Clinical Trial Protocol Startup Welcome And Mode Selection

Startup: Welcome and Mode Selection (+1)

Startup: Welcome and Mode Selection

When skill is invoked, display the following message:

CLINICAL TRIAL PROTOCOL

Welcome! This skill generates clinical trial protocols for medical devices or drugs.

[If waypoints/intervention_metadata.json exists:]
Found existing protocol in progress: [Intervention Name]
  Type: [Device/Drug]
  Completed: [List of completed steps]
  Next: [Next step to execute]

SELECT MODE:

1. Research Only - Run clinical research analysis (Steps 0-1)
   - Collect intervention information
   - Research similar clinical trials
   - Find FDA guidance and regulatory pathways
   - Generate comprehensive research summary as .md artifact

2. Full Protocol - Generate complete clinical trial protocol (Steps 0-5)
   - Everything in Research Only, plus:
   - Generate all protocol sections
   - Create professional protocol document

3. Exit

Please select an option (1, 2, or 3):

STOP and WAIT for user selection (1, 2, or 3)

• If 1 (Research Only): Set execution_mode = "research_only" and proceed to Research Only Workflow Logic
• If 2 (Full Protocol): Set execution_mode = "full_protocol" and proceed to Full Workflow Logic
• If 3 (Exit): Exit gracefully with "No problem! Restart the skill anytime to continue."

Research Only Workflow Logic

This workflow executes only Steps 0 and 1, then generates a formatted research summary artifact.

Step 1: Check for Existing Waypoints

• If waypoints/intervention_metadata.json exists: Load metadata, check if steps 0 and 1 are already complete
• If no metadata exists: Start from Step 0

Step 2: Execute Research Steps (0 and 1)

For each step (0, 1):

1. Check completion status: If step already completed in metadata, skip with "Step [X] already complete"

2. Execute step:

   • Display "Executing Step [X]..."
   • Read and follow the corresponding subskill file instructions
   • Wait for completion
   • Display "Step [X] complete"
   • Step execution method (ON-DEMAND LOADING): When a step is ready to execute (NOT before), read the subskill markdown file and execute ALL instructions within it
   • Step-to-file mapping:
     • Step 0: references/00-initialize-intervention.md (collect intervention info)
     • Step 1: references/01-research-protocols.md (clinical research and FDA guidance)

3. Handle errors: If step fails, ask user to retry or exit. Save current state for resume capability.

Step 3: Generate Research Summary Artifact

After Step 1 completes successfully:

1. Read waypoint files:

   • waypoints/intervention_metadata.json (intervention details)
   • waypoints/01_clinical_research_summary.json (research findings)

2. Create formatted markdown summary: Generate a comprehensive, well-formatted research summary as a markdown artifact with the following structure:

# Clinical Research Summary: [Intervention Name]