CDISC Data Preparer

The CDISC Data Preparer object produces analysis ready datasets (SAMPLE and DOSE) in Phoenix, using CDISC formatted dataset inputs of either SDTM (Study Data Tabulation Model) or SEND (Standard for Exchange of Nonclinical Data).

•CDISC SDTM is a unified way of transmitting information in drug studies with precise column names and a common file format. CDISC Data Preparer produces output in the STDM format that 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 Data Preparer produces output in the SEND format that 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.

CDISC input datasets must have the following domains in order for the CDISC Data Preparer object to generate a PK dataset:

DM: Demographic information; one row per subject
PC: PK concentrations data, one record per concentration per analyte
EX: Exposure, one record per constant dosing interval per subject

The input dataset can also include Finding domains such as:

EG: ECG tests
LB: Laboratory tests
PE: Physical examinations
QS: Questionnaire
SC: Subject characteristics
VS: Vital signs
MB: Microbiology specimens
PP: Pharmacokinetics parameters

Findings domains can contain time-dependent data, but the times do not necessarily match the times of the samples or treatments. The CDISC Data Preparer object uses processing rules to locate data corresponding to the time of data collection.

Use one of the following to add the object to a Workflow:

Right-click menu for a Workflow object: New > Data Management > CDISC Data Preparer.
Main menu: Insert > Data Management > CDISC Data Preparer.
Right-click menu for a worksheet: Send To > Data Management > CDISC Data Preparer.

Note:To view the object in its own window, select it in the Object Browser and double-click it or press ENTER. All instructions for setting up and execution are the same whether the object is viewed in its own window or in Phoenix view.

Additional information is available for the following topics:

User interface description
Results

See also “CDISC Data Preparer Example”.