Electronic Databases

Information and tools to conduct quality clinical trials of new drugs, devices and biologics. Provides explanations of laws, federal regulations and international harmonization efforts and analysis of accepted good clinical practices.  Includes sample checklists for conducting quality assurance audits, FDA forms, industry guidance documents and information sheets.   Also provides news and analysis on key developments in conducting clinical research, and access to clinlaw, an online database of state and federal clinical trial requirements.