When implementing define.xml as part of a clinical trial study data submission package, which section is pivotal for explaining algorithmic derivations and handling of special data scenarios to a regulatory reviewer?
During a clinical trial, data were collected on a nominal categorical variable indicating patients' blood type (Type A, Type B, Type AB, Type O). The goal is to analyze the distribution of blood types among patients who experienced an adverse event versus those who did not. Which of the following statistical methods BEST suits the objective of comparing the distribution of a nominal categorical variable across two independent groups?
During the execution of a SAS program, the programmer wants not only to display each step generated by macro execution but also to show the values of macro variables at execution time. Which combination of system options should the programmer use?
In a clinical study comparing the time to event (such as time to relapse) between two different treatments, what SAS procedure would you use to estimate the survival function and compare the survival times between the two groups?
A pharmaceutical company is preparing submission materials for a new drug application. One of the key documents required by regulatory authorities is define.xml. Which of the following best describes the purpose of the define.xml file?