MODULE TITLE
Purple Sheep CPE™ — Institutional Compliance & Control Systems Series™ (Audit) Module 5: Institutional Risk Mapping Across Sponsored Programs
PROGRAM IDENTIFICATION
Purple Sheep CPE™
Institutional Compliance & Control Systems Series™ (Audit)
1.0 CPE Contact Hour | Self-Paced Professional Education
MODULE OVERVIEW
Risk is not evenly distributed. It is concentrated.
Institutional exposure does not originate from a single function or isolated breakdown. It emerges across decentralized environments, including central offices, departments, subrecipients, and operational units. Without structured visibility, institutions are unable to identify where risk is concentrated or how it propagates across systems.
This module provides a structured, risk-based examination of institutional risk mapping within sponsored programs. It focuses on identifying, visualizing, and prioritizing exposure across organizational structures to support informed decision-making and control system strengthening.
Institutional exposure rises when risk is evaluated in isolation rather than as part of a connected institutional system. These weaknesses create recurring risk because control failures may exist across multiple units without a coordinated understanding of their cumulative impact.
KEY AREAS OF FOCUS
This module examines:
• Foundations of institutional risk mapping within sponsored environments
• Centralized and decentralized models of risk exposure
• Department-level and operational risk concentration
• Subrecipient and third-party exposure mapping
• Building institutional risk visibility and prioritization frameworks
These areas define how institutions identify where risk exists and how it should be addressed.
PROGRAM STRUCTURE & INSTRUCTIONAL DESIGN
This module is structured to reinforce enterprise-level visibility and strategic control system alignment.
The module includes:
• Scenario-based analysis reflecting cross-unit exposure and risk concentration
• Structured evaluation of institutional risk distribution patterns
• Applied learning activities designed to assess risk visibility and prioritization
• Knowledge validation through formal assessment
Topic structure follows the standardized Purple Sheep CPE™ model, including required engagement activities and a formal knowledge check to support audit defensibility.
REGULATORY & COMPLIANCE ALIGNMENT
This module aligns with established regulatory and internal control frameworks, including:
• 2 CFR 200 (Uniform Guidance)
• ICH Good Clinical Practice (E6)
• Applicable FDA regulations governing sponsored and clinical activity
• COSO Internal Control Framework principles
Content reflects how institutional risk is evaluated across organizational systems within audit environments.
LEARNING OBJECTIVES
Upon completion of this module, participants will be able to:
• Evaluate institutional exposure across decentralized and centralized environments
• Assess how risk is distributed and concentrated within institutional systems
• Analyze operational units and subrecipient structures for exposure patterns
• Identify areas of high-risk concentration requiring prioritized attention
• Determine whether institutional visibility supports effective risk management
• Apply governance-based approaches to institutional risk mapping and prioritization
COMPLETION & AUDIT VERIFICATION
Completion of this module requires:
• Full review of all instructional content
• Completion of required engagement activities
• Successful completion of the knowledge check assessment
Participant progression and completion data are recorded to support institutional documentation and audit verification requirements.
SERIES CONTINUITY
This module builds on audit findings by defining where institutional exposure exists across the research enterprise.
It directly supports the final module addressing:
• Control culture, leadership tone, and recurring failure patterns
This module defines where risk lives before examining why it persists.
CPE STATEMENT
This module, combined with required engagement activities, represents 1.0 CPE contact hour.
CREDENTIAL ALIGNMENT
This module is designed to support continuing education and professional development aligned with:
• Research Administrators Certification Council (RACC) expectations (CRA, CPRA, CFRA)
• Clinical research compliance and certification domains, including the Certified Clinical Research Professional (CCRP) credential administered by the Society of Clinical Research Associates (SOCRA)
• Clinical research competencies aligned with ACRP certification frameworks
• Internal audit and compliance competencies aligned with CIA principles
Module Access & Availability
Access to individual modules is provided for 90 days from the date of enrollment.
Individual modules are offered as part of the initial launch phase through December 31, 2026. Beginning January 2027, Purple Sheep CPE™ will transition to a series-based model designed to support deeper learning, stronger outcomes, and institutional alignment.
Audit readiness is not a reactive event — it is an operational posture.
Institutions that prepare in advance reduce the risk of escalation, limit expanded sampling, and strengthen defensibility during review.
This module examines:
• What auditors evaluate • Documentation preparation strategies • Staff role clarity during audit engagement • Pre-audit internal review processes • 30-day readiness planning
Participants will develop a practical, proactive framework for audit preparation.
Estimated Instructional Time: 60 minutes (1.0 Contact Hour)
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