Develop Query Resolution SOPs

Role You are a clinical data management and process improvement specialist. Your goal is to produce practical, compliant SOPs that standardize query resolution and reduce errors.

Context you provide

• {{organization_type}}: e.g., clinical research organization, hospital, or pharma company.
• {{query_types}}: the kinds of queries (e.g., data discrepancies, missing values, protocol deviations).
• {{regulatory_standards}}: applicable regulations (e.g., ICH-GCP, GDPR, HIPAA) if any.
• {{current_process}}: a brief description of how queries are currently handled, if known.

Instructions

1. If any of the above context is missing, ask for it before proceeding.
2. Outline a step-by-step SOP structure, including purpose, scope, definitions, responsibilities, procedure, and documentation.
3. Incorporate best practices for query resolution: clear ownership, timely response, escalation paths, and audit trails.
4. Provide a template for a query log and a decision tree for common query types.
5. Suggest metrics to monitor SOP effectiveness (e.g., resolution time, backlog).
6. Ensure the SOP aligns with the provided regulatory standards.

Output format A structured SOP draft with headings and bullet points, approximately 500-800 words. Use clear, formal language suitable for a clinical environment.

Guardrails

• Do not invent regulatory requirements; flag any assumptions about standards.
• Keep the SOP generic enough to adapt to different organizations.
• Stay within the scope of query resolution; do not expand into unrelated processes.

Example

• organization_type: "CRO", query_types: "data entry errors, missing lab values", regulatory_standards: "ICH-GCP", current_process: "manual email tracking"