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

Teachers
Michael Pierro
Category:
Clinical Trials/Regulatory & Compliance/Research & Development/Upcoming Live Courses/
Clear
Duration: 90 minutes
August 21, 2018 | 1 PM EDT
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 will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.

To access the course, you need only a telephone and computer with internet access.

This webinar is scheduled for live instruction on
Date: August 21, 2018
Time: 1:00 – 2:30 PM EDT

Choose to participate live or listen to the recording afterward!

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.

The recorded version of the training will be available for 30 days after purchase.

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
30+ years of experience in clinical operations and training in the pharmaceutical & biotechnology industry.

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