Conducting a Virtual GCP Audit of a CRO Managed Study During the COVID-19 Pandemic

Teachers
Michael Pierro
Category:
Clinical Trials & Good Clinical Practices (GCP) Training/ Coronavirus / COVID-19/ On-Demand Courses/ Quality/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90-Minutes
On-Demand
Includes handouts!

Description

COURSE DESCRIPTION

OVERVIEW

Most pharmaceutical and biotech companies (sponsors) outsource the management and conduct of their clinical trials to a Contract Research Organization (CRO).  Although sponsors can delegate tasks to a CRO, they continue to be responsible for subjects’ safety and overall trial compliance to regulatory requirements.  This is a difficult task under normal circumstances, but seemingly impossible under current COVID-19 travel restrictions.  Even with this challenge, global health authorities will still expect sponsors to have complete and uninterrupted oversight of their CRO partners.

The ultimate question remains:  How does a sponsor provide rigorous oversight to ensure protection of subjects’ rights and safety?

This web based training will provide participants with tips and best practices for a conducting a virtual audit of a CRO to determine compliance to Good Clinical Practice (GCP) requirements, study protocols, and CRO/sponsor contractual agreements.

Specifically, this course will cover:

  • Steps in Preparing for the Audit
    • Deciding what & when to audit
    • Set-up Infrastructure (Sponsor & CRO)
    • Properly scheduling the audit
  • Steps in Conducting the Audit
    • Introductions and meetings
    • Documentation to review
    • Questions to Ask
    • Compilation and grading of observations
    • Assessment of
      • Risk to Subject safety and/or study integrity
      • Compliance to GCP/SOP/ Contract(s)
    • The Audit debrief
      • What to say
      • What NOT to say
    • The Audit Report
    • Follow-up activities
    • Audit closure
      • Certificate and File
LEARNING OBJECTIVES

At completion of this training, participants will have a working knowledge of the process for auditing a CRO to determine compliance to GCP and their contractual agreements with the sponsor.  This includes…

  • Examining best practices for preparing for a remote audit
  • Executing steps for conducting a remote audit
  • The audit debrief – what to say, and what not to say
  • Exploring the proper authoring of an audit report
  • Follow-up activities
  • Audit closure

Who Should Attend

WHO SHOULD ATTEND

This training course is designed specifically for Study Monitors, GCP Auditors and other clinical research professionals who perform activities related to auditing clinical studies subcontracted to a CRO.

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

Michael Pierro
Michael Pierro, a highly experienced facilitator and subject matter expert, provides clinical operations and GCP/SOP training to the biotechnology, CRO and pharmaceutical industry.

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