星海棋牌

The entity responsible for the processing of your personal data is:

星海棋牌 (CVR no. 21023884)

Carl Jacobsens Vej 30,

DK-2500 Valby

Please note, We recommend that you liaise with the Investigator or researchers if you have any questions to the processing of your personal data. The Investigator or researchers will direct your requests as needed by using your study subject ID to Us. It is recommended to use this approach as this will ensure that your request will be dealt with in the most confidential way and your identity does not need to be revealed to Us. If you feel that the Investigator or researchers are unable to address any question you have about the processing of your personal data and your rights, you can contact our Data Protection Officer at: privacy@genmab.com. You also have the right to lodge a complaint with the data protection regulator if you think that any of your rights have been violated.

As mentioned in the Participant Information Sheet and Consent Form, your personal data will be disclosed to the sponsor鈥檚 parent company 星海棋牌. 星海棋牌 will take all reasonable steps to keep your personal data and identity confidential. Your personal data and your identity will never be made public.

星海棋牌 will ensure that your personal data is handled according to the Danish law and the European Union data protection law. The following explains:

星海棋牌 will collect and store the following personal data about you:

Only the study doctor will collect your name, contact details, and Medicare number (if applicable). The information will be stored in the clinic and will never be sent to 星海棋牌 or any third parties.

The purpose of collecting and processing your personal data is to establish the safety and tolerability of epcoritamab in patients with refractory chronic lymphocytic leukemia (CLL) or Richter麓s syndrome (RS). The results of this research project may be used to apply for a license to market epcoritamab. You can read more about the purpose of the trial in this Participant Information Sheet and Consent Form under the section 鈥淲hat is the purpose of this research?鈥�

The processing of your personal data is needed in order for 星海棋牌 to comply with legal obligations. These obligations include notifications to the regulatory authorities and archiving, for example to ensure your safety. The legal basis for such processing of your personal data is described in art. 6 (1) (c) and art. 9 (2) (i) of 鈥淕DPR.鈥澛� Further, 星海棋牌 has a legitimate purpose in collecting and using your personal data for scientific research purposes. The legal basis for such processing of your personal data is described in art. 6 (1) (f) and art. 9 (2) (j) of the GDPR.虏

You should notify the study doctor <insert name of trial doctor> or study staff at <insert phone no.> if you withdraw from the research project. Your personal data already collected will still be used. After your withdrawal, no new personal data will be collected or processed for the research project unless it relates to an already reported side effect. Your medical record may be examined if a side effect occurs.

星海棋牌 may share your personal data with other companies and organizations subject to confidentiality. This includes 星海棋牌鈥檚 collaboration partner Abbvie Deutschland GmbH & Co and other companies within the AbbVie group, and the following categories of data processors: contract research organizations, such as IQVIA, laboratories, and IT suppliers. Such companies and organizations work for or with 星海棋牌 to develop epcoritamab and may only use your personal data for the purposes described in the Subject Information and Informed Consent Form and will only receive your personal data in a coded form.

星海棋牌鈥檚 authorized representatives, such as auditors and monitors may review your personal data including your medical record to verify that the research project is being run correctly. 星海棋牌鈥檚 Genomic Data Review Committee will review the genomic data generated throughout the research project. In some situations, it may be required to access data remotely where it is not feasible for auditors and monitors to travel to or access the study center in person to verify the data. By signing the informed consent form, you accept such remote access if allowed by local regulations. In addition, members of the Independent Ethics Committee and representatives of the regulatory authorities from your country of residence or from other countries may review your personal data including your medical record to verify that the trial is being run according to the protocol and your rights and safety are protected. 星海棋牌 may also share your personal data with third parties if required by law. An example would be if 星海棋牌 must disclose your personal data to comply with any legal obligation or to establish, exercise or defend 星海棋牌鈥檚 legal rights.

Information about this trial can be found on public websites around the world. This corresponds with 星海棋牌鈥檚 commitment for transparency of our clinical research and with applicable laws and regulations. A description of this clinical trial will be available on , as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Your personal data may be transferred within the EEA or to countries outside the EEA, that 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 GDPR art. 49 (1) through EU Standard Contractual Clauses.

When transferring your personal data to vendors in the United States, we 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. 

星海棋牌 will save your personal data in accordance with the regulation (EU) 2014/536 of 16 April 2014 (on clinical trials on medicinal products for human use) unless other EU law requires archiving for a longer period. 星海棋牌 will archive the content from the clinical trial master file for at least for the product lifetime plus 25 years after the end of the clinical trial. 

You have a number of legal rights in relation to the personal data that 星海棋牌 holds about you. These rights include:

Please note there may be conditions or limitations on these rights. You may for example not have the right to restricted use of your personal data if 星海棋牌 needs to manage your information in specific ways in order for the research to be reliable and accurate.

If you have any questions about this information, please contact your study doctor via the information given in the Participant Information Sheet and Consent Form. The study doctor will direct your requests as needed by using your trial patient ID to 星海棋牌. This approach is recommended to ensure that your request will be dealt with in the most confidential way as your identity does not need to be revealed to sponsor or 星海棋牌.

You can always contact 星海棋牌鈥檚 Data Protection Officer at: privacy@genmab.com 星海棋牌, (CVR no. 21023884); Kalvebod Brygge 43; DK-1560 Copenhagen V; Denmark; www.genmab.com if you feel that the study doctor is unable to address any question you have about 星海棋牌 processing of your personal data and your rights, or if you want to file a complaint regarding 星海棋牌鈥檚 processing of your personal data. You also have the right to lodge a complaint with the data protection regulator if you think that any of your rights have been violated.