Concept 1: To make database capture compatible with real life

Solution: 3 levels of data capture

Level 1 - Minimal dataset – 80 - 100 items

  • Designed so that all necessary data can be entered within 15 minutes
  • Is best suited for new patients with prospective data collection
  • Suitable to test the feasibility of studies
  • Provides answers on the “epidemiology of experts centers”

Level 2 - Extended dataset – 250 items

  • This dataset is designed to cover 80% of data needed for any kind of study
  • Data is expected to be captured within a vast majority of (>80%) of level 3 studies
  • Or on a routine basis based on local NEN referral center decision
  • Ideally, the extended and minimum datasets should be captured at the same time

Level 2, in the DB section “additional” – approx. 50 items:

  • This section will evolve over time
  • Information (including comorbidities, adverse events, if tissue has been stored in a biobank) is expected to be captured within the majority (>50%) of level 3 studies
  • Or on a routine basis based on the decision of the local NEN referral center.

Level 3 – A variety of specialised datasets that will be developed and are project driven.

  • Level 3 datasets are based on levels 1 and 2.
  • In each project, existing items (of levels 1 and 2) are used and new required items are programmed in addition.