Case report form

The Case Report Form (abbreviation CRF - German test form, in electronic form eCRF) is a questionnaire (paper form or electronic) in which the examination data of a patient ( test subject ) required according to the test plan of a clinical trial is recorded and sent to the client, in usually a pharmaceutical company ( pharmaceutical research ). This reporting usually takes place anonymously. So-called "adverse events" that are logged in this questionnaire may at a later approval of a drug in the package insert as a side effect to be listed.

In the most recent legislation of the Federal Republic of Germany , the handling of the test sheets is regulated by law: “The sponsor” (e.g. pharmaceutical company) “ensures that the essential documents of the clinical trial, including the test sheets, are received after the test has been completed or canceled be kept for at least ten years. Other regulations for the storage of medical records remain unaffected ”(from the Ordinance on the Application of Good Clinical Practice in the Conduct of Clinical Trials with Medicinal Products for Human Use of August 9, 2004).