• CRF Annotations:
Annotated a blank CRF by identifying the origin of data variables included in the submitted
datasets and cross-referenced the available fields in the CRF with their corresponding SDTM
variables.
• SDTM Data Development:
Created SDTM Demography dataset by writing independent code in SAS. Extracted variables
from Randomization, Disposition, Trial Arms, DM domains, and derived variables as per DM
requirements.
• Analysis Data Development:
Developed laboratory analysis dataset (ADLB) by using Lab data (LB) and ADSL (Subject Level
Analysis Dataset) for specified lab tests. Derived baseline values, change from the baseline,
and percent change variables and derived flags for various criteria.

• Analysis Data validation:
Validated an analysis-ready dataset Generated from VS.
Derived variables and flags for VSNCODE, VSBSL, VSDURN, BSLFLG, etc., compared the
created dataset with the dataset to be validated.
• Integrating data for Pk analysis:
Defining the technical integration of Pk concentration data and corresponding PK data in the
clinical database.
• Report Generation:
Generated a comprehensive report for the Summary of Demography and TEAE (TreatmentEmergent Adverse Events) using the MedDRA (Medical Dictionary for Regulatory Activities)
system organ class for a safety-evaluable population.
• Report validation:
Validated reports using MedDRA preferred terms for demographics, baseline characteristics,
and medical history. Calculated descriptive statistics and frequency distributions to
determine subject event reporting.