InflaRx GmbH (Winzerlaer Str. 2, 07745 Jena, Germany), as the sponsor of the PG-study IFX-1-P3-4, is responsible for processing the data collected from you via the questionnaire.
Questionnaire-data
All data you provide in the questionnaire will only be used to determine whether you are eligible to participate in the clinical trial on the efficacy and safety of vilobelimab (IFX-1) in the treatment of ulcerative pyoderma gangrenosum.
If you are eligible as a participant and have given your consent, we will also use the data to establish contact with the study center you have selected to conduct the clinical trial. For this purpose, we will send your contact details and the questionnaire to the study center. The data processing is based on your consent, Art. 6 para. 1 sentence 1 lit. a GDPR, Art. 9 para. 2 sentence 1 lit. a GDPR. You can withdraw your consent at any time with effect for the future. The withdrawal does not affect the lawfulness of processing the data in the past.
If the sponsor receives access to your data, it will only be made available to them in pseudonymized form. Pseudonymized means that no information with which you can be directly identified (e.g. name, contact information, date of birth, etc.) is used, but only a number and/or letter code.
Please note: The data you provide does not constitute consent to participate in the clinical trial, but will only be used to determine your eligibility to participate in the trial. If necessary, additional data may be required at a later stage to check your participation in the study.
E-Mail address
To ensure that the address provided is correct and that we can communicate with you via this address as part of the selection process, we will verify the e-mail address accordingly. For this purpose, we will send a confirmation link to the address provided. By clicking on the link you confirm this, following which you can continue with the completion of the questionnaire.
Data processing is carried out on the basis of Art. 6 para. 1 sentence 1 lit. f GDPR. We have a legitimate interest in ensuring that the e-mail address provided is correct and that we can communicate with you via the e-mail address provided as part of the recruitment process.
We are supported in the recruitment of eligible study participants by our service provider Semantic Hub SA (Avenue d'Ouchy 4, 1006 Lausanne, Switzerland). This is a processor that processes your data exclusively in accordance with your instructions and is contractually bound accordingly. From the perspective of the GDPR, the adequate level of data protection in Switzerland is guaranteed by the adequacy decision according to Art. 45 GDPR (available here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32000D0518).
If you have given your consent, the study site you have chosen will receive the data you have provided.
If you are not eligible as a potential study participant, after evaluation of the questionnaire, your data will be deleted immediately.
If you are eligible as a potential study participant after evaluation of the questionnaire, your data will be stored until the decision is made, whether or not you are participating in the clinical study, but in any case not longer than six months.
In accordance with the legal regulations, you have the right to access your personal data from the controller (Art. 15 GDPR) and, in certain cases, the right to rectification (Art. 16 GDPR) or erasure (Art. 17 GDPR) or to restriction of processing (Art. 18 GDPR) as well as the right to data portability (Art. 20 GDPR). If data is processed on the basis of Art. 6 para. 1 sentence 1 lit. f GDPR (data processing to safeguard legitimate interests), you have the right to object to the processing at any time for reasons arising from your particular situation (Art. 21 GDPR). We will then no longer process the personal data unless there are demonstrably compelling legitimate grounds for the processing which override your interests, rights and freedoms, or the processing serves the establishment, exercise or defense of legal claims. Please address your objection to the sender of the letter.
You also have the right to lodge a complaint with a supervisory authority if you believe that the processing of data concerning you violates data protection regulations. The right to lodge a complaint may be exercised in particular with a supervisory authority in the Member State of the data subject's habitual residence or place of the suspected infringement.
To assert your rights, please contact our service provider Semantic Hub at patientsupport@semantic-hub.com. Semantic Hub has been entrusted by the controller, InflaRx GmbH, with the processing of your data subject requests and will process your requests in accordance with the instructions of InflaRx GmbH.
We are also supported by our data protection officer in the fulfillment of our data protection obligations. The contact details of our data protection officer are:
datenschutz süd GmbH
Wörthstraße 15
97082 Würzburg
Germany
E-Mail: office@datenschutz-sued.de
Telephone: +49 (0) 931 30 49 76-0