GCT1021-01 – Trial of Enapotamab Vedotin (HuMax®-AXL-ADC)
For the Genmab clinical trial; “First-in-human, open label, dose-escalation trial with expansion cohorts to evaluate safety of Axl-specific antibody-drug conjugate (HuMax®-AXL-ADC) in patients with solid tumors – Protocol GCT1021-01 (as further described in the Subject Information and Informed Consent Form provided to you as trial participant)
1) DATA CONTROLLER
The entity responsible for the processing of your personal data is:
Genmab A/S (CVR no. 21023884)
Kalvebod Brygge 43,
DK-1560 Copenhagen V
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: [email protected]. 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.
2) USE OF PERSONAL DATA
We may use your personal data for the following purposes:
The purpose of collecting and using your personal data is to investigate the safety and efficacy (how well the drug works) and how well enapotamab vedotin (HuMax®-AXL-ADC) is tolerated in subjects with different solid tumors. The results of this trial may be used in an application to the relevant regulatory authority for the approval for sale of enapotamab vedotin (HuMax®-AXL-ADC). More information on the purpose of the trial is provided in the Subject Information Form under the section “WHAT IS THE BACKGROUND TO AND PURPOSE OF THE TRIAL?”.
3) CATEGORIES OF PERSONAL DATA
We may collect the following categories of personal data about you:
- Ordinary personal data: your sex, date of birth, body weight and height
- Special categories of data:
- Your race and ethnicity
- Your medical data including your medical history, CT/MRI/PET-CT scans and clinical measurements, ECGs, blood samples, biopsies and, if you have provided additional consent (in the Subject Information Form), genetic data, your health status and information about your use of the trial medicine, the effect it has on you and its potential side effects
Please note your personal data will be documented in pseudonymous form. This means that that your name will not be associated with your personal data – only your unique trial participant number will be associated with it.
To the extent permitted by the applicable laws and/or regulations, We will take all reasonable measures to protect the confidentiality of your personal data and your identity. Your personal data and your identity will never be made publicly available.
Your name, contact details and Social Security number (if applicable) will only be collected by the Investigator and stored in the Investigator’s site file and will never be transferred to Us or any third parties.
We collect information, the above-referenced personal data, about you from the Investigator as part of the clinical trial.
5) LEGAL BASIS
We may process your personal data described above based on the following legal basis:
Art. 9 (2) litra (i) of the Regulation (EU) 2016/679 of April 27, 2016 (the General Data Protection Regulation, hereinafter referred to as the “GDPR”); We have a legitimate purpose in collecting and using your personal data for scientific research purposes as described above. The processing of your personal data is necessary in order for us to comply with legal obligations including notifications to the regulatory authorities to for example ensure your safety.
6) SHARING OF YOUR PERSONAL DATA
To verify that the trial is being conducted correctly and to analyze the personal data collected during this trial, We, our authorized representatives, laboratories, research institutions, the contract research organization Theradex, data management services and IT system suppliers, auditors and authorized employees of the regulatory authorities of your country of residence, The Food and Drug Administration (FDA), and from other countries will be allowed to inspect your personal data held by the Investigator. The authorities will verify that the trial is being conducted correctly, in particular that data are being correctly collected and documented. All third parties are obligated to observe the rules of professional confidentiality and will only use your personal data as described in the Subject Information and Informed Consent Form. They are only permitted to process your personal data in a pseudonymous form and are not allowed to prepare photocopies or written copies of your medical records, unless allowed by law. We may also share your personal data with third parties to the extent required by law, for example if We are obligated to disclose your personal data in order to comply with any legal obligation or to establish, exercise or defend Our legal rights.
Your general practitioner may be informed of your participation in this trial.
7) TRANSFERS TO COUNTRIES OUTSIDE THE EU/EEA (applicable if you are an EU trial participant)
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 through the following means:
U.S.: EU Standard Contractual Clauses
8) RETENTION OF YOUR PERSONAL INFORMATION
Your personal data will be saved by Us 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. We shall archive the content from the clinical trial master file for at least 25 years after the end of the clinical trial. However, your medical files at the site will be archived in accordance with national law.
9) YOUR RIGHTS
You have a number of legal rights in relation to the personal data that We hold about you. These rights include:
- You are entitled to ask for up-to-date information on which personal data have been recorded, how the personal data has been recorded, to see personal data relating to you and to have personal data relating to you corrected if it is inaccurate.
- Your participation in the trial is voluntary. Your choice will not affect your present or future treatment.
- In some circumstances, the right to receive the personal data collected about you in a structured, commonly used and machine-readable format and/or the right to request that We provide those data to a third party where this is technically feasible.
- The right to strict confidentiality when your personal data is used/processed.
- The right to request that We erase your personal data in certain circumstances.
- The right to request that the processing of your personal data is restricted in certain circumstances.
- The right to lodge a complaint with the data protection regulator if you think that any of your rights have been violated.
Please note there may be conditions or limitations on these rights. It is therefore not certain, for example, that you have the right to restricted use of your personal data in a specific case as We need to manage your information in specific ways in order for the research to be reliable and accurate.
Last updated: February 2019