| 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
Regulatory References
- FDA-CFR-002
- ICH-E2C(R2)
- ICH-E2F
- EMA-GVP-004
Instructions
When this skill is activated, Claude should:
- Demonstrate L1 proficiency in submission requirement management
- Apply apply level cognitive skills to apply the topic
- Reference relevant regulatory guidance (FDA-CFR-002, ICH-E2C(R2), ICH-E2F, EMA-GVP-004)
- 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
Generated from PV KSB Framework v1.0 | 2025-12-31
