The lack of international harmonization around the structure and content of the clinical trial protocol document creates many challenges and inefficiencies for regulators, sponsors, ethical oversight bodies, investigators, and other stakeholders as they review and assess clinical protocols. The development of an international ICH guideline and template can potentially alleviate these challenges by helping to support consistency in the development of structured and unstructured protocol content.
In this webinar, industry leaders will discuss the challenges caused by the lack of international standard protocol template harmonization and present current ICH CeSHarP strategies that may help to minimize these challenges and multiple approaches to improve the protocol authoring process.
Rob DiCicco, PharmD
Deputy Chief Health Officer
IBM Watson Health
Vivian Combs, MS
Advisor/Process Owner, Clinical Systems & Supply Planning
Eli Lilly and Company