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Q25. Given the following output from the TTEST Procedure: Variable:
What is the t-test p-value?
A. 0.3121
B. <.0001
C. 37.49
D. 0.2041
Answer: B
Q26. Given the following data set:
Which type of clinical trials data is this?
A. Demographics
B. Laboratory
C. Medical History
D. Vital Signs
Answer: D
Q27. Identify the CDISC model with the following characteristics:
• XML-based content and format standard
• facilitates the archive and interchange of the metadata and data for clinical research
• provides an accurate audit trail that is 21 CRF Part II compliant
A. Analysis Data Model (ADaM)
B. Operational Data Model (ODM)
C. Study Data Tabulation Model (SDTM)
D. Trial Design Model (TDM)
Answer: B
Q28. Which function would be used to determine the number of elements in an existing array?
A. dim ()
B. n ()
C. sum ()
D. count ()
Answer: A
Q29. What is the main focus of 21 CFR Part 11?
A. electronic submission requirements
B. trial safety requirements
C. statistical calculation requirements
D. trial protocol requirements
Answer: A
Q30. Define.xml is an XML-based submission of a clinical study's:
A. results
B. metadata
C. data
D. protocol
Answer: B
Q31. Identify the data structure with the following characteristics:
• Contains one or more records per subject, per analysis parameter, and per analysis timepoint.
• May be derived from findings, events, interventions and special-purpose SDTM domains, or other ADaM datasets.
• A record can represent an observed, derived, or imputed value required for analysis.
A. General Data Structure (GDS)
B. Basic Data Structure (BDS)
C. Subject Level Analysis Data Set (ADSL)
D. Event Level Analysis Data Set (ADAE)
Answer: B
Q32. The following SAS program is submitted:
How many data sets are created and how many observations are in the data set(s)?
A. 1 data set named PVALUES with 1 observation.
B. 1 data set named PVALUES with 2 observations.
C. 2 data sets named PVALUES and PVALUES1 each with 1 observation.
D. 2 data sets named PVALUES1 and PVALUES2 each with 2 observations
Answer: C