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An Introduction to Clinical Trial Disclosure – the Regulatory Requirements, Industry Commitments, and Protection of Data Privacy and Company Confidential Information

Level:
Foundation
Area:
Drug Development
Code:
DDF36
Duration:
03:30:00
Workshop profile:
This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics. Previous experience or background knowledge of clinical trial disclosure is not required. This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.
Objective:
Attending this workshop will help participants to understand the regulatory requirements (e.g., EMA Policies 043 and 070) and industry commitments for clinical trial disclosure, understand how patients and investigational sites may benefit from this disclosure, be introduced to the new documents required due to the disclosure (EMA Policy 070 anonymisation report, lay summaries, etc.), be aware of the challenges created by clinical trial disclosure for when drafting clinical documents (e.g., protocols, clinical study reports), understand what is company confidential information, personal protected information, and data privacy, and understand how data privacy and confidential information is protected (e.g., using anonymization or redaction). Attending this basic workshop before attending one of the above specialist workshops will enable participants to gain the most benefit from the advanced workshops.
Content:
This will be an interactive workshop combining classical presentations with quizzes and exercises to introduce the topic. The aspects of clinical trial disclosure most relevant for medical writers, including potential new deliverables and challenges during protocol and CSR writing, will be highlighted. This workshop will enable attendees to embark upon workshops covering specialized topics such as the drafting of lay summaries, trial registration and results reporting in EudraCT/clinicaltrials.gov, and the protection of protected personal data and commercially confidential data.