Table 2.

Required contents of a Clinical Trial Protocol. Additional sections describing the clinical necessity for this trial and a description of how the results of the trial will impact the future care in IBD is often required by the potential funding agencies.

Introduction/Background Objectives of the study Trial Design (open label, double or single blinded) Study population with in and exclusion criteria Concomitant medication (allowed and not allowed) Definition of primary and secondary study endpoints Study procedures with detailed description of each study visit Adverse events, classification and reporting Criteria for withdrawal or stop of study drug Information of study medication supply Randomization, data management and data monitoring Statistical analyses including power analysis for the study*

^*A separate statistical analysis plan might be required