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explore-eda / SilentNight-MT

A mock trial for In Home Assessment of Three Anti-Snoring Devices, a cross over study SRC-AI-SilentNight-10090 Version 3.0
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SilentNight-MT

A mock trial for the In Home Assessment of Three Anti-Snoring Devices, a cross over study based on the SRC-AI-SilentNight-10090 Protocol/SAP Version 3.0

The mock trial replicates the study visit schedule, portraying subject results as they complete the study. It involves creating Annotated Case Report Forms (aCRFs), standardizing data using the Study Data Tabulation Model (SDTM) with the CDISC Open Rules Engine, and generating tables, listings, and figures to reproduce the historical study results published on clinicaltrials.gov.

Repository Structure

/doc: Contains the protocol/SAP (prot_sap.pdf), CRFs for each study visit (casebook.pdf), specs to create SDTM dataset (define.xls), templates to create tables, listings and figures (shells.rtf)

/data: Includes the source data for the study

/dev /qc: Houses the code for standardizing data using SDTM, and producing study results.

/output: Stores the output files, including tables, listings, and figures.

Getting Started

To explore the mock trial, follow these steps:

  1. Clone the repository to your local machine.
  2. Navigate to the /code directory.
  3. Run the code scripts in the specified order to standardize data and reproduce study results.