When submitting a NEW CLINICAL PROTOCOL as part of an IND application, consider the following:

1 For Phase 1 trials: - Early developmental protocols should specify in DETAIL ALL THE ELEMENTS of the study that are CRITICAL TO SAFETY. 2 For Phase 2-3 trials: - All the above-described expectations for ADEQUATE SAFETY ELEMENTS also apply to Phase 2-3 trials; - Detailed protocols describing EFFICACY & SAFETY be submitted. OBJECTIVES & PURPOSES of a trial should be clearly stated, including description of the observations and measurements to be made to fulfill the objectives of the trial - Clinical trial protocols should include a clear description of TRIAL DESIGN and PATIENT SELECTION criteria as well as description of CLINICAL PROCEDURES. laboratory tests, and all measures to be taken to MONITOR the effects of the drug