Subject Information & Consent Form Prescreening for the Gastroparesis Trial
What should I know about this survey?
Taking part in this research is voluntary. Whether you take part is up to you.
You can choose not to take part. There will be no penalty or loss of benefits to which you are otherwise entitled.
You can agree to take part and later change your mind. There will be no penalty or loss of benefits to which you are otherwise entitled.
What is the aim of this survey?
The objective of this survey is to find out if you are eligible for a clinical trial in diabetic or idiopathic gastroparesis. If you pass the pre-screening survey and are eligible, your personal information will be forwarded to a close-by research site. A study coordinator/nurse or study doctor will contact you to arrange an in-person screening to do further testing to check if you are eligible for study participation at site.
What is expected from me to complete the survey and how long will it last?
This survey includes a screening questionnaire of five questions. The questionnaire asks about general questions on medical profile. If eligible, you will be contacted by a study site near you to start your participation in the clinical trial or you can use the site finder function to get in contact with the site on your own.
The time to answer the screening questionnaire is estimated to 5 minutes.
What happens with your data?
The Personal Data collected through this survey in order to organize your participation to the clinical trial will be transmitted to DynamIQ Health GmbH.
Personal Data will also be shared with participating research sites, to get in contact with you, if you pass the pre-screening survey.
The other Personal Data will be used to conduct this survey, conduct the analysis, reporting and regulatory submission, as the case may be, meet the above-mentioned goals of the survey, as well as for statistical purposes. We will not use your Personal Data for other purposes.
The study results without personal data information will be transmitted to ProInnovera GmbH, the CRO conducting the clinical trial and Dr. Falk Pharma GmbH, a pharmaceutical company committed to the care and improvement of the quality of life of people suffering from gastroparesis. The results will also be shared with the Institutional Review Board (IRB) that reviewed this research.
The analyzed results can be subject to scientific publications or communications during scientific congresses.
Your personal data is stored by DynamiQ Health until the final decision is made if you are enrolled or not enrolled in the study. If you are enrolled we keep your data until you finished the study, if you are not enrolled your personal data will remain archived for the period of 3 months before being completely deleted.
What rights do you have regarding your data?
Right to information
In accordance with Art. 15 DSGVO, you have the right to receive information about the data stored about you. We will gladly comply with your request for information. Please address your request for information in writing to our data protection officer. (see below for contact details)
Should you exercise your right to information, we will store your request and the response to it in order to meet our accountability obligations.
The legal basis for the processing of your data in the case of a data subject rights request is based on Art. 5 para. 2 DSGVO in conjunction with. Art. 6 para. 1 p. 1 lit. f) GDPR. Your request for information and our response will be kept for a period of 3 years.
Correction, deletion, right to restriction
If incorrect personal data has been processed, you have a right of rectification pursuant to Art. 16 DSGVO.
If the legal requirements are met, you can request the deletion or restriction of processing, as well as object to data processing (Art. 17, 18 and 21 DSGVO).
We will gladly comply with your request for correction, deletion and restriction. Please direct your request in writing to our data protection officer. (contact details see above)
If you exercise your rights of rectification, erasure and restriction, we will retain your request and the response to it in order to meet our accountability obligations.
The legal basis for the processing of your data in the case of a data subject rights request is based on Art. 5 para. 2 DSGVO in conjunction with. Art. 6 para. 1 p. 1 lit. f) GDPR. The retention of your data subject rights request and our response will be for a period of 3 years.
Right of objection
You have the right, on grounds relating to your particular situation, to object at any time to the processing of personal data concerning you which is carried out on the basis of Art. 6 para. 1 p. 1 letter f) DSGVO (legitimate interest). [This also applies to profiling based on this provision within the meaning of Art. 4 No. 4 DSGVO, which DynamiQ Health GmbH uses for credit rating or advertising purposes]. If you object, DynamiQ Health GmbH will no longer process your personal data, unless DynamiQ Health GmbH can demonstrate compelling legitimate grounds for the processing which override your interests, rights and freedoms, or the processing serves the assertion, exercise or defense of legal claims.
The objection can be made form-free and should preferably be addressed to:
DynamiQ Health GmbH
Wienburgstrasse 207
48159 Münster
Germany
Tel.: 0251 59063570
E-mail: privacy@dynamiq-health.com
An advertising objection can also be made via a link in the newsletter, if applicable.
Within what framework are your data collected?
Your participation is voluntary. The treatment of your health data is conducted based on your explicit consent, which is formalized by the click on the “Start” button on the survey’s introduction page. You may withdraw your consent at any time without providing a reason, without affecting the lawfulness of the processing carried out prior to the withdrawal of your consent.
Who is responsible for the treatment of my data?
DynamIQ Health GmbH will process your personal data. The data controller may be contacted at the following email address:
What happens if I agree to be in the survey, but I change my mind later?
Your participation in this online pre-screening survey is voluntary and you may withdraw consent for data collection at any time.
If you withdraw consent for the use of your data, the data controller will not keep record or use any data collected before the withdrawal.
Will I be paid for taking part in this online survey?
You will not be paid for completing the survey.
