Abstract: Systems and processes for managing and supporting clinical trials and clinical trial operations, more particularly for managing and supporting governmental authority, ethics committee, and/or other regulatory authority notifications and submissions in the context of clinical trials in various countries throughout the world. Such systems and processes leverage the insight that such regulatory authority requirements vary from one country to the next, but that all or essentially all such regulatory authority requirements can be categorized into a limited number of groups as to which a limited number of workflows can be created. Such workflows can be automated and supported with systems and processes according to embodiments of the invention, which can then control sequence of activities to comply with regulations and requirements in the various countries in which a clinical trial occurs.

Abstract: Systems and methods are disclosed for managing site visit report creation. Data relationships and process flow rules can be utilized to output reminder messages regarding deadlines associated with a site visit report completion and determine and present proper questions to associates to elicit relevant information about a site visit. Site visit reports can be generated in an efficient and accurate manner and submitted quickly to a sponsor.