Regulatory Submissions, Information, and Document Management Forum

The pandemic has taught us that clinical trials need to happen quickly and involve many regulators, pharma companies, investigators and clinical sites all over the world. One common necessary tool to conduct a trial is the clinical protocol. The protocol is a document that provides the roadmap how the trial will be conducted (the purpose, objectives, endpoints, estimands, methodology, and statistical considerations). For decades we have had a harmonized the electronic common technical document format for submission of marketing application, as well as a format and content for clinical study report. However, we have not, until now, had a globally harmonized clinical protocol. The lack of a common protocol template for global clinical trials contributes to inefficiencies and difficulties in the conduct of the study, as well as in the regulatory review, and assessment of the protocol content. The use of an electronic protocol that is standardized in its structure will improve access to consistent and searchable information (e.g., schedule of assessments, objectives, adverse event information) across sponsors, regulators and clinical sites.

This session will provide an overview and the latest developments of the ICH M11 Clinical Protocol Template: 1) Guideline, 2) Protocol template, and 3) Technical specification and how these documents will facilitate more efficient and effective conduct of global trials for global drug development.