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Accelerated Version Practice Exam
Question 1. What is the primary objective of a Phase I clinical trial? A) To compare the new drug with standard therapy in a large population B) To evaluate the drug’s efficacy in the target disease C) To assess safety, tolerability, and pharmacokinetics in healthy volunteers D) To monitor long‑term adverse events after marketing Answer: C Explanation: Phase I studies are first‑in‑human trials focused on safety, tolerability, dose‑finding, and pharmacokinetic profiling, typically in healthy subjects.
Question 2. Which role is primarily responsible for defining the statistical hypotheses and analysis sets in a clinical study? A) Data Manager B) Biostatistician C) Clinical Research Associate D) SAS Programmer Answer: B
Accelerated Version Practice Exam
Explanation: The biostatistician creates the Statistical Analysis Plan (SAP), specifying hypotheses, analysis populations, and methods.
Question 3. According to 21 CFR Part 11, which of the following is NOT a required element for electronic signatures? A) Unique user identification B) Signature appearance identical to a handwritten signature C) Ability to link the signature to the record being signed D) Use of secure, password‑protected login Answer: B Explanation: Part 11 does not require the electronic signature to visually resemble a handwritten one; it must be uniquely linked to the signer and record.
Question 4. In the CDISC SDTM model, which domain typically contains subject‑level demographic information? A) AE B) DM
Accelerated Version Practice Exam
Question 6. What SAS procedure is most appropriate for retrieving metadata about a library’s data sets? A) PROC CONTENTS B) PROC PRINT C) PROC FREQ D) PROC SQL Answer: D Explanation: PROC SQL can query SASHELP.VTABLE or DICTIONARY.TABLES to obtain detailed metadata about libraries and data sets.
Question 7. When exploring a clinical data set, which PROC option would you use to display variable labels in the output of PROC PRINT? A) LABEL B) FORMAT C) VARLABELS D) NOOBS
Accelerated Version Practice Exam
Answer: A Explanation: The LABEL option tells PROC PRINT to show variable labels instead of names.
Question 8. Which SAS function converts a character date in the form ‘YYYY‑MM‑DD’ to a SAS date value? A) INPUT(date,$10.) B) MDY() C) INPUT(date,$10.,yymmdd10.) D) DATEPART() Answer: C Explanation: INPUT with the YYMMDD10. informat parses a character string ‘YYYY‑MM‑DD’ into a SAS date numeric value.
Question 9. What is the purpose of the RETAIN statement in a DATA step? A) To drop variables from the output data set
Accelerated Version Practice Exam
Question 11. In the context of handling missing data, BOCF stands for: A) Baseline Observation Carried Forward B) Best Outcome Censored First C) Binary Outcome Cumulative Frequency D) Baseline Only Censoring Factor Answer: A Explanation: BOCF replaces a missing post‑baseline value with the baseline measurement.
Question 12. Which PROC produces a transposed data set where each subject’s repeated measurements become separate variables? A) PROC SORT B) PROC TRANSPOSE C) PROC REPORT D) PROC UNIVARIATE
Accelerated Version Practice Exam
Answer: B Explanation: PROC TRANSPOSE pivots rows to columns (or vice‑versa), creating one observation per subject with measurement‑specific variables.
Question 13. Which ODS destination is most commonly used to create a PDF version of a clinical table? A) ODS HTML B) ODS RTF C) ODS PDF D) ODS LISTING Answer: C Explanation: ODS PDF writes output to a Portable Document Format file, suitable for final clinical reporting.
Question 14. When generating a summary table of adverse events, which SAS procedure provides the count of unique subjects experiencing each event? A) PROC FREQ with the NLEVELS option
Accelerated Version Practice Exam
Question 16. What does the MPRINT system option do when debugging a macro? A) Shows macro variable resolution in the log B) Prints the generated SAS code to the log C) Displays the macro call stack D) Suppresses all macro‑related messages Answer: B Explanation: MPRINT writes the SAS statements generated by macro execution to the log, helping debug macro logic.
