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--- | ||
title: "Introduction" | ||
output: html_document | ||
date: Sep-13-2024 | ||
--- | ||
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# Introduction | ||
The Standard for Exchange of Nonclinical Data (__SEND__), developed by the Clinical | ||
Data Interchange Standards Consortium (CDISC), offers a __structured__ __electronic__ | ||
__format__ to organize and exchange __nonclinical__ study data among sponsor companies, | ||
contract research organizations (CROs), and health authorities. | ||
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Test results, examinations, and observations for subjects in a nonclinical study | ||
are represented in a series of SEND domains. | ||
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A __domain__ is defined as a collection of logically related observations with a | ||
common topic. Typically, each domain is represented by a single dataset. | ||
- [Domain vs | ||
dataset](https://www.cdisc.org/kb/articles/domain-vs-dataset-whats-difference). | ||
All datasets are structured as flat files with rows representing observations | ||
and columns representing variables. | ||
You can think a domain is just a dataset or table with columns and rows. | ||
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There are domains like Trial Summary (TS) and Trial Sets (TX) which provide | ||
information about trial design. Demographics (DM) provide information about | ||
each animal. On the other hand, domain like Laboratory Test Results (LB) contain | ||
information about laboratory test of different end points. | ||
SENDsanitizer generate synthetic dataset for | ||
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- Trial Summary (TS) | ||
- Trial Sest (TX) | ||
- Demographics (DM) | ||
- Body Weight (BW) | ||
- Laboratory Test Results (LB) | ||
- Organ Measurements (OM) | ||
- Microscopic Findings (MI) | ||
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Each of these domain in real data have STUDYID column. | ||
Value of which (STUDYID) is repalced by a randomly generated number in synthetic data. | ||
Also, All the Dates were replaced by XXXX-XX-XX. | ||
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SENDsanitizer either removes or replaces (with predefined text) potentially | ||
identifiable information from TS, TX, and DM domain. | ||
For numberical results (in BW, LB, OM domain), SENDsanitizer generate synthetic | ||
data using Bayesian regression model. | ||
For details see [Bayesian Regression Model Article](../articles/bayesian_regression_model.html) | ||
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- MI documentation still in progress |
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