en
Dictionary:
Completed

National data collection system

The purpose is to investigate opportunities and prerequisites for a national data collection system (Electronic Data Capture (EDC) system) and a central randomising function for academic research. The project shall also investigate the opportunities and a possible operating format for these functions in a central or regional body.

Background

EDC (Electronic Data Capture) systems and eCRF (Electronic Case Report Form) are computerised systems for collecting and storing data in clinical trials. There are many systems for these purposes. A good system for academic studies is lacking – many of the existing solutions are expensive and include functions that are more advanced than necessary for academic studies.

Goals

The project shall:

  • make an inventory of the requirements on a data collection system with functions for data storage and randomised allocation of study participants to treatment groups
  • produce a requirement specification for a joint national system
  • produce proposals for a national system for academic studies and proposals for a suitable operating format

Time plan

Phase 1 of the initiative started in Q1 2016.

Phase 2 started In Q2 2017 and is expected to be completed by Q1 2018.