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  1. Management of Clinical Trial Data:

In clinical trials, data collection, validation, and management are all important.

Compliance with regulatory regulations (for example, FDA and EMA).

  • CDISC Guidelines:

CDISC (Clinical Data Interchange Standards Consortium) standards, such as SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model), must be understood and implemented.

  • Import and export of data:

Importing and exporting clinical trial data into SAS datasets from multiple sources such as Excel, databases, and other formats.

  • Transformation of data:

Data transformation and modification are used to prepare datasets for statistical analysis.

SAS programming is used for data cleansing and standardisation.

  • Quality assurance and validation:

Validation tests and data cleaning techniques are used to ensure data quality.

Detecting and resolving data errors and conflicts.

  • Statistical Evaluation:

Performing statistical studies such as descriptive statistics, inferential statistics, and modelling (for example, regression and survival analysis).

Creating clinical study tables, lists, and figures (TLFs).

  • Analysis of Safety and Efficacy:

Analysing safety (adverse events) and effectiveness (primary and secondary outcomes) data.

Results interpretation and reporting to assist regulatory filings.

  • ADaM Datasets and SDTM Mapping:

For standardised reporting, raw data is mapped to SDTM domains.

Creating and producing ADaM datasets for analysis.

  • Statistical Modelling:

SAS programming is used to create analytical datasets, summarise statistics, and generate reports.

For efficiency, specialised macros and reusable code are created.

  1. Compliance with regulations:

Ensuring adherence to regulatory rules and standards (for example, ICH-GCP, 21 CFR Part 11).

Data preparation and submission for regulatory assessments and clearances.

  1. Reporting Clinical Trials:

Clinical study reports (CSRs) and other regulatory documentation are created.

Making tables, figures, and lists (TFLs) for regulatory filings.