task carried out in the public interest.

·           processing is necessary to protect the vital interests of an individual.

·           you have given your consent or explicit consent.

Your right to withdraw consent

Where you have given your consent to any processing of your personal data, you can withdraw it at any time by contacting Shionogi’s Data Protection Lead at dataprotectionlead@shionogi.eu.  If you do, it will not affect the lawfulness of any processing for which we had consent prior to your withdrawing it.

Direct marketing

Shionogi will not use your personal data for direct marketing purposes.

Location of your personal data

Shionogi has group companies, vendors and partners located in different countries, including Japan, the US, the UK and the Netherlands. For the purposes set out above, your personal data may be held in any of these locations or any other location. If we transfer your personal data to our Shionogi group companies, vendors or partners outside the EEA for the purposes above, we will take appropriate measures to protect it and comply with law (including requiring that the international recipient signs a special contract to provide legal protection for your data, known as the European Commission’s Standard Contractual Clauses).

How long we will keep your personal data

Your personal data will become part of the clinical trial master file, which will be retained until the later of (i) the retention period required by applicable law; or (ii) the period required by the Protocol, which may be for a period of up to 25 years after the completion of the clinical trial. The retention period may be extended if Shionogi is required to preserve your personal data in connection with litigation, investigations and proceedings, or if longer retention periods are required by law.  

Your rights in respect of your personal data

You have the right to access your personal data and, in some cases, to require us to restrict, erase or rectify it or to object to our processing it, and the right of data portability. To exercise your rights, see the “How to contact us” section below.

Complaints and How to Contact Us

 

If you are concerned about how we are handling your personal data, have questions, or want to exercise your privacy rights, please email our Data Protection Lead at dataprotectionlead@shionogi.eu in the first instance. 

You can also make a complaint to the Information Commissioner’s Office at www.ico.org.uk.