Understanding & Implementing The Revised NIH & FDA Clinical Trial Protocol Template

Teachers
Michael Pierro
Category:
Clinical Trials (GCP Training)/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

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.  Since the template was revised last year, there are subtle and nuanced changes that you should understand before applying to your studies.

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:

  • Important pieces of the template, and how it differs from conventional protocols
  • How to interpret the template requirements, and marry them to your current efforts
  • Important pitfalls to avoid and risk mitigation strategies
  • Implementation of the template and strategies for continuous improvement

Who Should Attend

WHO SHOULD ATTEND

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).

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Pierro
Michael Pierro, a highly experienced facilitator and subject matter expert, provides clinical operations and GCP/SOP training to the biotechnology, CRO and pharmaceutical industry.

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