Privacy

Study site located in Europe


This Privacy Notice explains how 星海棋牌 ("We", "Us") process your personal data when you are the Principal Investigator or are otherwise involved as site staff in the performance of a clinical trial sponsored by 星海棋牌.

1)  DATA CONTROLLER

The entity responsible for the processing of your personal data is:
星海棋牌 (CVR no. 21023884)
Carl Jacobsens Vej 30,
2500 Valby, Denmark
 
Contact details (if you have inquiries and/or questions to our processing of your personal data):
 
2)  USE OF PERSONAL DATA

Your personal data may become part of the clinical trial database and paper files as needed for the implementation, performance, and record-keeping (archiving) of the clinical trial, in particular, your personal data may be processed to: 
 
a.   manage your involvement in the clinical trial and the participation of the investigative site;
b.   communicate with you and the investigative site in connection with the clinical trial; and
c.   support applications for approval of the product under investigation. 

Providing your personal data is necessary to take part in any clinical trial activities for 星海棋牌.
 
3)  CATEGORIES OF PERSONAL DATA

We may collect the following categories of ordinary personal data about you:
  • name, business contact details
  • information related to your professional qualifications and experience
  • your participation and role in the clinical trial activities; if you are an investigator or a sub-investigator, any significant financial relationship with Us as the sponsor
  • information needed for payment processing (where payments are made directly to you)

We do not process any special categories of personal data (sensitive personal data) about you.
 
4)  LEGAL BASIS

We may process your personal data described above based on the following legal bases:
  • GDPR鹿 art. 6 (b) the processing is necessary for the performance of the contract between you and Us, for example, when processing your personal data for payments.
  • GDPR art. 6 (c) the processing is necessary for compliance with legal obligations to which We are subject. These legal obligations include notifications to the regulatory authorities and archiving for documentation purposes.
 
 
5)  SHARING OF YOUR PERSONAL DATA

We may share your personal data with other companies within the 星海棋牌 group, our service providers, contractors, government agencies, researchers and with research institutions who will use your personal data only for the purposes described above; including relevant regulatory authorities if requested or if part of a submission.
 
6)  TRANSFERS OF EU PERSONAL DATA TO COUNTRIES OUTSIDE THE EU/EEA

Your personal data may be transferred within the EEA or to countries outside the EEA, which are not deemed to provide an adequate level of protection of your personal data compared to the EEA. Instead, we have provided appropriate safeguards as required by the GDPR Art. 46 (2) (c) through EU Standard Contractual Clauses (if applicable) and we follow the recommendations from the EDPB (European Data Protection Board) for transferring EU data to third countries.

When transferring your personal data to vendors in the United States, we may rely on their self-certification to the EU-US Data Privacy Framework () or, when this is not the case, on EU Standard Contractual Clauses.

You may obtain a copy of the EU Standard Contractual Clauses by contacting us at privacy@genmab.com.

Please note your personal data may be shared with regulatory authorities outside the EU as part of a submission for approval of the investigational product.
 
7)  RETENTION OF YOUR PERSONAL INFORMATION

Your personal data will be stored for as long as required under applicable laws, rules and/or regulations, which may be for a period of 25 years after the completion of the clinical trial. The retention period may be extended if We are required to preserve your personal data in connection with litigation, investigations or other relevant proceedings.
 
8)   YOUR RIGHTS according to the GDPR

In general, you have the following rights:
  • You have the right to request access to and rectification of your personal data.
  • You also have the right to object to the processing of your personal data and have the processing of your personal data restricted.
  • You have the right to receive your personal data in a structured, commonly used and machine-readable format (data portability).
  • You may always lodge a complaint with a data protection supervisory authority, e.g. The Danish Data Protection Agency (Datatilsynet)

If you would like to exercise any of these rights, please contact us at privacy@genmab.com.
 
There may be conditions or limitations on these rights. It is therefore not certain for example you have the right of data portability in the specific case - this depends on the specific circumstances of the processing activity.


[1] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April, 2016 (鈥淕DPR鈥)



Last updated: September 2024