Clinical Trials Conduct: Industry perspective - Documents impacted during study conduct

11:50 AM - 12:25 PM

Focusing on the documentation potentially impacted during study conduct providing their perspective and experience, and medical writers role in these.  Considerations will be discussed when planning changes an ongoing Clinical Trial under the EU-CTR such as a modification submission, assessment timelines and requests for information and how this involves and impacts medical writers   

A focus will further be given to the legal requirements under the EU-CTR for the identification, management, and required reporting of serious breaches and the reporting of unexpected events which affect the benefit-risk balance of the clinical trial, and how medical writers can reflect this in their documents.