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.
Test results, examinations, and observations for subjects in a nonclinical study are represented in a series of SEND domains.
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. 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.
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
- Trial Summary (TS)
- Trial Sest (TX)
- Demographics (DM)
- Body Weight (BW)
- Laboratory Test Results (LB)
- Organ Measurements (OM)
- Microscopic Findings (MI)
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.
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
- MI documentation still in progress