Regulatory Submissions, Information, and Document Management Forum

All clinical content and data trace their origins to the clinical study protocol. Currently there is no internationally harmonized format or content standards for the protocol document. It’s often submitted as essentially electronic paper (PDF) with limited ability to leverage the wealth of information with. The lack of a structured, electronic, harmonized protocol contributes to inefficiencies and difficulties in reviewing and assessing clinical protocols across stakeholders. This session will provide an depth overview of the ICH M11 Clinical electronic Structured Harmonized Protocol (CeSHarP) including the latest developments on an (1) international guideline, (2) protocol template, and (3) internationally accepted technical specification (implementation guide) to promote development of structured and unstructured protocol content, application of international data standards, and interoperable/compatible electronic exchange.