| name | KSB-D07-K0002 |
| description | ICH E2B Standards: Electronic transmission requirements, message format specifications, data element definitions, valid... |
| version | 1.0.0 |
| domain | D07 |
| domain_name | Spontaneous Reporting Systems |
| type | Knowledge |
| proficiency_level | L1 |
| bloom_level | understand |
| triggers | ["explain ich e2b standards","what is ich e2b standards","explain ich e2b standards"] |
| 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-K0002: ICH E2B Standards
Overview
Domain: D07 - Spontaneous Reporting Systems
Type: Knowledge
Proficiency Level: L1 (Novice - Direct supervision required)
Bloom Level: Understand
Description
Electronic transmission requirements, message format specifications, data element definitions, validation rules
Context
- Major Section: Global Spontaneous Reporting System Architecture
- Section: International Reporting Framework Integration
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 ich e2b standards
- Apply understand level cognitive skills to explain 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
- Electronic transmission requirements, message format specifications, data element definitions, validation rules
Assessment Criteria
- Can explain core concepts independently
- Demonstrates understanding of regulatory context
- Applies knowledge appropriately to PV scenarios
Related Skills
- Other D07 skills in International Reporting Framework Integration
- Cross-domain integrations per DAG architecture
Generated from PV KSB Framework v1.0 | 2025-12-31
