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SAS Certified Professional: Clinical Trials Programming Using SAS 9.4

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Q_01 domain/d1 · medium multi discuss →

A newly hired clinical trials programmer is asked to identify the specific SAS data sets and derived variables that must be produced for a study. Which two source documents does the Content Guide identify as the basis for deriving these programming requirements?

A The Statistical Analysis Plan (SAP)
B The annotated Case Report Form (aCRF)
C The define.xml file
D The SDTM Implementation Guide
E The clinical study report

Explanation

The Clinical Trials Process objective states requirements are derived from both the SAP and the annotated CRF ^[1]. The define.xml and SDTM model belong to other objectives, not the derivation of programming requirements.

sources

✓ Verified source Sas ↗

Derive programming requirements from an SAP and an annotated Case Report Form.

Q_02 domain/d2 · medium multi discuss →

A programmer is documenting the two primary CDISC data models used in a clinical trial submission. According to the exam objectives, which two CDISC data models must a programmer be able to describe in terms of their structure and purpose?

A The SDTM data model
B The ADaM data model
C The define.xml data model
D The DICTIONARY table model
E The SAS V5 transport model

Explanation

The Clinical Trials Data Structures objective lists describing the structure and purpose of both the CDISC SDTM data model and the CDISC ADaM data model ^[1]. Define.xml and V5 requirements fall under Regulatory Submissions, not the data models themselves ^[1].

sources

✓ Verified source Sas ↗

Describe the structure and purpose of the CDISC SDTM data model. • Describe the structure and purpose of the CDISC ADaM data model.

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