CDISC Navigator supports the importing and exporting of CDISC data in either the SDTM (Study Data Tabulation Model) or the SEND (Standard for Exchange of Nonclinical Data) format.
CDISC SDTM is a unified way of transmitting information in drug studies with precise column names and a common file format. The CDISC STDM implementation in CDISC Navigator is compliant with the standards in the SDTM Implementation Guide 3.1.1.
CDISC SEND is an implementation of SDTM for nonclinical studies and specifies a consistent format for presenting and exchanging nonclinical data. The CDISC SEND implementation in CDISC Navigator is compliant with the standards in the SEND Implementation Guide 3.0.
For further information, please visit the Clinical Data Interchange Standards Consortium Web site at www.cdisc.org.
A typical workflow using CDISC Navigator tools begins by obtaining the SEND files from the labs, then using CDISC Preparer to generate the data and format needed for the NCA analysis. The NCA analysis will generate the necessary PK parameters and SEND columns, which in turn can be exported to a PP SEND file.
CDISC domains supported by CDISC Navigator include:
DM (Demographics): Essential standard variables that describe each subject in a clinical study.
SC (Subject Characteristics): Subject-related data not collected in other domains.
EX (Exposure): A subject’s exposure to protocol-specified study treatment.
PC (PK Concentration): Concentrations of drugs/metabolites in fluids or tissues as a function of time.
PP (PK Parameters): Pharmacokinetic parameters derived from pharmacokinetic concentration-time (PC) data.
CDISC datasets are saved as SAS Transport Format (XPORT) Version 5, 6, 8, or 9 files (.xpt). Datasets exported from CDISC Navigator are automatically saved as SAS transport files.
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