Common Workflows

Step-by-step guides for typical Trial Submission Studio use cases.

Workflow Overview

flowchart LR
    subgraph "1. Import"
        A[Load CSV]
    end

    subgraph "2. Configure"
        B[Select Domain]
        C[Map Columns]
    end

    subgraph "3. Quality"
        D[Handle CT]
        E[Validate]
    end

    subgraph "4. Output"
        F[Export XPT]
    end

    A --> B --> C --> D --> E --> F
    E -.->|Fix Issues| C
    style A fill: #e8f4f8, stroke: #333
    style F fill: #d4edda, stroke: #333

Workflow 1: Demographics (DM) Domain

Transform demographics source data to SDTM DM domain.

Source Data Example

SUBJECT_ID,AGE,SEX,RACE,ETHNIC,COUNTRY,SITE_ID
SUBJ001,45,Male,WHITE,NOT HISPANIC,USA,101
SUBJ002,38,Female,ASIAN,NOT HISPANIC,USA,102
SUBJ003,52,Male,BLACK,HISPANIC,USA,101

Steps

1. Import the CSV

   • File → Import CSV
   • Select your demographics file

2. Select DM Domain

   • Click on “Domain Selection”
   • Choose “DM - Demographics”

3. Map Columns

   Source	Target	Notes
   SUBJECT_ID	USUBJID	Subject identifier
   AGE	AGE	Age in years
   SEX	SEX	Maps to controlled terminology
   RACE	RACE	Controlled terminology
   ETHNIC	ETHNIC	Controlled terminology
   COUNTRY	COUNTRY	ISO 3166 codes
   SITE_ID	SITEID	Site identifier

4. Handle Controlled Terminology

   • “Male” → “M” (or keep if using extensible CT)
   • “Female” → “F”
   • Review RACE and ETHNIC values

5. Validate

   • Click Validate
   • Address any errors

6. Export

   • Export → XPT V5
   • Save as dm.xpt

Workflow 2: Adverse Events (AE) Domain

Transform adverse event data to SDTM AE domain.

Source Data Example

SUBJECT_ID,AE_TERM,START_DATE,END_DATE,SEVERITY,SERIOUS
SUBJ001,Headache,2024-01-15,2024-01-17,MILD,N
SUBJ001,Nausea,2024-02-01,,MODERATE,N
SUBJ002,Rash,2024-01-20,2024-01-25,SEVERE,Y

Steps

1. Import CSV

2. Select AE Domain

3. Map Columns

   Source	Target	Notes
   SUBJECT_ID	USUBJID
   AE_TERM	AETERM	Verbatim term
   START_DATE	AESTDTC	Start date
   END_DATE	AEENDTC	End date (can be blank)
   SEVERITY	AESEV	Controlled terminology
   SERIOUS	AESER	Y/N

4. Derive Required Variables

   • AESEQ (sequence number) - auto-generated
   • AEDECOD (dictionary term) - if available

5. Validate and Export

Workflow 3: Vital Signs (VS) Domain

Transform vital signs measurements to SDTM VS domain.

Source Data Example

SUBJECT_ID,VISIT,TEST,RESULT,UNIT,DATE
SUBJ001,BASELINE,SYSBP,120,mmHg,2024-01-10
SUBJ001,BASELINE,DIABP,80,mmHg,2024-01-10
SUBJ001,WEEK 4,SYSBP,118,mmHg,2024-02-07

Steps

1. Import CSV

2. Select VS Domain

3. Map Columns

   Source	Target	Notes
   SUBJECT_ID	USUBJID
   VISIT	VISIT	Visit name
   TEST	VSTESTCD	Test code
   RESULT	VSSTRESN	Numeric result
   UNIT	VSSTRESU	Result unit
   DATE	VSDTC	Collection date

4. Map Test Codes

   • SYSBP → Systolic Blood Pressure
   • DIABP → Diastolic Blood Pressure

5. Validate and Export

Workflow 4: Batch Processing

Process multiple domains from one source file.

Source Data

A comprehensive dataset with columns for multiple domains.

Steps

1. Import the source file
2. Process each domain
   • Filter relevant columns
   • Map to domain variables
   • Validate
3. Batch Export
   • File → Batch Export
   • Select all processed domains
   • Export to output folder

Workflow 5: Re-processing with Template

Use a saved mapping template for similar data.

Steps

1. First Time Setup

   • Import sample data
   • Create mappings
   • Save template: File → Save Mapping Template

2. Subsequent Processing

   • Import new data (same structure)
   • Load template: File → Load Mapping Template
   • Review and adjust if needed
   • Validate and export

Tips for All Workflows

Before You Start

• Review source data quality
• Identify required variables
• Prepare controlled terminology mappings

During Processing

• Validate after each major step
• Document any decisions
• Keep notes on exceptions

After Export

• Verify output files
• Run external validation
• Archive source and output files

Next Steps

• Troubleshooting - Common issues
• SDTM Domains - Domain reference