3. What is a Case Report Form (CRF)?

3.1. CRF Content

Here are some examples of data that are typically collected in a CRF:
  • Inclusion and exclusion criteria (features a patient needs to fulfil to get enrolled into the study).

  • Demographics (the patient’s personal information in an anonymised way).

  • The patient’s medical history and the result of the physical examination by the doctor.

  • A description of the diseases that the patient currently has and the medicine they are taking.

  • Efficacy and safety parameters (measurements that show the effect of the medicine and the potential side effects the patient is experiencing).

  • Which medicine, usually in a blinded fashion, was administered.

  • Termination of trial (the result of the final examinations and confirmation of the patient’s completion of the study).