eCTD Activities – Clinical Data Coordinator (CDM)
As a Clinical Data Coordinator, I support the preparation and submission of clinical data components in compliance with electronic Common Technical Document (eCTD) standards. My responsibilities focus on ensuring data accuracy, regulatory compliance, and timely deliverables.
Key Responsibilities:
Data Preparation & Validation:
Ensure clinical datasets (SDTM/ADaM) are clean, validated, and aligned with CDISC standards before submission.
Example:
Verified SDTM domains (DM, AE) against CRF data.
Cross-checked ADaM datasets with TLF outputs.
Metadata & Documentation:
Prepare and review Define.xml, data specifications, and reviewer guides for regulatory clarity.
Example:
Generated Define.xml with value-level metadata.
Reviewed ADRG and SDRG for consistency.
eCTD Module Support (Module 5):
Assist in organizing and compiling clinical study data for submission-ready format.
Example:
Structured datasets under m5/datasets folder.
Ensured proper naming conventions and file formats.
Quality Control (QC):
Perform QC checks on datasets, annotations, and submission documents to meet regulatory requirements.
Example:
Conducted double-programming validation checks.
Identified and resolved dataset inconsistencies.
Regulatory Compliance:
Ensure all deliverables adhere to guidelines from regulatory authorities like FDA/EMA.
Example:
Ensured CDISC compliance for submission datasets.
Verified adherence to eCTD structure and validation rules.
Collaboration & Communication:
Work closely with biostatistics, programming, and regulatory teams for smooth submission processes.
Example:
Coordinated issue resolution between CDM and SAS teams.
Participated in submission readiness meetings.