Just in Time GCP

Clinical Study Data Flow Maps

Practical guidance for trial sponsors navigating data integrity, traceability, and sponsor oversight in the ICH E6(R3) era.

Free Webinar | Wednesday, September 23, 2026 | 11 AM - 12:30 PM ET | Live and On-Demand Access

Promotional graphic for a free webinar titled "Clinical Study Data Flow Maps." The title appears in large blue text with a green data flow and systems icon integrated into the words. Supporting text reads "Free Webinar" on the left and "Includes Starter Kit" on the right. A blue banner across the bottom displays the event details: "Sept 23 | 11 AM - 12:30 PM ET." The design uses Just in Time GCP brand colors of blue and green on a light gray background.

As organizations operationalize ICH E6(R3), sponsors are increasingly being asked to explain how study data moves across systems, vendors, and functions. Regulatory investigators are placing greater emphasis on data integrity, traceability, and sponsor oversight, creating new expectations for understanding and documenting the clinical data lifecycle.

This webinar explores how Clinical Study Data Flow Maps can help sponsors build a clear, defensible understanding of their data ecosystem. Participants will learn practical approaches for defining scope, identifying critical data pathways, establishing ownership, and developing data flow maps that support oversight, traceability, and inspection readiness.

Click Here to Register

Page Sections

What to Expect

This 90-minute webinar combines industry benchmarking, practical implementation guidance, and real-world sponsor experience. The session begins with insights we’ve collected from trial sponsors highlighting current challenges, regulatory pressures, and common gaps related to Clinical Study Data Flow Maps, followed by a practical presentation on developing and maintaining data flow maps that support traceability, oversight, and inspection readiness.

The second half of the session features a sponsor panel sharing lessons learned from inspection preparation and regulatory requests for data flow maps, followed by a live Q&A. Full session details are outlined in the agenda below.

Understand Why Clinical Study Data Flow Maps Are Becoming an Inspection Conversation

What You'll Learn

  • Why Clinical Study Data Flow Maps are receiving increased regulatory attention
  • How to determine what should and should not be included in your map
  • How to identify critical systems, vendors, and data transfer pathways across the study lifecycle
  • What level of detail supports traceability without creating unnecessary complexity
  • How to establish ownership, governance, and maintenance responsibilities
  • How to use data flow maps to support sponsor oversight and inspection readiness
FDA/MHRA/Health Canada All Signal Growing Focus on Data Governance and Flows

Who Should Attend

This webinar is designed exclusively for trial sponsors responsible for clinical data oversight, inspection readiness, and cross-functional study management, including:

  • Clinical Operations professionals
  • Clinical Data Management professionals
  • Quality and GCP professionals
  • Clinical Systems and Technology leaders
  • TMF and Clinical Documentation professionals
  • Study and Trial Management teams
  • Sponsor teams overseeing CROs, vendors, and service providers
Read Clinical Leader Article by Donna Dorozinsky — Inspection Readiness Breaks Down When You Can't Trace the Data

Agenda - Wednesday, September 23

11:00 AM ET

INTRODUCTION

What Sponsors Told Us: Insights from Webinar Registration Data

  • Where are sponsors in their Clinical Study Data Flow Map journey?
  • What challenges are organizations facing today?
  • Which systems, vendors, and data flows create the most uncertainty?
  • How do attendee experiences compare to current regulatory expectations?

11:10 AM ET

PRESENTATION

Clinical Study Data Flow Maps: From Regulatory Expectations to Practical Implementation

Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP

  • Determine what should and should not be included in your Clinical Study Data Flow Map
  • Define scope, ownership, and governance across systems and vendors
  • Capture critical data flows and points of transformation throughout the study lifecycle
  • Engage the right stakeholders to build and maintain an accurate map
  • Use data flow maps to support traceability, oversight, and inspection readiness

11:40 AM ET

PANEL DISCUSSION

Beyond the Diagram: What Sponsors Learned When Regulators Asked About Data Flow

Experts share firsthand experiences responding to regulatory requests for data flow maps—what approaches worked well, what challenges they faced, and what they’d do differently next time.

Moderator
Donna Dorozinsky, Founder & CEO, JUST IN TIME GCP

Panelists
TBD

  • What triggered organizations to prioritize Clinical Study Data Flow Maps
  • The realities of preparing for regulatory questions about data flow and traceability
  • Navigating complexity across systems, vendors, and data transfers
  • Building sustainable processes that remain accurate as studies evolve
  • The biggest surprises, lessons learned, and advice sponsors would give their peers

12:20 PM ET

LIVE AND UNFILTERED: SPEAKER Q&A SESSION
(Not Recorded—Must Attend Live)

Get face-to-face (virtually) with the previous speakers in an exclusive, live-only Q&A. This is your chance to ask the real questions—the ones you’ve been dying to ask but never see on a slide.

No slides, recordings or judgment. Just candid conversation, behind-the-scenes insights, and the space to dig into what really matters.

12:30 PM ET

WEBINAR ENDS — On-Demand Version Available for 30 Days

What Registration Includes

  • Live participation in the 90-minute live webinar on Clinical Study Data Flow Maps
    • Includes expert presentation, moderated panel discussion, and live Q&A
  • Insight from anonymized participant data showing how sponsors compare across confidence, experience, and approaches
  • 30-day access to the on-demand recording (presentation and panel discussion; live Q&A excluded)
  • Clinical Study Data Flow Mapping Starter Kit, a practical guidance, worksheets, and implementation tool for trial sponsors, sent post webinar
  • Presentation Slides from the webinar, sent post webinar
Click Here to Register - Free for Trial Sponsors

Clinical Study Data Flow Starter Kit - Included with Registration

A practical resource designed to help trial sponsors begin documenting and understanding their study data lifecycle, including:

✔ Regulatory expectations and inspection considerations

✔ Sample checklists and first-step planning tools

✔ Guidance on identifying systems, data origins, transfers, and transformations

✔ Cross-functional interview questions and discussion prompts

✔ Common pitfalls and lessons learned from industry experience

✔ Examples of what effective Clinical Study Data Flow Maps demonstrate

How Just in Time GCP Can Help

Just in Time GCP helps trial sponsors translate early data flow mapping efforts into inspection-ready lifecycle documentation through:

  • Full-study or multi-study data lifecycle mapping
  • Cross-functional R3 alignment workshops
  • Vendor oversight process optimization
  • TMF-integrated data traceability frameworks
  • Inspection readiness preparation specific to data lifecycle controls
  • Technical + operational harmonization across systems
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