Purple Sheep CPE™

MODULE TITLE

Purple Sheep CPE™ — Post-Award Financial Stewardship (Post-Award) Module 5: Award Modification Governance & Compliance Controls

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PROGRAM IDENTIFICATION

Purple Sheep CPE™
Post-Award Financial Stewardship (Post-Award) Series™
1.0 CPE Contact Hour | Self-Paced Professional Education

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MODULE OVERVIEW

Post-award modifications do not adjust activity. They alter institutional risk.

Changes to budgets, timelines, scope of work, personnel commitments, and subrecipient structures directly impact the financial, regulatory, and operational posture of an award. These changes require structured governance to ensure that institutional obligations remain aligned with sponsor expectations.

This module provides a structured, risk-based examination of award modification governance within institutional environments. It focuses on how institutions evaluate, approve, document, and monitor changes while maintaining compliance and control system integrity.

Institutional exposure rises when modifications are implemented without formal evaluation, approval authority is unclear, or documentation fails to capture the impact of change. These weaknesses create recurring risk because altered conditions may invalidate prior assumptions, controls, and compliance positions.

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KEY AREAS OF FOCUS

This module examines:

• Award modification governance frameworks within institutional environments
• Evaluation of changes to budgets, timelines, scope, and personnel
• Approval structures and decision authority for modifications
• Documentation and monitoring of post-award changes
• Ensuring compliance through structured change management

These areas represent dynamic control points where institutional stability is either maintained or compromised.

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PROGRAM STRUCTURE & INSTRUCTIONAL DESIGN

This module is structured to reinforce governance under conditions of change.

The module includes:

• Scenario-based analysis reflecting real modification-related compliance failures
• Structured evaluation of approval gaps and undocumented changes
• Applied learning activities designed to assess modification governance strength
• Knowledge validation through formal assessment

Topic structure follows the standardized Purple Sheep CPE™ model, including required engagement activities and a formal knowledge assessment to support audit defensibility.

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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 post-award changes are evaluated within institutional and sponsor oversight environments.

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LEARNING OBJECTIVES

Upon completion of this module, participants will be able to:

• Evaluate institutional exposure created through unmanaged or undocumented modifications
• Assess whether approval structures support controlled decision-making
• Analyze the impact of changes on financial, regulatory, and operational conditions
• Identify documentation gaps that weaken modification defensibility
• Determine whether monitoring systems adapt to evolving award conditions
• Apply governance-based approaches to strengthening modification control systems

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COMPLETION & AUDIT VERIFICATION

Completion of this module requires:

• Full review of all instructional content
• Completion of required engagement activities
• Successful completion of the knowledge assessment

Participant progression and completion data are recorded to support institutional documentation and audit verification requirements.

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SERIES CONTINUITY

This module builds on labor control systems by examining how institutional oversight is maintained when award conditions change.

It directly supports the final module addressing:

• Closeout as control verification

The strength of modification governance determines whether institutional control systems remain stable under changing conditions.

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CPE STATEMENT

This module, combined with required engagement activities, represents 1.0 CPE contact hour.

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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.