Case Report Form
The Case Report Form (abbreviation CRF - German called CRFs in electronic form eCRF ) is a data entry form (paper form or electronically ), which states the corresponding required in the test plan a clinical trial study data of a patient ( healthy volunteer) and to the client, in typically, a pharmaceutical company ( Pharma research), are reported. This coverage usually takes place in an anonymous form. So-called " adverse events " that are logged in this survey form, can be listed as a side effect of a subsequent authorization of a medicinal product in the package insert.
In the recent legislation of the Federal Republic of Germany dealing with the case report forms is regulated by law, " sponsor " (eg pharmaceutical company ) " ensures that the essential documentation of the clinical trial including case report forms after the termination or discontinuation of the trial at least ten years are kept. Other provisions for the storage of medical records shall remain unaffected. " ( From the regulation on the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use from 9 August 2004).
- Clinical Research