Case report form (CRF)
Case report forms (CRF) are essential study documents to collect data during study conduction (see ISO20916 Annex A.5 and Annex H.16). Information of each enrolled subject is entered contemporaneously and serves as basis for the subsequent study analysis and reporting. Thus, data must be accurate and complete. Importantly, data pseudonymization or if applicable anonymization leads to protection of subjects’ rights.
Collection of data is done either paper-based or electronically. Different software solutions provide the option to collect the data in electronic CRFs. These systems must be validated and must always be managed securely (protected against unauthorized access and against loss, alteration or destruction of data).
