This is data collected in a clinical trial by:
- the investigator and study staff
- directly by patients (called Patient Reported Outcomes (PRO)
- directly by caregivers (called Observer Reported Outcome (ObsRO)
This can occur in the traditional way – on paper (such as Case Report Forms (CRF), patient diaries, or questionnaires); or in electronic ways – for instance in electronic CRFs (eCRFs), or by using hand-held instruments such as mobile phones or tablets to collect data directly from patients (ePROs). Another method of collecting data is called Direct Data Capture (DDC). In DDC,data are directly generated by electronic devices and entered in the database.
EUPATI-Accademia del Paziente esperto (AdPEE) Toolbox Glossary