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Thursday, June 28 • 9:00am - 10:15am
#411: Regulatory and Industry Perspectives on the Common Protocol Template

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-693-L04-P; CME 1.25; IACET 1.25; RN 1.25

Protocols are critical components of a medical product development program. Having a standard format and structure, as well as content from CDISC therapeutic area standards will allow sponsors and regulatory agencies be able to find the same information in the same location and it will mean the same thing.

This session will provide an update on the regulatory and industry perspectives on the benefits/challenges of a common protocol template for regulated global clinical trials and progress toward its adoption and maintenance.

Learning Objectives

Describe the benefits of a common protocol template for industry and regulatory agencies; Recognize the challenges of a common protocol template multi-regional clinical trials; Explain the progress toward the use and maintenance of a common protocol template


Robert A. DiCicco, PharmD


Industry Perspective
Kenneth A. Getz

FDA Perspective
Vaishali Popat, MD, MPH

NIH-FDA Protocol Template and the Benefits of Having a Common Protocol Template for Phase 2 and 3 Trials
Cynthia Boucher, MS


Cynthia Boucher

Clinical Trials Specialist, National Institutes of Health (NIH)
Cynthia is currently a Clinical Trials Specialist at the National Center for Advancing Translational Sciences (NCATS). She was recently on special assignment with the NIH Office of Science Policy working on the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template, and a... Read More →
avatar for Robert DiCicco

Robert DiCicco

Vice President, Portfolio Management, TransCelerate Biopharma, United States
Rob DiCicco is the Vice President, Portfolio Management at TransCelerate Biopharma, Inc. Rob joined TransCelerate from IBM Watson Health where he was the Deputy Chief Health Officer. At IBM he worked closely with software designers and developers to inform product roadmaps. Rob also... Read More →
avatar for Kenneth Getz

Kenneth Getz

Executive Director/Professor, Tufts CSDD; Founder/Board Chair, CISCRP, Tufts University School of Medicine, United States
Ken Getz is a Professor and the Executive Director of the Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded studies on pharmaceutical R&D management and execution; protocol design optimization; CRO and investigative site... Read More →
avatar for Vaishali Popat

Vaishali Popat

Associate Directo, Biomedical Informatics & Regulatory Review Science, OND, CDER, FDA
Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

Thursday June 28, 2018 9:00am - 10:15am EDT
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Forum