Tutorial #1: Results Disclosure 101: Operational Basics

Overview

Tutorials are not included in the meeting registration and require a separate registration fee

Tutorial Registration: 12pm-1pm

This half-day tutorial introduce the operational basics of results disclosure on ClinicalTrials.gov and EudraCT, with the goal of providing participants with practical content, resource material, and time-saving tips to assist them as they begin a results disclosure project within their organization. Topics include posting requirements, data sources and formats, internal roles and responsibilities, an overview of some nuances of the ClinicalTrials.gov and EudraCT systems (no hands-on training), and strategies for posting, planning, and tracking the work. Along with content presentation, there will be opportunity for facilitated peer interaction and extended Q&A.

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Learning objectives

At the conclusion of this tutorial, participants should be able to:

Define what’s in scope, timing, and requirements for posting results on EudraCT and ClinicalTrials.gov
Identify data sources for the modules in each system, including study documents, ad-hoc tables, xml files
Describe definitions, ambiguities, differences and similarities of some of the fields of the EudraCT and ClinicalTrials.gov systems
Determine internal stakeholders and appropriate levels of responsibility, review, and approval
Discuss proactive strategies for posting, planning and tracking the disclosure process

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Tutorial #1: Results Disclosure 101: Operational Basics

Overview

Who should attend?

Learning objectives

Be informed and stay engaged.