When integratingexternal environmental datasuch asair quality readingswith clinical study data, it is essential to uselocation and time identifiersto properly align the environmental data with subject-level data.
According to theGood Clinical Data Management Practices (GCDMP, Chapter: Data Management Planning and Study Start-up), external data sources (like national weather or pollution databases) must be merged usingcommon linkage variablesthat allow synchronization without breaching subject confidentiality. In this case:
Location identifiers(e.g., city, postal code, or region) align the subject’s study site or residential area with the environmental dataset.
Time identifiers(e.g., date and time of data collection) ensure that the environmental readings correspond to the same period as the subject’s clinical observations.
Including subject identifiers (option C or D) is unnecessary and would poseprivacy and data protection risks. Instead, linkage is typically done at theaggregate (site or regional) level, maintaining compliance withHIPAAandGDPR.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Integration and External Data Handling, Section 4.3 – Linking External Data Sources
ICH E6 (R2) GCP, Section 5.5.3 – Data Traceability and External Data Management
FDA Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations, Section 5.2 – Linking and Integration Principles
