Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ On-Demand Courses/ Regulatory & Compliance/
Duration: 90 minutes
On-Demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

The recent update to ICH GCP E6 (R2) has intensified the pursuit of improved monitoring practices that include access to the clinical trial activities sooner in an effort to better manage risk and decrease cost of travel/rework due to noncompliance. This encompasses “smarter” onsite, remote, and centralized monitoring practices. Simply adding centralized and / or remote oversight to a sponsor’s monitoring plan does not equal a risk-based approach or guarantee to improve anything, but is actually more likely to increase risks and damage stakeholder relationships. However, if done correctly, the right blend of onsite, remote, and centralized monitoring can support improved trial outcomes.

Attend this 90-minute interactive webinar to receive a practical guide to implementing an effective monitoring plan.  You’ll find out what required documentation should be in your sponsor/CRO trial master file (TMF) and the most common risks related to Risk-based Monitoring (RBM) you’ll need to mitigate. You’ll also learn the essential skills and training that are needed for monitoring personnel involved in RBM.

LEARNING OBJECTIVES

By attending this interactive live session, you will be able to:

  • Identify various types of monitoring (with and without technology integration) in the post ICH GCP E6 (R2) world
  • Recognize the components of an assessment and implementation plan for a monitoring plan for a specific trial.
  • Discuss the role of the onsite, remote, and centralized monitor; including training needs and oversight (more than the CRA?).

Who Should Attend

WHO SHOULD ATTEND

This course will be valuable to anyone working in clinical trials.  Specifically, this course will be of greatest benefit to those working in clinical operations, clinical quality, and monitoring roles.  Additionally, this session will be of value to senior management and those who work in regulatory affairs, plus anyone who is affected by the quality of trial performance.

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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