The National Institutes of Health (NIH) and the U.S. Food & Drug Administration (FDA) are suggesting a standardized format for protocols utilized in conducting Phase II and III clinical trials under an IND (Investigational New Drug) or IDE (Investigational Device Exemption). Investigators applying for NIH grants must use this template. However, since FDA is involved, they are suggesting that sponsors and investigators also follow the template and retain the sections in the order provided. This course will discuss the template and review the various sections to provide course attendees with an understanding of the required format as well as preparing for implementation.
During this interactive, 90-minute session, you will learn:
This course will be of benefit to anyone who is involved in drafting, reviewing, amending, and submitting clinical protocols for Phase II and/or Phase III clinical studies (e.g. investigators; clinical research staff including Medical Writers, Study Managers etc.; Quality Assurance staff and Regulatory Affairs staff who review protocols).
For over 10 years, Michael Pierro has provided consulting services to the Biotechnology, CRO and Pharmaceutical Industry in the areas of clinical operations (Standard Operating Procedures, Project Management and Clinical QA GCP auditing) and GCP/SOP training (live & Internet delivery). In this work, he draws on over 30 years of experience in clinical operations and training in the pharmaceutical & biotechnology industry.
Previously employed by Barnett International, Michael served as Director, Business Development: Consulting & Clinical Training responsible for development and implementation of GCP related standard operating procedures, specialized compliance related training programs and related consulting services. Clients include Pharmaceutical, Biotechnology, CROs, University Medical Centers and US Federal Government.
Immediately prior to joining Barnett, Michael was Director of Global Training for Hoechst Marion Roussel’s (Aventis) Global Clinical Quality Assurance Department. In this role, he directed all GCP Auditing, SOP and technical training programs and activities within the company’s Global Drug Development Center and other development sites throughout the world. In previous roles with Hoechst Marion Roussel and other major pharmaceutical companies, Michael served as a Senior CRA, Manager of Phase IV Clinical Operations and Chairperson of the SOP Steering Committee and GCPAuditor. He was involved in several NDA and SNDA preparations and filings as well as other reports to the regulatory agencies.