Common Data for Human Clinical Studies

Text in draft

This section provides advice and examples for collecting and representing data in human clinical trials where the interest is evaluating tobacco product using the Clinical Data Acquisition Standards Harmonization (CDASH) model, the Study Data Tabulation Model (SDTM), including

• guidance on the use of domains and variables;

• sample annotated case report forms (aCRFs);

• examples of SDTM datasets, with text describing the situational context and pointing out records of note; and

The primary focus will be illustrating concept specifically related to clinical trials using tobacco products.  Advice and examples for topics that are essentially the same as for Human Clinical trials, can be found in ...