Registry Working Party

The 3 levels: datasets and driving questions

Home/ Working Parties/ Registry Working Party/ ESID Registry/ The 3 levels: datasets and driving questions

This section contains a description of the three Levels and (technical) documents on the ESID Registry; in particular, the complete Level 1 dataset with field definitions and driving questions as well as the Level 2 dataset ( unPAD study).


Documentation process

Pdf, 34.43 kB

Slides and flow charts describing the documentation process in the ESID Registry
Oct 18, 2013

Level 1:

  • Level 1 is mandatory for each patient.
  • All parts of Level 1 must be completed.
  • At initial registration (“baseline”), there are sections on diagnosis, HSCT and Ig replacement that need to be completed.
  • At follow-up, the system asks for a status update and for changes in therapy. If the patient has died, or the diagnosis has changed, details on these changes can be documented.
  • The system will ask you to update your patients at least once a year. If you miss to update some patients, the system will automatically send a reminder one year after the last respective documentation date with a list of the ESID-IDs of these patients.

Level 1 Datasets:

Corresponding questionnaires are provided that can be applied to patients and physicians to collect the necessary data items for the new ESID Registry.

Updated version, 2024


Level 1 Driving Questions:

These are the driving research questions underlying these datasets:



Level 2:

  • At level 2 we ask for lab values, detailed clinical features and more details on treatments (on top of Ig replacement, immune modifying treatment and HSCT).
  • The level 2 data models can be category specific, disease specific, or disease group specific (e.g. UnPad, GAIN).
  • Level 2 is optional. If you do not have the resources, you will not have to work on level 2 at all. Depending on your research interests or the type of patients you attend, you can also choose to document level 2 for selected categories or even selected patients only.

Level 2 Datasets:

These are the datasets for level 2 documentation which is optional.

Currently the dataset for the UnPAD Study is available.


unPAD Level 2 Dataset

Docx, 150.16 kB

Updated version, Okt 28, 2016

Please refer to the registry studies section on the website for further information on the unPAD study.

Level 3:

  • In addition, there are dedicated studies on level 3. These shall have a fixed time frame (e.g. four years) and address specific questions defined by a study protocol, including a statistical evaluation plan and a „feasibility assessment“. Level 3 studies can be extended (e.g. to increase the recruiting rate).