CPT 101: An Introduction to the Common Protocol Template
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Date and Time: October 22, 2019 @ 12:00 PM ET
Contact Hours: No contact hour will be issued for this presentation.
Presenters
Jacqueline Ahn, Associate Director, Pfizer
Meg Steiger, Manager, Eli Lilly & Company
Jennifer Strickland, Senior Principal Medical Writer, Allergan
Dr. Siân Ratcliffe VP, Clinical Operations Head for Oncology in Clinical Development & Operations, Pfizer
Description
The Common Protocol Template (CPT) is a harmonized and streamlined approach to the format and content of clinical trial protocols. It aims to ease interpretation by study sites and global regulatory authorities while enabling downstream automation of many clinical processes and aligning to industry data standards. The CPT includes a common structure, proposed common text, and regulator-accepted endpoint definitions that may be used across protocols with little to no editing at the discretion of the user. The first CPT was released in 2015 and it has been evolving ever since.
During this webinar, attendees will be introduced to the rationale, development and benefits of the CPT. TransCelerate speakers will discuss their Common Protocol Template Initiative and how the organization is interacting with industry stakeholders and regulators to create and maintain a model clinical trial protocol template.
Learning Objectives
1. Understand the rationale, development and benefits of the Common Protocol Template (CPT);
2. Learn about CPT structure: Core Template and Libraries, features of the basic Word and Technology Enabled Editions;
3. Speakers will provide feedback on your exposure to this document template across industry.
Presenters
Jacqueline Ahn is the Associate Director for Governance and Standards at Pfizer. She is responsible for the governance of clinical data standards and protocol development for the Global Product Development organization. Jacqueline has a wide breadth of experience in drug development from pre-clinical research to commercialization of approved medicines. She has been involved with TransCelerate's Common Protocol Template workstream since 2018.
Meg Steiger is a Manager of the Design Hub Scientific Writing Team at Eli Lilly and Company where her focus is on clinical trial-related documents. She has over 12 years of experience in the biopharmaceutical industry in medical writing. Meg particpates in the TransCelerate Common Protocol workstream. Prior to joining Eli Lilly and Company, Meg was a Program Operations Manager and Epidemiologist for the Immunization Program at the Indiana State Department of Health. Meg has a Master of Public Health and Bachelor of Science in Pubic Affairs from Indiana University-Bloomington.
Jennifer Strickland is a Senior Principal Medical Writer at Allergan. She received her PharmD from the University of the Sciences in Philadelphia. Jennifer supports the Dermatology and Device therapy areas by authoring high-quality clinical documents. jennifer has been involved with a number of initiates at Allergan including the implementation of the Common Protocol Template. She has also participated in several workstreams at TransCelerate.
Dr. Siân Ratcliffe is currently the VP, Clinical Operations Head for Oncology in Clinical Development and Operations at Pfizer. Prior to taking on this role, Siân was Head of Medical Writing, leading a global team of writers and quality reviewers engaged in Protocol, Clinical Study Report, Clincal Trial Disclosure and Clinical Regulatory Submission document authorship. Siân has also been engaged with the TransCelerate Common Protocol Template team since 2017 and is a member of the ICH M11 Expert Working Group. Siân brings ~20 years biopharmeceutical development experience in roles across the business in Drug Safety R&D, Clinical Development, Safety and Risk Management, as well as Regulatory Affairs. Prior to joining Pfizer in 2000, Siân previously worked as a freelance editor for the Elsevier Trends Journals. Siân has a PhD in Pharmacology from the University of Cambridge (1996) where she also held post-doctoral research and academic posts, examining the molecular mechanisms of action of photodynamic agents for ablation of pancreatic carcinoma cells.