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Case Report Form (CRF) - FACILITATE

Case Report Form (CRF)

Commonly referred to as CRF, a case report form is a paper or electronic data entry form used in clinical trials. It is used by sites taking part in clinical trials (such as hospitals) to collect data about each trial participant. All participants data points involved in the Clinical Trial including data on on adverse events, is held in the case report form.

A case report form is developed specifically for each clinical trial so that all the data needed to answer the research question is captured. The organization running the trial is responsible for designing a case report form in line with the protocol of the trial. They must also monitor and audit the data that is collected to ensure it is complete and accurate. Personal data such as the patients’ names, medical record numbers, and any other identifying information are not disclosed in the CRF’s. Each patient is instead given a unique identifier.

EUPATI-Accademia del Paziente esperto (AdPEE) Toolbox Glossary

To go in depth

Basics of case report form

This article describes the methods of CRF design in clinical research and discusses the challenges encountered in this process.
Ballary S et al. Basics of case report form designing in clinical research Perspect Clin Res 2014 Oct-Dec; 5(4): 159–166

The Case Report Form. Part 1 and 2

The following videos (Part 1 and 2), realized by the GCP-Mindset-All About Clinical Research channel, explain in detail what a Case Report Form is.


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