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Data Protection

Designed an enterprise-wide data protection solution that drove measurable risk reduction and CAPA closure in a regulated clinical environment.

Project Details

Project Name

Subject Confidentiality Training Program

Tools Used

Articulate Storyline 360 · LMS (SCORM 2004 3rd Edition) · Excel (data analysis & pivot tables)

Skills Applied

​Learning Needs Analysis · Root Cause Analysis · Compliance Training Design · Assessment Design · Scenario-Based Learning · Data Analysis · Stakeholder Interviews · CAPA Support

Project Overview

This project focused on improving enterprise-wide handling of subject data and Personally Identifiable Information (PII) within a highly regulated clinical environment. Prior to this initiative, there was no comprehensive training program addressing subject confidentiality—only a basic Read & Acknowledge activity tied to a standard operating procedure (SOP).​As part of a broader Corrective and Preventive Action (CAPA) effort, I designed and delivered a three-part, scalable learning solution for a global audience of 30,000+ learners, combining awareness, application, and assessment to drive measurable behavior change.

My Role

  • Led end-to-end learning strategy, analysis, and design for an enterprise-wide compliance initiative

  • Conducted data analysis across three QA systems to identify trends, risks, and root causes

  • Partnered with Legal, Quality, Clinical Operations, and executive sponsors to align remediation strategy

  • Designed and built a multi-part Storyline 360 solution, including a large-scale, randomized assessment

  • Defined evaluation approach and analyzed post-training outcomes to support CAPA closure

Business Challenge

The organization was experiencing frequent and repeat data security/privacy breaches, including minor, major, and critical quality events related to subject confidentiality. These events were captured across multiple quality systems and spanned regions, vendors, and functional areas.

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Key challenges included:

  • No enterprise-wide training addressing real-world data handling scenarios

  • Limited insight into why breaches were occurring or recurring

  • Ineffective post-event remediation that failed to prevent repeat incidents

  • A live CAPA requiring defensible evidence of corrective action and impact

 

The business needed a solution that went beyond policy acknowledgment and demonstrably reduced risk.

Strategic Solution

I began with a three-month discovery and analysis phase to identify both knowledge and behavior gaps:

  • Reviewed all CAPA documentation and remediation requirements

  • Analyzed 18 months of clinical quality events across three QA systems, identifying patterns by event severity, source, and data type

  • Conducted cross-functional stakeholder interviews (Legal, Quality Assurance, Pharmacovigilance, Clinical Operations, Business Optimization)

  • Used Lean Six Sigma root cause analysis tools to understand why breaches were occurring and why existing controls were ineffective

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Based on these findings, I proposed and designed a multi-pronged remediation strategy, anchored by a three-part course built in Storyline 360:

  1. Short animated video to establish context and reinforce risk awareness

  2. Interactive SOP review with required download for daily reference

  3. Comprehensive, scenario-based assessment using real-world data breach examples

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The assessment was a critical component. It included:

  • Multiple randomized question banks to support retakes and reduce answer-sharing

  • Graphics-heavy questions reflecting real patient records and documentation

  • Diverse interaction types (hotspot, drag-and-drop, scenario-based, multiple choice)

  • Targeted feedback for both correct and incorrect responses

  • LMS-level response tracking to support remediation and CAPA reporting

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In parallel, I supported the rollout with:

  • Structured manager follow-up for repeated failed attempts

  • Coaching recommendations for post-event remediation

  • Executive-sponsored communication to address regional findings and reduce resistance

Course Walk-through

In order to protect the confidentiality of the original project, I have elected to provide a screenshot walk-through of the course, which includes all of the intro and wrap-up slides as well as a selection of the question types.

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As noted above, the assessment draws from three different question pools, allowing randomization for multiple attempts. The course is designed to reinforce desired behavior—that is, a learner downloads the SOP and works through challenging questions as they would be expected to when faced with situations at work.

Before & After

Before the Intervention

  • Subject confidentiality training was limited to a policy acknowledgment activity

  • Learners lacked exposure to realistic, role-based data handling scenarios

  • Privacy breaches recurred across regions and functional areas

  • Post-event remediation efforts were inconsistent and ineffective

 

After the Intervention

  • Learners demonstrated improved ability to identify and respond to real-world data privacy risks

  • Minor quality events decreased and major/critical events were eliminated within 90 days

  • Post-training data supported successful CAPA closure

  • A repeatable framework for remediation and follow-up was established

Results & Impact

The program delivered clear, measurable outcomes tied directly to CAPA objectives.​

This project demonstrated how targeted learning design—grounded in data analysis, stakeholder insight, and realistic assessment—can drive meaningful risk reduction at scale.

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