Conducting Research with Us
Data Collection at the National Register
Patient Protection and Research Quality
Over 55,000 patients, as well as their relatives, contribute to medical progress by donating their data and samples.
From Healthcare Research to Clinical Studies to Genetic Research: Thanks to the National Register’s long-term collection and continuous data administration, researchers are able to identify trends in the field of congenital heart disease that are relevant to the patients’ health. This leads to reproducible and hence comprehensible research results.
It is our top priority to protect the patients by means of collecting and processing data that conform to data protection laws.
A Reliable Basis for International Research
Sustainable results regarding the genetic causes, courses of diseases, healthcare and the quality of life of patients with congenital heart disease can only be generated on the basis of a representative data collection that also allows the description of family relations.
The Register’s nationwide, individual-related and pseudonymized collection of patient data, as well as the data of family members, creates the crucial prerequisite for this endeavor. Thanks to procedures conforming to data protection regulations, data quality is assured and multiple registration of single individuals is prevented. This also facilitates long-term studies that require results from successive analyses to be assigned to one specific individual during the course of the study. As a result, international research is provided with a constantly reliable research basis in Germany.
Different Types of Data are Strictly Separated
The National Register’s databases safeguard a strict separation of individual-related, medical and sample-related data. The patients’ identifying data (IDAT) are stored and processed separately from their medical data (MDAT), as well as their sample-related data (BDAT), if applicable.
The IDAT database (IDAT-DB) is solely used to store and administrate the patients’ identifying data. The sole purpose of the MDAT database (MDAT-DB) is to administrate and store patients’ medical data. Sample-related data are recorded separately in the BDAT database (BDAT-DB).
Patients’ Written Consent is Always Required.
The individual-related collection of medical data can only take place after a patient’s written consent. To consent, patients can use the Yellow Form. Alternatively, if they are participating in a study, consent is given by means of a study-related consent form. Consent to participate in our research is voluntary and can be withdrawn at any time. The Yellow Form can be obtained from many departments of pediatric cardiology and from pediatric cardiologists in private practice. It can also be downloaded in the patient area on our homepage. By means of the signed document respective patients transfer their personal data and give their permission to
- the long-term storage of both the personal and medical data
- the Register requesting a medical record, i.e. releasing the treating physician from their obligation to confidentiality. For this purpose, the treating physician’s contact details are also recorded on the Yellow Form.
- be contacted in writing or by phone (for sending information, inquiries regarding the participation in studies, address maintenance etc.).
Detailed Description of Data Collection
The patients’ identifying data (IDAT) are stored and processed separately from their medical data (MDAT), as well as their sample-related data (BDAT), if applicable. Datasets are recorded in pseudonymized form. They are linked by using a PID generator.
- Patient actively enrolls in the register
For this, the patient completes the Yellow Form. Furthermore, registration can also take place within the scope of participating in one of the Competence Network’s studies. This requires the patient’s written informed consent at the beginning of the study, allowing their personal and medical data to be transferred to the Register upon completion and analysis of the study.
- Informed Consent
Not until patients have given their written consent does the Register request the medical report and record the personal identifying data (first name, last name, date of birth, sex, nationality, contact details).
- Contacting the treating physician
The Register requests the medical report from the treating physician. This step is canceled only when the treating physician actively supports the enrollment in the register and after written consent has been obtained, when named physician forwards the medical records and the registration form to the register.
- Entry of the identifying data
Upon entry of the personal identifying data to the IDAT-DB, the PID generator generates a PID code that ensures the pseudonymization of the data. Subsequently, the personal data are stored in the IDAT-DB.
- Entry of the medical data
Data derived from the medical report are recorded in the Register’s MDAT-DB, which is separate from the IDAT-DB. For data storage the IPCC-Code (International Paediatric and Congenital Cardiac Code) is used, which is acknowledged throughout Europe. Upon web-based data entry, the code is automatically assigned by clicking on the appropriate diagnosis, operation or intervention. This prevents input errors.
Only access authorized Register staff is allowed to enter data. Register staff members have strictly separated access rights and functions when it comes to the entry of either individual-related data to the IDAT-DB or medical data to the MDAT-DB.
Thanks to the present rights and roles concept, the web-based entry system also allows for performing register studies, as well as for setting up separate research databases for other project groups.
Good to Know
Data Protection and Pseudonymization
Upon entry of the personal data of a study or register participant, a pseudonym (patient identifier: PID) is generated on the basis of the personal data. Each individual’s PID is distinct and used throughout all databases as a means of assignment. The PID generator was developed at the Competence Network Paediatric Oncology and Haematology as a tool to generate pseudonymous patient identifiers (Reng, Debold, Specker, Pommerening: Generische Lösungen zum Datenschutz für die Forschungsnetze in der Medizin. Schriftenreihe der TMF, Band 1, März 2006). It is used in numerous medical research networks. The PID functions as a classification criterion throughout all databases of the network. By its being unambiguous, it both guarantees secure work processes and ensures the adherence to data protection laws.
The samples of the biorepository are assigned an additional code, the so-called LabID. This second step of pseudonymization protects the samples from being re-identified in an unauthorized manner. The LabID is printed on labels as a barcode and is used to record and administrate samples and sample information sheets.collapse