Quality Management of Electronic Systems in Clinical Trial Investigations: A Comparison of FDA and EMA Guidance

Teachers
Sandra “SAM” Sather
Category:
Clinical Trials (GCP Training)/ Medical Device Training/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 60-Minutes
On-Demand
Includes Bonus Handouts!

Description

COURSE DESCRIPTION

OVERVIEW

As clinical researchers, we are challenged to fully integrate the management systems needed across functional areas within our electronic systems. Most frequently, the IT group and vendor manage the technology, but software AND process needs to be managed and understood by other cross functional areas when conducting day to day trial activities to support human subject protection and data integrity. This includes pre-study protocol development, vendor and site selection activities, subject safety surveillance, data management, site monitoring, protocol management, project management, and more. 

This webinar presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. The session includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials. 

LEARNING OBJECTIVES

By attending this interactive session, you will be able to…

  • Identify specific quality systems elements to support the use of electronic systems regarding sponsor, site, and IRB/EC regulatory responsibilities
  • Avoid the most common misconceptions related to use of electronic records
  • Recognize the process of ensuring the use of electronic records supports the predicate rules for sponsors, investigators, and IRBs/ECs

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit to anyone working in a GCP regulated or clinical trial environment on global or domestic scale who manages clinical quality management systems (CQMS) at a sponsor, CRO, or site level. This includes personnel in…

  • Quality
  • Clinical Operations
  • Clinical Monitoring
  • Other related functions

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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