Question 17. Which of the following statements about PROC REPORT is FALSE? A) DEFINE statements can set column widths and formats B) BREAK statements add summary rows after groups C) COMPUTE blocks can be used to create new variables on the fly D) PROC REPORT cannot output to ODS destinations
Accelerated Version Practice Exam
Answer: D Explanation: PROC REPORT can write to any ODS destination (PDF, RTF, HTML, etc.). The statement is false.
Question 18. In a clinical trial, the “intent‑to‑treat” (ITT) population is defined as: A) All subjects who completed the study per protocol B) All randomized subjects regardless of adherence C) Only subjects who received at least one dose of study drug D) Subjects who have evaluable efficacy data Answer: B Explanation: ITT includes every subject randomized, preserving the randomization balance, irrespective of protocol deviations.
Question 19. Which PROC option is required to produce a p‑value for a chi‑square test of independence in PROC FREQ? A) MEASURES
Accelerated Version Practice Exam
Question 21. Which of the following is the correct way to capture the output data set from PROC MEANS? A) ODS OUTPUT Summary=means_out; B) PROC MEANS DATA=raw OUT=means_out; C) PROC MEANS DATA=raw; OUTPUT OUT=means_out; D) PROC MEANS DATA=raw; ODS SELECT Summary; Answer: C Explanation: The OUTPUT statement inside PROC MEANS creates an output data set (means_out) containing the statistics.
Question 22. What does the SAS system option MSGLEVEL=I control? A) The level of informational messages displayed in the log B) The inclusion of macro debugging information C) The handling of invalid data values D) The automatic generation of index files
Accelerated Version Practice Exam
Answer: A Explanation: MSGLEVEL=I sets the log to display informational messages, useful for validation checks.
Question 23. Which CDISC term describes a variable that identifies the visit number within a study? A) VISITNUM B) VISITSEQ C) VISITID D) VISITORD Answer: A Explanation: VISITNUM is the standard SDTM variable representing the chronological order of a study visit.
Question 24. In the context of regulatory submissions, the define.xml file is primarily used to: A) Provide a human‑readable summary of the statistical analysis plan
Accelerated Version Practice Exam
Question 26. When creating a macro that accepts a list of variables, which macro quoting function prevents unintended macro resolution? A) %NRSTR() B) %UPCASE() C) %SYSFUNC() D) %EVAL() Answer: A Explanation: %NRSTR masks special characters (commas, parentheses) in macro arguments, preserving the list intact.
Question 27. Which PROC is best suited to compare two ADaM datasets for equality of observations and variable attributes? A) PROC COMPARE B) PROC SORT C) PROC FREQ D) PROC TRANSPOSE
Accelerated Version Practice Exam
Answer: A Explanation: PROC COMPARE checks data set contents, variable types, lengths, and can report differences.
Question 28. What is the default behavior of PROC PRINT when the data set contains a variable with a format of DATE9.? A) The variable is printed as a numeric SAS date value B) The variable is printed using the DATE9. character representation C) The variable is omitted from the output D) PROC PRINT automatically converts it to a datetime value Answer: B Explanation: PROC PRINT respects variable formats; DATE9. displays dates as ‘ddMONyyyy’.
Question 29. Which of the following is NOT a standard SDTM domain for recording concomitant medications?
Accelerated Version Practice Exam
Question 31. Which SAS option disables the automatic creation of index files for SAS data sets? A) NOINDEX B) NODATE C) NOXWAIT D) NOFMTERR Answer: A Explanation: The NOINDEX option prevents SAS from building an index when a data set is created.
Question 32. When using PROC UNIVARIATE, which statement provides a Shapiro‑Wilk test for normality? A) NORMAL B) WILKS C) PLOTS(NONE)
Accelerated Version Practice Exam
D) TESTNORMAL
Answer: A Explanation: The NORMAL option requests several normality tests, including Shapiro‑Wilk.
Question 33. Which of the following is a valid reason to use PROC SORT with the NODUPKEY option? A) To remove duplicate observations based on the BY variables B) To sort the data set in descending order C) To create a temporary index for faster access D) To merge two data sets without a BY statement Answer: A Explanation: NODUPKEY removes duplicate rows that have identical values for the BY variables.
