Data Management Plan (DMP) per ICH E6 + ICH E8(R1) (General Considerations for Clinical Studies) + ICH E9 (Statistical Principles): study database design + EDC system + data capture sources + data collection + data flow + database lock + transfer to statistics + retention; data validation + edit checks + range checks + cross-form checks + medical review + data review committee. External data sources: EHR + Electronic Patient Records + laboratory results + imaging + medical devices + wearables + ePRO + claims + registries; data integration + standardisation + mapping; CDISC standards (CDASH + SDTM + ADaM + SEND + Define-XML) for regulatory submission; data quality + completeness + traceability; data lineage. Real-World Data (RWD) + Real-World Evidence (RWE) per FDA + EMA + Health Canada + PMDA: hybrid + synthetic control arm + external comparator + post-marketing; 21st Century Cures Act + FDA RWE Framework + EMA DARWIN-EU; data quality + fit-for-purpose; pre-specification + protocol alignment. ICH coordination: ICH E8(R1) general considerations + E9 statistical + E10 control groups + E2A safety reporting + E14 (R3) QT prolongation + M4 CTD + M11 CESHARP + M14 RWD + M15 model-informed drug development. International regulator alignment: FDA 21 CFR Part 50/56/312 + EMA EU CTR 536/2014 + EU CTIS + PMDA + Health Canada + Swissmedic + ANVISA + Anvisa + NMPA China + CDSCO India + national CROs. 2024-2025 pipeline: artificial intelligence + machine learning for clinical trials (FDA AI/ML Action Plan + EMA Reflection Paper + ICH guidance); decentralised + hybrid + adaptive + master protocol + platform trials + tokenisation. ICH E6 + Data Management + External Data + RWE + International Coordination applies.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.