Table 2.

The three principal methods of obtaining clinical data in ordered processes for trials, quality control, quality registries and as real-world data.

Principles	Method	Pros and cons
EMR extraction and post hoc reconstruction of sequence	Data extracted based on a manually determined index date and assigned meta information on the nature of the content	This requires manual mapping and post-assignment of semantic meaning to each data point which makes it less robust.
Index date method as used in most Case record file (CRF) methodology or quality registry protocols. Often parallel data collection outside the clinical process	An index date is set prospectively, and all data is annotated in the CRF or other repository with respect to the time-point. EMR is separate and used for reference only.	This method is robust but laborious. It necessitates a setup of a dedicated data-capture method often as a one-off construct (a CRF).
Care plan annotated data	Data is captured and annotated with the information on what care plan is used and the placement of the action in the care plan	The method that we have developed to continuously extract quality data, process data and real-world data from the clinical activity. Allows concomitant care plans that guide data capture for different purposes.