Guide to Clinical Studies and Developing Protocols

abnormal acceptable active additional administration adverse reactions allow analysis and/or approach appropriate Assessment baseline bias blind blood changes characteristics clinical study complete conducted considerations considered contain criteria data collection forms DCFs defined described determined discontinued discussed disease dosage dose drug studies duration effect efficacy entered established evaluated examinations example factors forms given important indicate individuals informed consent initiation investigator involved laboratory levels listed means measure method monitor normal objectives observed obtained occur packaging parameters patients performed period Phase placebo placed points possible potential prepared present prior problems procedures protocol questions randomization reasons receive records referred relevant reports response route safety sample Scale schedule screen Selected separate significant situations specific sponsor standard study design study drug Table tests treatment Treatment Group usually values various week