The Registry is governed by the Head of Registry and the EBMT Executive Committee. There is also a Registry Committee dedicated to Registry matters.
Registry data is entered and maintained in a central database with Internet access. Each EBMT centre is represented in this database and users from a centre can enter, view, modify, obtain reports and download their own data once the necessary permissions have been granted by the Principal Investigator of the centre. In addition, all EBMT member centres can obtain general overviews of the complete EBMT data. The database is run and accessed through a system called ProMISe (Project Manager Internet Server).
National registries operating in some countries are integrated in the EBMT data flow by mutual consent, and use the same central database. A small number of national registries enter data for their centres.
The EBMT Registry Office in London is in charge of checking the whole subset of data, feeding back information to the centres on the quality of their submissions, and requesting follow-up information. National Registries also perform similar checks.
The ProMISe Data Management System
ProMISe (Project Manager Internet Server) is the central data management system used by the EBMT. Access to the Registry is password-protected through individual accounts, and users are able to enter and retrieve data directly over a secure Internet connection. All users access the same data repository but data visualisation is restricted to the user's centre data. The only software necessary is Internet Explorer.
Security in ProMISe
Data is stored on a secure server in the Leiden University Medical Centre, the Netherlands. Download the document below for information on this secure environment.
The confidentiality of the patient data stored in the Registry is of paramount importance to the EBMT and procedures are in place to ensure the data is transferred and stored with the highest possible level of security.
In addition to the above, the transfer or storage of confidential patient data must abide by the General Data Protection Regulation (Regulation (EU) 2016/679, hereafter “GDPR”). As the EBMT is registered as a Dutch foundation, Dutch law applies to the EBMT, and we abide by the implementation of the European Union (EU) GDPR regulating how personal data is to be handled, through the Dutch application of this law.
The law regulating transfer of data within the EU does not cover countries outside EU/EEA (European Economic Area), and the EBMT must ensure that centres lying outside this zone agree to conform to the EU law as stated above.
The law requires that the patient consents to the data being transferred to the EBMT. In addition, if the centre intends to forward data, either directly or through the EBMT, to countries located outside the EU/EEA, they must ensure this is explicitly stated in the patient consent form. Please see the example consent form below. It is the centre’s responsibility to ensure that the patient has consented before data is forwarded to the EBMT.
To use ProMISe your PC will need to meet a number of technical requirements. Click the link below, then click "Run the Tests" to find out whether your PC is compatible. The test page contains full instructions and links for updating your computer.
The Definitions Group is a permanent body that supervises the content of the data collection forms, giving particular attention to the accuracy and reliability of the clinical definitions of each of the collected data items.
The Definitions Group is not responsible for the actual content of the data collection forms, but is responsible for the way it is presented, the consistency across forms, the existence of an accurate definition for each data item in the MED-AB Forms manuals, and for making the language used accessible to the multilingual and multitasking audience that are the centre staff responsible for data management. It will also advise the Working Parties (WP) or Scientific Council on the advisability, or non-advisability, of collecting certain data.
The Definitions Group is made up of representatives of each Working Party, a representative of the Data Offices and a representative of the integrated National Registries that collaborate with the EBMT. The remit of the group is to:
- Reach consensus on definitions or other issues being debated which affect the data collected in the EBMT Registry
- Be available for answering questions from data managers (filtered and routed through the Registry)
- Ensure the definitions in the manual are up to date
- Actively participate in editing the MED-AB forms when needed
- Liaise with the respective WPs, the Board, the Principal Investigators and data managers of the centres to ensure everybody is informed of decisions regarding definitions, MED-AB forms and the Registry