Protocol Parsing Skill

Purpose

Extract structured metadata from clinical trial protocol documents (PDF format).

Input

• •Protocol PDF document
• •Study identifier (if known)

Output Schema

{
  "study_id": "string",
  "study_title": "string",
  "sponsor": "string",
  "phase": "string (I, II, III, IV)",
  "indication": "string",
  "objectives": {
    "primary": "string",
    "secondary": ["string"]
  },
  "treatment_arms": [
    {
      "name": "string",
      "description": "string",
      "dose": "string (optional)"
    }
  ],
  "key_inclusion_criteria": ["string"],
  "key_exclusion_criteria": ["string"],
  "planned_enrollment": "number",
  "study_duration": "string"
}

Extraction Instructions

Study Identification

1. •Look for "Protocol Number" or "Study ID" in header/title page
2. •Extract sponsor name from cover page
3. •Identify phase from title or objectives section

Objectives

1. •Locate "Objectives" or "Study Objectives" section
2. •Primary objective is typically first, marked explicitly
3. •Secondary objectives follow, may be numbered

Treatment Arms

1. •Find "Study Design" or "Treatment" section
2. •Look for tables showing arm descriptions
3. •Extract dose, route, frequency information

Inclusion/Exclusion Criteria

1. •Locate "Eligibility Criteria" section
2. •Key criteria often marked with asterisks or bold
3. •Prioritize age, diagnosis, disease stage criteria

Schedule of Activities

1. •Identify table format in "Study Procedures" section
2. •Extract visit names, timing, and procedures
3. •Note visit windows if specified

Example Prompts

For Cover Page Analysis

Extract the study ID, sponsor name, phase, and study title from this protocol cover page.

For Objectives Section

Identify the primary and secondary objectives from this section.
The primary objective typically mentions the main efficacy endpoint.

For Treatment Arms

List all treatment arms including placebo. For each arm, extract:
- Arm name
- Drug/intervention
- Dose and frequency
- Route of administration

Validation Rules

• •Study ID should match expected format (sponsor prefix + number)
• •Phase should be I, II, III, or IV
• •At least one treatment arm required
• •Primary objective must be present