Dataprotection

Information for study participants in studies sponsored by ABCSG/ABCSG GmbH

Dear Study Participant,

The data protection legislation of the European Union has been updated with the introduction of the General Data Protection Regulation (GDPR, effective as of May 25, 2018). Both, ABCSG – Verein zur Prävention und Therapie bösartiger Erkrankungen, Austrian Breast and Colorectal Cancer Study Group (“ABCSG”) and ABCSG GmbH perform studies and serve as sponsors according to applicable law (in Austria: Arzneimittelgesetz).

For this reason ABCSG / ABCSG GmbH (“Sponsor”) would like to inform you about the following:

As already explained in the patient Information and informed consent, ABCSG GmbH has the right, through its study monitors and auditors at the study site, to access your personal data which has been collected at the study site in order to verify the quality of the data transfer in the study. Within the scope of this access and quality check (data processing), ABCSG GmbH is responsible for your personal data and is therefore controller within the meaning of the GDPR.
As the personal data collected in the course of this study can be retained for a period of 15 years or longer, data processing by ABCSG GmbH is also possible for these periods. For more information about how ABCSG GmbH handles the access of your personal data by its study monitors and auditors, you will find more information below.
The use of your personal data by ABCSG GmbH for the purposes described in the patient information and informed consent is based on your consent and on legal requirements covering the conduct of clinical trials.
If you have consented to your personal data being used for other scientific purposes in addition to the study, you have the right to object to that use. If you wish to object to such use, please contact your investigator.
If we send your data to another country, it will only be done in a form that does not allow tracing back your identity. Personal data can only be transferred to a country outside the EU/EEA if the transfer is covered by a contract which has been approved by the respective Data Protection Authority (DPA).
You can ask the investigator to have access to the personal data that has been collected about you. If you believe that any of these data are incorrect, you may ask your investigator in writing if they can be rectified or erased. You may also request that the use of your personal information be restricted.
If you change your mind about participating in the study, no further personal data of you will be collected. However, your personal data that has been collected up until consent withdrawal will still be used.
If you have any questions about how your personal data will be used in the study, please first contact your investigator.
You have the right of access to your collected personal data according to Art. 15 GDPR, the right to rectification of inaccurate personal data concerning you according to Art. 16 GDPR, the right to erasure of your personal data according to Art. 17 GDPR, the right to restriction of processing of personal data according to Art. 18 GDPR, the right to object to processing of personal data according to Art. 21 GDPR as well as the right to data portability according to Art. 20 GDPR, if the ABCSG GmbH is responsible for and controls the processing.

There will be no automated decision making, including profiling; therefore, no automated processing of your data is undertaken for the purpose of analyzing or predicting certain personal aspects of you, such as health, personal preferences, behavior. If personal data is processed for a purpose other than the one for which the personal data was collected, we will inform you of such other purpose if such processing is not covered by applicable law.

You can also contact the privacy officer of ABCSG GmbH directly: Chief Privacy Officer, ABCSG/ABCSG GmbH, Nussdorfer Platz 8, 1190 Vienna, privacy@abcsg.at.

If you are not satisfied with the answers you receive, you can also lodge a complaint with a supervisory authority according to GDPR, eg in Austria with the Austrian Data Protection Authority, Österreichische Datenschutzbehörde, Barichgasse 40-42, 1030 Wien, Telefon: +43 1 52 152-0, E-Mail: dsb@dsb.gv.at.

Learn more about how the sponsor handles access of your personal data through its study monitors and auditors

What is personal data in a study?

Your study doctor will collect your personal data according to a specific study protocol, i.e. your name, initials, address, gender, age / date of birth, information about your health, your response to the study drug, any side effects you may have, blood tests, scans, physical examinations, or other procedures; demographic data, lifestyle information and genetic information and imaging methods (if applicable).

Your study doctor will replace your name and other information about yourself with a code, usually a number. Only your age at randomization / your year of birth / date of birth (the latter only for participants in studies that began before May 20, 2018) and your gender remain uncoded. The data encrypted in this way are classified as pseudonymised = encrypted personal data in terms of data protection law. The information to break down the code remains at the study center and will not be shared with the sponsor. The sponsor will only receive the following personal data from your study doctor for the purposes of the study:

the code assigned to you (without breakdown) and age / year of birth / date of birth (the latter only for participants in studies that started before 20 May 2018), gender
Study Information

How is personal data processed?

Your personal data will be used to verify that the study has been or will be conducted properly and whether the study medication is safe and effective. Your encrypted personal data will be examined together with the encrypted personal data of all other participants in the study to learn more about the effect of the medicine.

Part of the processing of your data can be automated, the sponsor can therefore use computers and other technologies to process your data.

Where is personal data stored and kept secure?

The encrypted personal data collected in a study is entered into Sponsor’s own secure electronic systems and these can be used and operated by companies that work with the sponsor. Your encrypted personal data and your medical record will be kept in accordance with the law after the end of the clinical trial. A summary of the study results can also be published at conferences or in scientific journals. However, if the results of the clinical trial are publicly presented, you will never be mentioned by name. Some authorities may require the sponsor to disclose study data for reasons of transparency. The transmitted data will not identify you in any case.

Who at Sponsor can see your personal data?

Only certain research personnel of Sponsor (such as monitors, auditors and sponsor-authorized agents such as contract research organizations (CROs)) has access to your personal data to verify the accuracy of the records. These persons, for example, have access to your medical records collected by investigator and check whether the data has been correctly entered into the study database. These persons are subject to a statutory confidentiality obligation.

The following persons only have access to your encrypted data: ABCSG, ABCSG GmbH, third parties (including possibly also third parties which are subject to a different legal system).

What is anonymized data and who can process it?

The sponsor may anonymise your personal data. Anonymizing means that your personal information is no longer associated with your person and can no longer be traced back to you. There is no code on this data that could be broken down, therefore anonymous data is no longer considered personal data. The anonymized data may be transmitted by the sponsor to external parties. With this data, for example, research is carried out to find out about better treatment options for the future, or more about a disease.

Last modified on May 24, 2018

Share on