Instruments that create data in a digital format are a common source of information that is directly linked to the study database. Such a connection must also follow strict rules and may be difficult to achieve. For example, when different laboratories are involved, they all must adhere to the same data entry standards, normal ranges of their analytical methods, etc.
Some examples of direct data capture (DDC) are:
- laboratory data – generated either by central or local labs
- Clinical assessment data (i.e. electrocardiogram, ECG)
- central image reading – for example, Magnetic Resonance Imaging (MRI) results
- electronic patient questionnaires or diaries.
More recently, mobile apps can provide data by monitoring, for example physical activity or quality of sleep.
EUPATI-Accademia del Paziente esperto (AdPEE) Toolbox Glossary