Course Description
Led by Jon Prigge, Ph.D., Clinical Quality Leader and Data Integrity & GxP Compliance Specialist, this training emphasizes systems-based thinking and practical application. Participants will learn how effective quality system design supports reliable data, inspection readiness, and patient safety—particularly within hybrid paper and electronic environments that continue to challenge modern clinical operations.
The course places Data Integrity at the center of clinical validity, moving beyond checklist compliance and “human error” narratives to examine systemic contributors to quality outcomes. Through instructor-led discussion and interactive exercises, attendees will strengthen their ability to identify quality vulnerabilities, evaluate documentation integrity, and apply proportionate oversight strategies across global clinical trials.
By the conclusion of the training, participants will have a clearer understanding of how QMS design, Data Integrity, and risk-aware oversight intersect in real-world clinical research—and how to translate regulatory expectations into sustainable, inspection-ready practices.
Course at a Glance
2-Day Live Virtual Workshop
2 Full Days of Interactive Learning
Intensive, instructor-led sessions
July 15-16,2026
Upcoming Virtual Workhop
9:00 AM - 4:00 PM EST
Small-group, live instructor-led sessions
Price : $1995.00 USD
Location:
Participate from anywhere with stable internet
Certificate of Completion from CRTA
Recognized professional credential
Faculty Director: Jon Prigge
Limited Seats - Secure Your Spot Early!
Learning Objectives
By the end of this course, participants will be able to:
-
•
Apply systems-based quality thinking to strengthen QMS design and oversight for IMPs
-
•
Identify and address Data Integrity vulnerabilities across paper, hybrid, and electronic environments
-
•
Move beyond “human error” to evaluate systemic contributors to clinical quality issues
-
•
Apply proportionate, risk-aware oversight strategies aligned with ICH E6(R3)
-
•
Strengthen audit and inspection readiness through improved documentation integrity and technical compliance
Who Should Attend
-
•
Quality Assurance and Quality Control professionals supporting clinical trials
-
•
Clinical Research Associates and Clinical Research Coordinators
-
•
Scientific Leads and Principal Investigators
-
•
Regulatory Affairs professionals
-
•
Clinical Operations team members
-
•
Project Managers and Clinical Trial Managers
-
•
Professionals preparing for audits/inspections, or expanded quality oversight responsibilities
Course Outline
Course Modules
Module 1
Clinical quality foundations and the evolving regulatory landscape
Module 2
Quality oversight across the technical lifecycle of the IMP
Module 3
Data Integrity in practice: ALCOA+, hybrid systems, and documentation integrity
Module 4
Core components of an effective and scalable clinical QMS
Module 5
Quality risk thinking and proportionate oversight strategies aligned with ICH E6(R3)
Module 6
Moving beyond human error: identifying systemic contributors to quality issues
Module 7
Audit and inspection readiness in remote, digital, and hybrid environments
The course progresses from regulatory and system fundamentals to applied decision-making and inspection-focused considerations, reinforcing how quality concepts translate into real-world clinical oversight.
Interactive Activities
This course features live, instructor led interactive activities designed to reinforce key concepts and support real world application of clinical quality and Data Integrity principles. Activities emphasize critical thinking, scenario analysis, and systems based evaluation, rather than prescriptive or tool driven exercises.
Planned activities include:
- •
Data Integrity & Hybrid Systems Analysis: Participants will examine realistic clinical workflows that span paper, hybrid, and electronic environments to identify where Data Integrity may be compromised and how system design influences data reliability.
- •
Systemic Quality Gap Identification: Through applied quality scenarios, participants will practice identifying system-level contributors to GxP issues, focusing on process design, oversight models, and cross-functional interfaces rather than “human error.”
- •
Proportionate Oversight Decision Scenarios: Participants will evaluate oversight approaches aligned with ICH E6(R3), discussing how to apply proportionate, risk-aware quality strategies in complex and resource-constrained clinical settings.
The course concludes with a facilitated synthesis discussion, connecting QMS design, Data Integrity, and inspection readiness to reinforce how these concepts work together in realworld clinical operations.
