Electronic Clinical Outcome Assessment (eCOA) Instrument
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An Electronic Clinical Outcome Assessment (eCOA) Instrument is an clinical outcome assessment instrument that is an electronic data capture format.
- Context:
- It can (typically) facilitate real-time data collection and immediate data availability.
- It can (often) improve data accuracy and reduce errors associated with manual data entry.
- It can (often) support multi-language options to accommodate diverse patient populations.
- It can (often) include functionalities such as automated reminders for participants.
- It can be built using an eCOA Builder.
- It can range from being a simple mobile app to a comprehensive web-based platform.
- It can integrate with electronic health records (EHR) systems to streamline data sharing.
- It can be deployed on various devices, including smartphones, tablets, and computers.
- It can be used in various clinical settings, including in-clinic, at-home, and remote monitoring.
- It can comply with regulatory standards such as FDA 21 CFR Part 11.
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- Example(s):
- an ePRO (Patient-Reported Outcomes (PRO)) where patients directly input their data electronically.
- an eClinRO (Clinician-Reported Outcomes (ClinRO)), allowing clinicians to enter clinical data directly into an electronic system.
- an eObsRO (Observer-Reported Outcomes (ObsRO)) where observations are recorded electronically by someone other than the patient.
- an ePerfO (Performance Outcome (PerfO) Measures) which involve patients performing tasks or activities assessed electronically.
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- Counter-Example(s):
- See: ePRO Data Collection System.