IB Summarizer

---

name: ib-summarizer

description: Summarize core safety information from Investigator's Brochures for clinical

researchers

version: 1.0.0

category: Pharma

tags: []

author: AIPOCH

license: MIT

status: Draft

risk_level: Medium

skill_type: Tool/Script

owner: AIPOCH

reviewer: ''

last_updated: '2026-02-06'

---

# IB Summarizer

Description

Summarize core safety information from Investigator's Brochures (IB), helping clinical researchers quickly obtain key drug safety data.

Functions

- Known Adverse Drug Reactions (ADRs) and their incidence rates

- Contraindications

- Warnings and Precautions

- Drug Interactions

- Special population precautions

- Overdose Management

- Important safety updates

Usage

python scripts/main.py <input_file> [options]

Parameters

| Parameter | Type | Default | Required | Description |

|-----------|------|---------|----------|-------------|

| `input_file` | string | - | Yes | IB document path (PDF/Word/TXT) |

| `-o, --output` | string | stdout | No | Output file path |

| `-f, --format` | string | markdown | No | Output format (json, markdown, text) |

| `-l, --language` | string | zh | No | Output language (zh, en) |

Examples

# Basic usage
python scripts/main.py /path/to/IB.pdf

# Output to JSON file
python scripts/main.py /path/to/IB.pdf -o summary.json -f json

# English output
python scripts/main.py /path/to/IB.docx -l en -o summary.md

Output Structure

Markdown Format

# IB Safety Information Summary

## Basic Drug Information
- **Drug Name**: XXX
- **Version**: X.X
- **Date**: YYYY-MM-DD

## Core Safety Information

### Known Adverse Reactions
| System Organ Class | Adverse Reaction | Incidence | Severity |
|-------------|---------|--------|---------|
| ... | ... | ... | ... |

### Contraindications
- ...

### Warnings and Precautions
- ...

### Drug Interactions
- ...

### Special Populations
| Population | Precautions |
|-----|---------|
| Pregnant women | ... |
| Lactating women | ... |
| Children | ... |
| Elderly | ... |
| Hepatic/renal impairment | ... |

### Overdose
- Symptoms: ...
- Management: ...

### Safety Update History
| Version | Date | Update Content |
|-----|------|---------|
| ... | ... | ... |

JSON Format

{
  "drug_info": {
    "name": "Drug Name",
    "version": "Version Number",
    "date": "Date"
  },
  "core_safety_info": {
    "adverse_reactions": [...],
    "contraindications": [...],
    "warnings": [...],
    "drug_interactions": [...],
    "special_populations": {...},
    "overdose": {...},
    "safety_updates": [...]
  }
}

Dependencies

Installation

pip install -r requirements.txt

Notes

1. Input documents should be readable PDF or Word format

2. Scanned PDFs require OCR processing first

3. For complex table structures, manual verification may be needed

4. Information extracted by this tool is for reference only and does not constitute medical advice

Risk Assessment

| Risk Indicator | Assessment | Level |

|----------------|------------|-------|

| Code Execution | Python/R scripts executed locally | Medium |

| Network Access | No external API calls | Low |

| File System Access | Read input files, write output files | Medium |

| Instruction Tampering | Standard prompt guidelines | Low |

| Data Exposure | Output files saved to workspace | Low |

Security Checklist

Prerequisites

# Python dependencies
pip install -r requirements.txt

Evaluation Criteria

Success Metrics

Test Cases

1. **Basic Functionality**: Standard input → Expected output

2. **Edge Case**: Invalid input → Graceful error handling

3. **Performance**: Large dataset → Acceptable processing time

Lifecycle Status

- Performance optimization

- Additional feature support