Free Clinical Trials Programming Using SAS 9.4 Practice Questions

Sample Practice Questions

Try these 10 sample questions from the Clinical Trials Programming Using SAS 9.4 practice bank. Each includes the answer and explanation. Continue with the interactive practice above to review the full question set.

1. 1Which phase includes the initial introduction of an investigational new drug into humans?

   1. A.Phase 2 clinical studies
   2. B.Phase 1 clinical studiesCorrect answer: B
   3. C.Phase 3 clinical studies
   4. D.Postmarketing clinical studies

   Explanation: "Phase 1 includes the initial introduction of an investigational new drug into humans." This is the defining phase for initial human introduction.

   Reference: Drug Development and Review Definitions — Phase I Clinical Studies

2. 2Which SDTM domain contains information about subject demographics in a clinical trial?

   1. A.AE
   2. B.CM
   3. C.DMCorrect answer: C
   4. D.LB

   Explanation: "These include Demographics (DM), Comments (CO), Subject Elements (SE), and Subject Visits (SV) [1], and are described in Section 5, Models for Special Purpose Domains." DM is the Demographics domain; the other codes designate different clinical data topics.

   Reference: Study Data Tabulation Model Implementation Guide — 2.4 Datasets Other Than General Observation Class Domains

3. 3What is the maximum SAS data set member name length enforced by the XPORT engine's Version 5 feature set?

   1. A.8 charactersCorrect answer: A
   2. B.16 characters
   3. C.32 characters
   4. D.40 characters

   Explanation: "The member name THIS_IS_LONG_NAMED_DATA exceeds the eight-character member name length, which is enforced by the Version 5 feature set in which the XPORT engine was introduced." The maximum is eight characters, not the longer limits of other SAS contexts.

   Reference: Error and Warning Messages for Transport Files — File library.member.DATA has too long a member name for the XPORT engine

4. 4In PROC SQL, which DICTIONARY table can be queried to identify tables containing a particular column?

   1. A.DICTIONARY.COLUMNSCorrect answer: A
   2. B.DICTIONARY.TABLES
   3. C.DICTIONARY.INDEXES
   4. D.DICTIONARY.MEMBERS

   Explanation: "select libname, memname, name from dictionary.columns where name='Country' and libname='SQL';" This example queries DICTIONARY.COLUMNS to find the Country column in tables.

   Reference: Accessing SAS System Information by Using DICTIONARY Tables — Using DICTIONARY.COLUMNS

5. 5For a nonmissing numeric score, the code is `if score >= 80 then category='HIGH'; else if score >= 50 then category='MID'; else category='LOW';`. What category is assigned when score is 85?

   1. A.LOW
   2. B.MID
   3. C.HIGHCorrect answer: C
   4. D.Missing

   Explanation: "Using IF-THEN statements with the ELSE statement causes SAS to execute IF-THEN statements until it encounters the first true statement." The first condition is true for 85, so HIGH is assigned and later branches are skipped.

   Reference: IF-THEN/ELSE Statement — Details

6. 6In an unweighted PROC FREQ one-way table, what does the frequency count for a level represent?

   1. A.The number of observations in the levelCorrect answer: A
   2. B.The percentage of all observations in the level
   3. C.The sum of all preceding level counts
   4. D.The count of nonmissing observations across all levels

   Explanation: "Frequency count, which is the number of observations in the level" The frequency is the observation count for that level.

   Reference: PROC FREQ Displayed Output — One-Way Frequency Tables

7. 7For `%macro list(data,var);`, what values do DATA and VAR receive from `%list(adsl,age)`?

   1. A.DATA=adsl and VAR=ageCorrect answer: A
   2. B.DATA=age and VAR=adsl
   3. C.DATA=adsl and VAR is null
   4. D.DATA is null and VAR=age

   Explanation: "the order in which you specify the values must match the order you list them in the %MACRO statement." Positional arguments are assigned in the order of the parameter list.

   Reference: %MACRO Statement — Positional parameters

8. 8Which PROC REPORT statement specifies the arrangement of report columns and spanning headings?

   1. A.DEFINE
   2. B.COLUMNCorrect answer: B
   3. C.BREAK
   4. D.COMPUTE

   Explanation: "Describe the arrangement of all columns and of headings that span more than one column COLUMN" COLUMN controls the arrangement and spanning headings.

   Reference: PROC REPORT Syntax — Syntax: task and statement table

9. 9According to ICH E6(R3), which approach to quality control of statistical programming used for trial reporting is appropriate?

   1. A.Implement quality control and document the checks performedCorrect answer: A
   2. B.Review only specifications and leave validation unrecorded
   3. C.Perform quality control but retain no record of the checks
   4. D.Retain source data while leaving programming checks undocumented

   Explanation: "The sponsor should ensure that appropriate and documented quality control of statistical programming and data analysis is implemented" The guidance calls for appropriate, documented quality control.

   Reference: E6(R3) Good Clinical Practice Guidance for Industry — Page 42, Statistical programming and data analysis, paragraph (b)

10. 10Which clinical trial phase includes early controlled studies to obtain preliminary effectiveness data in patients with the disease?

    1. A.Phase 1
    2. B.Phase 3
    3. C.Phase 2Correct answer: C
    4. D.Phase 4

    Explanation: "Phase 2 includes the early controlled clinical studies conducted to obtain some preliminary data on the effectiveness of the drug for a particular indication or indications in patients with the disease or condition." The question specifies the early controlled effectiveness studies described for Phase 2.

    Reference: Drug Development and Review Definitions — Phase 2 Clinical Studies