“The purpose of this Privacy Notice is to inform you, as a member of the investigative study team at your clinical research site how we collect and use your personal data in relation to your involvement in studies related to COVID-19 and managed by contract research organization Worldwide Clinical Trials (“Worldwide”). This Privacy Notice also gives you information concerning your rights relating to your personal data processed by Worldwide.”
What personal data is collected?
The following of your personal data will be collected by or on behalf of Sponsor or Worldwide
During the Feasibility Assessments:
In case your site is selected participating the study the following personal data will also be collected:
How is your personal data used?
The Sponsor of the Study, who is a Data Controller of the personal data described above, either itself or through a service provider (including Worldwide), will collect, process, store and use your personal data for the following purposes:
a) to perform the clinical trial contract, administer the Study, clinical monitoring and auditing, and maintenance of the Trial Master File;
b) to comply with legal regulations for the Study and for the use of the results, such as applying for product registration; and
c) to review and assess your historical and current involvement in clinical trials and to contact you regarding participation in future studies.
Worldwide is a Data Controller of the personal data described above for the following limited purposes, and will collect, process, store and use the personal data only for the following purposes:
a) To review and assess your historical and current involvement in clinical trials and inviting you regarding participation in future studies.
To whom could the personal data be disclosed?
In connection with the above purposes, Sponsor and Worldwide may disclose the personal data to the following categories of recipients:
a) competent authorities (including in the context of product registration);
b) third parties who process the personal data on behalf of Sponsor (including Worldwide)
c) Sponsor, its affiliates and partners in development who are involved in the Study or in subsequent activities where the results are used, such as applying for product registration;
d) third parties who process the personal data on behalf of Worldwide; or
e) Worldwide affiliates.
In rare cases your personal data may be used in connection with investigations or legal proceedings, in which case your personal data may be disclosed to law enforcement agencies or other governmental authorities. Your personal data may also be shared with the Sponsor or Worldwide’s advisors in such matters.
In connection with any of the above purposes, your personal data may be transmitted to countries outside the European Union which are not regarded as providing an adequate level of protection for personal data. Your personal data shall only be transferred where appropriate safeguards are in place to protect your personal data. More information regarding such safeguards may be obtained from Worldwide’s Data Protection Officer.
The Sponsor and Worldwide or their affiliated companies have agreements in place with the service providers who may have access to your personal data as described above, under which they are bound to keep the information confidential and not to use it for any other reason other than for the purposes described in this notice. The Sponsor’s and Worldwide’s advisors are bound by obligations of professional secrecy.
Legal Basis for Processing
The legal basis for the collection and use of your personal data is:
Legitimate Interests: We have legitimate interests to process your personal data for scientific research purposes.
Legal obligation: the processing is necessary to comply with applicable laws and regulations.
Personal Data Retention:
We will only retain your personal information for as long as necessary to fulfil the purposes we collected it for. To determine the appropriate retention period for personal data, we consider the amount, nature, and sensitivity of the personal data, the potential risk of harm from unauthorized use or disclosure of your personal data, the purposes for which we process your personal data and whether we can achieve those purposes through other means, and the applicable legal requirements.
Sponsor and Worldwide have put in place appropriate security measures to prevent your personal information from being accidentally lost, used or accessed in an unauthorized way, altered or disclosed in accordance with our respective information security policies and procedures. Sponsor and Worldwide have put in place procedures to deal with any suspected data security breach and will notify you and any applicable regulator of a suspected breach as required by applicable law.
What are your rights to personal data?
You are entitled at any time to access your personal data and/or, to the extent legally permissible, to have such information deleted or corrected or transferred or to object to the processing of the personal data or to request the restriction of the processing of the personal data. However, we may continue processing your personal data where it is necessary to comply with the law, or where further processing of your personal data is required for our legitimate interests for scientific research purposes and your interests and fundamental rights do not override those interests.
Your rights can be exercised by notifying Sponsor or Worldwide data protections teams. You are also entitled to lodge a complaint with their local supervisory authority. You may contact Worldwide data protection team at the following:
Worldwide Clinical Trials
1st Floor, Waterfront House, Beeston Business Park,
Beeston, Nottingham, NG9 1LA, UK
Attn: Data Privacy Representative
or via email to Worldwide’s Data Protection Officer at firstname.lastname@example.org.