A demonstration of how functional decomposition and iterative questioning can prevent workslop.

Materials

• National Standard Operating Procedures for Clinical Trials in Australia
• National Statement on Ethical Conduct in Human Research 2025
• ICH E6(R3) Good Clinical Practice Guideline

Task

1. Open Claude or Gemini
2. Attach all three PDF documents to your conversation
3. Paste in the prompt below, then edit your [ROLE] and [SPECIFIC TOPIC]:

Hi Claude.

I work as a [ROLE] at a research institution conducting clinical trials. My goal is to draft a standard operating procedure for [SPECIFIC TOPIC] that complies with Australian regulatory requirements and ICH-GCP.

Before drafting, please:

1. Functionally decompose what makes an effective SOP for this topic
2. Identify relevant requirements from the three attached documents (National Statement, ICH E6(R3), Australian national SOPs)
3. Ask me one specific, pointed, and critical question at a time about my site’s context until you have enough detail to draft a practical SOP

Do not assume—if things are unclear about my site’s procedures, push on the words I use.

To begin, please give me a readback of this task.

1. Answer the AI’s questions until it drafts the SOP

Discussion

• What was your experience?
• What models did you try?
• What questions did it highlight for you to ask?