SOP 04: Data Collection Forms (Case Report Forms)

The format, extent, and language of data collection forms (Case Report Forms (CRFs)) are generally not prescribed in detail by guidelines on Good Clinical Practice. As a general rule, however, CRFs should provide a complete documentation of all findings as required by the trial protocol and other relevant observations. CRFs should be adapted to the requirements of a particular study. Examples for CRFs used for phase II studies conducted by CESAR are appended to this SOP. These need to be adapted according to protocol requirements of individual trials. Additional parameters not included in the sample CRFs may be recorded on additional, study-specific forms. In exceptional cases – in particular for phase I studies or when multicenter phase II studies are performed in cooperation with other study groups – CRFs provided by a sponsor may be used. However, such forms should contain as a minimum at least the parameters required by the standard CRFs of CESAR. The decision as to the use of such forms will be made by the Chair of the working group in consultation with the Coordinating Investigator (see ‘SOP 2: Evaluation and Selection of a Clinical Trial Proposal for CESAR’) and the statistician of CESAR’s data center.