CRFs are designed to reflect the needs of the protocol in collecting the appropriate data for analysis. Most companies now recognize the need for cross-functional teams to be involved in the CRF creation process.
Design a CRF that will collect the necessary data in a way that it is clear and easy for the investigator, efficient for data management processing and appropriate for analysis.

This complex goal must be achieved by balancing standards with the needs of the individual study and by into account preferences of the team members and investigators. The efforts necessary to manage the varied needs while negotiating the human issues involved in the process is something that is different at every company, but certain basic CRF design principles apply everywhere.     

In general, all CRFs have to be created according to the same principle despite whether they are created electronically or on paper. Besides that they have to represent all relevant items of the clinical study protocol, they have to be clear and univocal in order to avoid a large increase in time needed for data cleaning after the study is finalised.

During the workshop the participant will get the basic theory of CRF design. Different possibilities and solutions for problems are discussed. The following subjects will be handled during the workshop:

• consequences of differences in study designs
• translating a study flow chart into a CRF
• instructions for completing CRFs
• repetitive data
• obligatory/non-obligatory questions
• graphic & layout
• differences between electronic and paper CRFs
• Standards