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Electronic Clinical Outcome Assessment (eCOA)

What is eCOA? Electronic clinical outcome assessment (eCOA) is an electronic version of a clinical outcome assessment, and functions to record the health status of a study subject based on specific measures. It provides a more efficient, accurate, and customizable solution than traditional paper- based assessments.

What are the measures recorded by eCOA?

eCOAs can be used for:

  • Patient-reported outcomes provide a record of how the subject is feeling at a certain point based on questionnaires or through a record of the frequency of specific events.
  • Observer-reported outcomes provide a record of observable changes by someone who is involved in the patient’s daily life. This can include caregivers or family members, and is used when the patient cannot report for themselves, such as with pediatric patients or those with dementia. These reports may include rating scales or a record of the frequency of clinical signs, events, or behavioral changes.
  • Clinical-reported outcomes are a record of clinical signs, events, or behavioral changes that are reported by a medical professional. These can include a report of clinical findings and related testing data or the results of clinician-observed rating scales.
  • Performance outcomes refer to an objective measurement of the result of tasks done by a patient according to standardized instructions. 

Source: FDA. (2020, December 2). Clinical Outcome Assessment (COA): Frequently Asked Questions. U.S. Food and Drug Administration. Retrieved June 29, 2022, from https://www.fda.gov/about-fda/clinical-outcome-assessment-coa-frequently-asked-questions.