New FDA Draft Guidance – A Risk-Based Approach to Monitoring of Clinical Investigations

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials/ On Demand Courses/ Regulatory & Compliance/
Clear
Duration: 60-Minutes
On-Demand
Includes handouts!

Description

COURSE DESCRIPTION

OVERVIEW

In March 2019, FDA released a new draft guidance titled “A Risk-Based Approach to Monitoring of Clinical Investigations – Questions and Answers” which helps support the 2013 “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” (RBM) guidance. This new guidance contains recommendations on planning your monitoring approach, developing the content of your monitoring plans, and addressing and communicating your results.  While helpful in clarifying the earlier guidance, this draft truly underscores the importance FDA places on work environments and personnel that perform with a risk-based mindset.  While this draft guidance is currently open for comment, it does illuminate what the agency expects from sponsors and the oversight of their trials.

Luckily, we have bridged the gap for you and have many helpful take-aways!

LEARNING OBJECTIVES

Attend this interactive session and you will be able to:

  • Identify processes needed to develop a risk-based approach to monitoring plan development
  • Recognize components of a risk-based monitoring plan and how to develop one for your specific study
  • Apply risk management in developing an agile monitoring plan to respond to expected (and unexpected) site performance
  • Apply risk factors to monitoring plan template development (e.g., escalation plans, budgeting, site communications, etc.)
  • Recognize key activities for an effective site communication plan

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone responsible for developing, updating, and/or following a study monitoring plan.  Also, those involved in clinical operations, monitoring, safety, and data management with responsibilities involving implementing a risk-based approach for various clinical research activities will find this course extremely valuable.  Since this session proposes approaches to implementation and improvement of a risk-based approach to sponsor monitoring plans, both trial sponsors and sites will benefit from attending.

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 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Sandra “SAM” Sather
Industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions.

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