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.