Best of 2018 AMWA Conference: Accelerating Drug Development through Protocol Harmonization: TransCelerate’s Common Protocol Template (CPT) and the Technology-Enabled Addition
Your webinar registration includes access to the recording in AMWA Online Learning.
Increasing complexity in protocols makes implementation and reporting difficult, and the lack of consistency compounds the issue. A significant opportunity exists for an improvement in quality and simplification through protocol harmonization, as all protocols rely on the same health care and regulatory infrastructure for design, review, and implementation. Join AMWA for a reprise of this popular session at the 2018 AMWA Medical Writing & Communication Conference. Learn about the collaboration between TransCelerate, the US Food & Drug Administration, and the National Institutes of Health to achieve alignment on a common protocol structure. The TransCelerate common protocol template (CPT) addresses the challenges of the historically manual authoring process that limits the ability to automate content reuse. The CPT provides a common structure and proposed model language for clinical trial protocols.
After participating in this webinar, learners should be able to
- Define the benefits of TransCelerate’s CPT
- Describe how the CPT aligns with industry data standards
- Discuss how the CPT enables downstream automation of many clinical processes
Content area: Regulatory writing
Learning level: All levels of experience
Speaker: Mitzi Allred, PhD, Director, Clinical Operations, Merck & Co., Inc., North Wales, PA
Mitzi is a Director at Merck & Co. where her focus is on structured content management and regulatory writing. She has more than 20 years of experience in the biopharmaceutical industry in regulatory and clinical operations. Mitzi uses process improvement through information design and structured content reuse to leverage time, quality, and efficiency for content within documents. Over the past 15 years, she has led improvements in electronic documents and structured content management reuse implementations. Mitzi participates in the TransCelerate Common Protocol work stream where she is the Lead for integration and innovation. She has a PhD in engineering and 15 years of experience in the aerospace field.