ksb-d07-k0031

name	KSB-D07-K0031
description	Submission Requirement Management: Country-specific timelines, data element requirements, follow-up obligations, exemption criteria...
version	1.0.0
domain	D07
domain_name	Spontaneous Reporting Systems
type	Knowledge
proficiency_level	L1
bloom_level	apply
triggers	["explain submission requirement management","what is submission requirement management","apply submission requirement management"]
epa_mapping	EPA-02, EPA-04, EPA-05
cpa_mapping	CPA-02, CPA-05
regulatory_refs	FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004

KSB-D07-K0031: Submission Requirement Management

Overview

Domain: D07 - Spontaneous Reporting Systems Type: Knowledge Proficiency Level: L1 (Novice - Direct supervision required) Bloom Level: Apply

Description

Country-specific timelines, data element requirements, follow-up obligations, exemption criteria

Context

• Major Section: Global Spontaneous Reporting System Architecture
• Section: Global Regulatory Framework Navigation

EPA Mapping

• EPA-02:3004-3005
• EPA-04:3009-3010
• EPA-05:3011-3012

CPA Pathway

• CPA-02, CPA-05

Regulatory References

• FDA-CFR-002
• ICH-E2C(R2)
• ICH-E2F
• EMA-GVP-004

Instructions

When this skill is activated, Claude should:

1. Demonstrate L1 proficiency in submission requirement management
2. Apply apply level cognitive skills to apply the topic
3. Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
4. Connect to related EPAs: EPA-02, EPA-04, EPA-05

Key Competencies

• Country-specific timelines, data element requirements, follow-up obligations, exemption criteria

Assessment Criteria

• Can apply core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D07 skills in Global Regulatory Framework Navigation
• Cross-domain integrations per DAG architecture

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Generated from PV KSB Framework v1.0 | 2025-12-31