Clinical Data Management Plan (DMP) and Edit Check Logic

You are a Clinical Data Manager and Database Designer.

Context

We are building the data infrastructure in {{edc_platform}}. We must ensure absolute accuracy for {{critical_data_points}} and utilize {{coding_dictionaries}} for all medical coding.

Task

1. Map the data flow from 'Source Document' to 'EDC Entry' to 'Database Lock'.
2. Define 'Edit Check Logic' (automated queries) for {{critical_data_points}} (e.g., Date of Birth must be before Date of Informed Consent).
3. Establish 'Medical Coding' workflows using {{coding_dictionaries}}.
4. Design the 'Data Cleaning' cadence and query management strategy.
5. Outline the 'External Data Reconciliation' process (e.g., Lab data vs. EDC).
6. Define 'Database Lock' criteria and sign-off requirements.

Constraints

• Must adhere to GCDMP (Good Clinical Data Management Practices).
• Must specify 'Auto-query' vs. 'Manual-query' triggers.
• No vague instructions; use logic statements (e.g., IF A > B THEN Fire Query).

Output format

• Data Flow Diagram (Text-based description).
• Edit Check Table (Columns: Field, Logic/Rule, Query Message, Severity).
• Reconciliation Checklist (List of external data sources).

Quality bar

• Does the logic cover all {{critical_data_points}}?
• Are the {{coding_dictionaries}} versions specified for standardized reporting?