The Investigator Meeting – Regulatory Requirements and Obligations that Ensure Success

Teachers
Albert Yehaskel
Category:
Clinical Trials/On Demand Courses/Regulatory & Compliance/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

Your clinical protocol has been completed and signed off.  Clinical trial material has been distributed to the various clinical sites.  Your Investigator and sub-Investigator are ready to begin the clinical trial.  Clinical research associates are ready to perform their work in the upcoming trial.  You are ready, correct?  Think again…

How well do your personnel participating in the trial actually know the trial?  Has the investigator brochure been thoroughly reviewed and disseminated?  Are your personnel familiar with the regulatory aspects of what is about to transpire?  Do your Investigators realize that the Form FDA 1572 is a legally binding document?

These questions and more are generally addressed at an Investigator Meeting.  The importance of an Investigator meeting cannot be overstated because it can and will affect patient enrollment/retention, plus have an impact on data quality.  Furthermore, this meeting provides an opportunity for researchers to get together to introduce the study as a group.  Additionally, it allows for questions to be voiced and heard by all in the audience.  Finally it provides adequate training in preparation for the trial.

LEARNING OBJECTIVES

This webinar will provide an overview of the Investigator meeting and how it should be conducted.  By attending this session, you will learn:

  1. How to plan for the Investigator meeting: Strategizing the regulatory aspects
  2. Avoiding general pitfalls that derail these meetings – from planning to execution
  3. The general requirements of a good meeting
  4. The Regulatory Package – Understanding the necessary documents for a successful clinical trial
  5. Understanding the legal requirements – dotting “i’s” and crossing “t’s”

Who Should Attend

WHO SHOULD ATTEND

This course will be valuable to anyone working in a clinical environment as a fundamental understanding of why the Investigator meeting is important, what is contained within, and the action items that come from it are critical to the success of any clinical trial.

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

Albert Yehaskel
Focused on solving New Drug Development issues for small and medium sized companies.

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