Project Management for Investigator Initiated Clinical Studies ―Consolidation of the Clinical Study Support Systems in the Center for Clinical Research, Shinshu University Hospital―

In the aftermath of the investigation of misconduct in the research of an antihypertensive drug, the quality assurance of planning, operations and results/data became an emergent issue for investigator initiated clinical studies. The recently enacted guidelines and laws on the clinical studies oblige researchers to follow many procedures to assure and maintain the quality in an objective way. The compliance with these regulations, however, would...