This project demonstrates the design and implementation of an automated pipeline to map heterogeneous clinical trial source datasets into the CDISC-compliant Study Data Tabulation Model (SDTM) DM (Demographics) domain. Using a specification-driven approach, raw data from multiple files (DM_IN, Disposition, Informed Consent, Randomization, Trial Arms) are ingested, harmonized, and transformed according to predefined rules for variable naming, derivations, and controlled terminology. Key processes include automated generation of USUBJID keys, standardized ISO 8601 date conversion, demographic and treatment-arm assignment, and metadata application using SDTM-compliant labels, lengths, and formats. The resulting DM dataset is exportable in XPT, CSV, Excel, and SQL formats, ready for regulatory submission or integration with other domains. In practice, this automated framework significantly reduces manual programming effort and QC time compared to traditional study-by-study SDTM programming, enabling consistent, auditable, and rapid DM domain preparation.
Clinical trial data from multiple systems must be standardized to CDISC’s Study Data Tabulation Model (SDTM). This project implemented a repeatable, automated pipeline that ingests heterogeneous raw datasets and produces a validated, submission-ready SDTM DM (Demographics) domain.
| Step | Action |
|---|---|
|
1. Create USUBJID |
Derived in each dataset: `’ABC-400′ |
|
2. Sort Datasets |
All datasets sorted by USUBJID for consistent merging. |
|
3. Merge Core Datasets |
DM_IN, DS, INCO, and RAND merged on USUBJID. |
|
4. Date Handling |
Converted FIRSTDT to numeric then formatted to ISO 8601 (YYYY-MM-DD) to derive RFSTDTC. |
|
5. Arm Assignment Merge |
In RD, renamed R_ARM to ARMCD. Sorted RD and TA by ARMCD, merged to pull ARMCD and ARM. Then merged arm data into DM by USUBJID. |
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6. Variable Retention & Labeling |
Rearrange variables as per DM domain specification |
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7. Race Recoding |
Map numeric race codes to SDTM controlled terms and rename back to RACE |
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8. Output Dataset
|
Created final DM with all required and expected variables with specified attributes. |
| Transformation | Description |
|---|---|
|
Dates |
All date variables converted to ISO 8601 (YYYY-MM-DD). |
|
Age |
Derived from BRTHDTC and RFSTDTC; AGEU set to “YEARS” |
|
Sex & Race |
Mapped numeric codes to controlled SDTM text values. |
|
Treatment Arms |
Extract ARMCD and ARM from RD + TA merge; mirrored into ACTARMCD / ACTARM |
|
Country & Defaults |
COUNTRY set to “USA”; DTHDTC and DTHFL left null; ETHNIC set to “NOT REPORTED” |
| Challenges | Resolution |
|---|---|
|
Different source file formats / column names |
Wrote generic loader and header-cleaning functions. |
|
Non-standard date formats |
Built parse_date_safe() function with robust ISO 8601 conversion. |
|
Missing or inconsistent race/sex codes |
Created explicit mapping function to controlled SDTM terms. |
|
Arm assignment split across RD and TA |
Automated RD+TA merge by ARMCD before merging with DM. |
|
Ordering and metadata compliance |
Used retain-order lists and applied labels/lengths via Python metadata mapping |
| Aspect | Manual Approach | Automated Approach |
|---|---|---|
|
Variable mapping & derivations |
Several days per study to write SAS code manually |
Central JSON/spec + Python/SAS engine executes in minutes |
|
QC of date formats & controlled terms |
Manual review across datasets |
Built-in conversion & recoding functions ensure uniformity automatically |
|
Combining arm data & demographics |
Manual joins with multiple intermediate datasets |
Automated RD+TA merge and single pass integration |
| Deliverable | Description |
|---|---|
|
Python Scripts |
Implement data ingestion, transformation, mapping, and export |
|
SDTM DM Dataset |
Standardized DM dataset exportable to CSV, Excel, SQL |
|
Process Documentation |
Structured, auditable workflow reusable across studies |
The SDTM Project 1 successfully demonstrates the automation of mapping heterogeneous clinical trial datasets into a CDISC-compliant SDTM DM (Demographics) domain. Using a specification-driven pipeline, raw data from multiple sources were ingested, harmonized, and transformed with standardized variable naming, controlled terminology, and ISO 8601 date formats. Automated processes, including USUBJID generation, arm assignment merges, and demographic derivations, ensured consistency, traceability, and regulatory compliance across the resulting DM datasets.
Compared to traditional manual approaches, the automated framework significantly reduced programming and quality control time, improved data accuracy, and provided reusable, flexible workflows that can easily accommodate new variables or data sources. The final deliverables, exportable in CSV, Excel, SQL, and XPT formats, are immediately submission-ready and integrable with other SDTM domains, demonstrating both practical efficiency and adherence to industry standards.
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