2014 - Webinar On 10 Steps to an FDA-Acceptable Clinical Trial Protocol

The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial. There are many schools of thought about the best approach to writing a clinical trial protocol depending on individuals or organizations sponsoring a given clinical trial.
Areas Covered in the Session :
The overall structure of a protocol and regulatory requirements
Identify who contributes to the protocol development and amendments
The element of a protocol such a background scientific rationale, design (single blind, double blind, randomized, etc.), primary and secondary endpoints, inclusion/exclusion criteria, the Schedule of Events, adverse event management, statistical parameters, informed consent, and study synopsis
Practical issues with protocol writing such a differences in various phases of clinical trials, the protocol review process, using key opinion leaders, and using public resources and templates
Common issues with FDA and IRB approval of clinical protocols.
Who Will Benefit:
Regulatory Affairs Professionals
Sponsors of INDs
Senior Management Executives (CEO, COO, CFO, etc)
Drug Discovery and Development Professionals (R&D and CMC)
Clinical Trial Managers
Project Managers and Clinical Trial Specialists
Regulatory Compliance Associates and Managers
People Investing in FDA-Regulated Product Development Projects
For bookings and more information contact
Compliance Trainings
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