Privacy policy within the ATTRA registry
The purpose of the registry is an overall scientific assessment of data on a large group of patients with inflammatory rheumatic diseases by collecting comprehensive information on these patients. The purposes of data collection and processing in the registry involve monitoring the effectiveness and safety of biological therapy, standardization of treatment procedures for patients treated with biological and targeted synthetic DMARDs and evaluation of the compliance of treatment procedures and long-term benefits of therapy with national guidelines for targeted treatment of rheumatic diseases. The registry contains data from medical records necessary for the above-mentioned registry goals.
The patients included in the registry are not subjected to any additional examinations, no unproven new drugs are administered to them, and their participation in the registry cannot affect their treatment in any way. Patients continue to be treated in accordance with standard clinical practice and at attending physician’s discretion.
The processing of personal data is governed by several laws, in particular by the requirements and provisions of Act No. 101/2000 Coll., on the Protection of Personal Data and on Amendment to Some Acts, as amended, or any new legal regulation replacing the original act (local Czech republic law), as well as in accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (hereinafter referred to as “GDPR”).
The attending physician or medical staff authorized by him shall enter data about each patient’s treatment and state of health into an electronic data capture system under a unique numeric code (ID) and in the scope which does not allow an unambiguous identification of a given patient without using other pieces of information, which are included in medical records. Only the attending physician and/or medical staff authorized by him who enters the data has access to this information. No other person accessing to the registry is able to identify the patients in it.
All published outputs are fully anonymous and summarized for a large group of patients, so nobody is able to identify individual patients.
The Czech Rheumatological Society is the expert guarantor of the registry.
The registry operator, which ensures the organizational, technical and analytical management of this project is the Institute of Biostatistics and Analyses Ltd, company ID: 027 84 114, business address Poštovská 68/3, 602 00 Brno, Czech Republic (hereinafter referred to as the „IBA“). IBA has implemented and follows such technical and organizational measures that ensure the highest level of safety, accessibility and integrity of the processed data, especially the managed access into the registry only to authorized persons (cooperating medical staff, designated IBA employees, project guarantee/sponsor) based on their access rights. All IBA employees, as well as the attending medical staff, are bound by confidentiality. Additionally, all IBA employees and the cooperating medical staff are trained and familiarized with principles and rules for personal data processing in the form of binding standards.
Data on each patient can be only involved in the registry strictly under conditions of granting of his/her explicit informed consent with participation in the registry and with processing his/her personal data in scope and for purposes stated in detail in the informed consent, which the attending physician has at his/her disposal.
On the contrary, each patient can cancel his/her participation in the registry at any time without giving any reason. This decision will not affect his/her further treatment in any way.
Personal data of cooperating physicians (investigators) are also processed in the registry. These personal data are processed for purposes stated in the contract, for setting up user accounts, entering data on patients and ensuring the communication necessary for a fluent operation of the registry and for achieving a high quality of collected data.
Protection of your privacy as well as your health are very important to us and we are glad you are helping us find ways for further improvements of patients’ treatment and health!