PROs and Data Collection


1. Types of Data Capture

Data in a clinical trial are generated and collected by the investigator, the study staff or directly by patients (called patient-reported outcomes - PROs).

This can occur in the traditional way on paper or in electronic form:
  • CRF - Case Report Form - on paper including patient diaries or questionnaires.
  • eCRF - Case Report Form – electronic.
  • DDC - Direct Data Capture i.e. through electronic devices, data entered automatically into a database.
  • PRO - Patient-Reported Outcomes - patient questionnaires and diaries - on paper.
  • ePRO - Patient questionnaires and diaries – electronic via hand-held instruments like mobile phones or tablets.