Figure 4.

Extended PCROM (Clinical Research Information Model). Shown is the extended PCROM as UML class diagram. The “Care related area” (green) and the eCRF (ENTRY) area (yellow) are framed by as bold line. New objects are indicated by bold framing in purple and in some cases in additional colouring. Objects with a tight connection to the CARE or ENTRY area are shown in the corresponding colour. For example, the class “Invitation of patient” and HealthCareSite are in green, because they belong to the CARE area. In the ENTRY area classes that constitute the concept of a functional eCRF are shown in yellow (e.g. ObservationActivity, ObservationResult, AssessmentActivity). New objects not belonging to CARE or ENTRY areas are coloured in purple (e.g. Alert/Alarm, TTP). New relationships introduced are indicated by bold arrows in purple.