A CRF is a case report form in clinical trials. A CRF is used to collect data from patients participating in clinical studies. It records personal information, such as age, weight, and height, as well as the patient’s response to medicines being trialed. For example, the case report form collects data about any adverse events (AE), such as symptoms related to the use of a drug, and vital signs data (VS), such as blood pressure and temperature.

The terms, case report form and electronic case report form are used interchangeably in clinical trials, as are their abbreviations, CRF and eCRF. Traditionally, case report forms, or CRFs, were paper based and electronic case report forms, or eCRFs, were digital forms. However, both terms are currently used to refer to the same thing. Here’s an example electronic case report form.

CRF design or eCRF design refers to the process of designing your electronic case report form, in line with the requirements of the study protocol. Effective CRF design is essential in ensuring that the correct, relevant information is collected in a clinical trial, in order to give a study the best chance of success.

When designing a CRF, the form must capture all of the required information specified in the study protocol. In other words, the case report form design should match all the points listed in the final protocol, so that the objectives of the protocol are met. The CRF design should be clear, easy to understand, and should collect only the required information, nothing more.