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01. While preparing to compare the independently reprogrammed ADQS dataset for Study CARD-311 (a cardiology outcomes trial), the QC programmer notices the following line in the SAS log for their own program:
WARNING: Variable TRTEMFL not found in data set WORK.ADQS_QC. TRTEMFL will be considered as missing for all subsequent statements.
What should the QC programmer do before running PROC COMPARE against the production dataset?
a) Investigate why TRTEMFL was not created in the QC program — for example, a misspelled source variable or a step that did not execute — and correct it before comparing the datasets.
b) Proceed directly to PROC COMPARE, since a WARNING (unlike an ERROR) does not prevent the program from producing output.
c) Ignore the WARNING, since PROC COMPARE is understood to substitute a default value, such as a blank or zero, for any variable that is missing from one of the two datasets before running its value-by-value comparison.
d) Add TRTEMFL to the DROP statement so PROC COMPARE does not attempt to compare it.
02. A programmer on Study ONCB-301 is asked to explain the purpose of the ADSL dataset within the ADaM data structure.
Which description is correct?
a) ADSL contains one record per adverse event, matching the structure of the SDTM AE domain
b) ADSL contains one record per subject, holding derived subject-level variables such as treatment group and analysis-population flags that other ADaM datasets can merge onto
c) ADSL is used only for producing subject-level Listings, such as a screening-failure Listing, and plays no role in the derived variables that feed Tables or Figures built from datasets like ADAE or ADLB
d) ADSL is a duplicate of the SDTM DM domain with no additional derived content
03. In a cardiology safety study, a programmer defines a macro with positional parameters:
%macro aetable(pop,soc); ... %mend aetable;
It is invoked as %aetable(safety,Cardiac disorders);. Which statement correctly describes how the parameters are assigned inside the macro?
a) Only POP receives a value; SOC remains blank because a macro can resolve at most one positional parameter per call.
b) SOC resolves to SAFETY because positional parameters are matched alphabetically by parameter name, not by call order, the same alphabetical ordering PROC SORT would apply to a BY statement's variable list.
c) POP resolves to SAFETY and SOC resolves to "Cardiac disorders" because positional parameters are matched strictly by their left-to-right order in the invocation.
d) The macro fails to compile because positional parameters require an equal sign (POP=SAFETY) in the invocation.
04. A cardiology safety study requires a Figure displaying the Kaplan-Meier survival curve for time to first major adverse cardiac event (MACE), by treatment group. Which approach correctly produces this deliverable?
a) PROC LIFETEST with the PLOTS=SURVIVAL option (or ODS GRAPHICS enabled), which computes the Kaplan-Meier estimates and produces the survival curve Figure.
b) PROC REPORT with a LINE statement grouped by treatment, since PROC REPORT can render any clinical Figure directly from summary statistics.
c) PROC FREQ with a CROSSTAB table request, since survival curves are a specialized form of contingency table.
d) PROC MEANS with a BY treatment group statement, requesting the mean time to event for each group, the same plain arithmetic-mean summary PROC MEANS would compute for an ordinary continuous lab value with no censoring involved.
05. The SDTM VS domain for Study DBTM-112 stores VSDTC, the collected date each vital-signs measurement was taken at a site visit.
An ADaM analysis dataset instead reports AVISIT and AVISITN, assigning each measurement to a defined analysis-visit window.
What best explains the relationship between these two representations?
a) AVISIT is collected directly from the site alongside VSDTC, rather than being derived afterward
b) VSDTC is used only in ADaM datasets and does not appear in the SDTM VS domain
c) VSDTC and AVISIT store the exact same information, so either can be substituted for the other in analysis, since a raw collected visit date and a standardized analysis-visit window are treated as interchangeable inputs to a PROC MEANS BY-visit summary.
d) AVISIT/AVISITN are derived by mapping the collected visit date into a standardized analysis-visit window, enabling consistent comparison across subjects whose actual visit dates vary
06. During a cardiology safety study (Study CVRK-204), a SAS programmer preparing SDTM and ADaM datasets for a regulatory submission package asks a lead programmer what their responsibility is regarding "regulatory submission" work.
Which description correctly reflects the scope of the programmer's task?
a) Assess whether the sponsor's overall regulatory strategy for the submission meets the reviewing agency's expectations
b) Determine whether the trial's cardiovascular safety data is strong enough to support the sponsor's marketing approval application
c) Ensure the submitted datasets and TLF outputs conform to the naming, structure, and format conventions expected for the submission package
d) Decide which specific adverse events observed in the study must be disclosed to the regulatory agency
07. A pediatric trial's macro library includes:
data _null_; n = 42; call symput('nA', n); call symputx('nB', n); run; %put |&nA.| |&nB.|;
Which statement correctly describes the difference between the two resulting log entries?
a) Both &nA. and &nB. resolve identically to "42", because CALL SYMPUT and CALL SYMPUTX perform the same automatic trimming.
b) &nA. resolves with leading blanks from the numeric-to-character conversion, while &nB. is automatically trimmed by CALL SYMPUTX, so the two log entries display differently.
c) CALL SYMPUT fails on a numeric argument, so only &nB. resolves to a value.
d) &nB. resolves with leading blanks while &nA. is trimmed, because CALL SYMPUTX preserves the BEST12. format and CALL SYMPUT trims it, reversing the actual roles the two routines play in a numeric-to-character conversion.
08. For Study CVRK-204, the SDTM AE domain records AESTDTC (the collected onset date of each adverse event) exactly as reported.
Which statement correctly distinguishes this from the TRTEMFL variable found in the corresponding ADAE dataset?
a) TRTEMFL is a derived flag computed by comparing the event's timing to treatment start/end dates, classifying whether the event was treatment-emergent — a determination not present in the raw SDTM record
b) TRTEMFL is entered directly by site staff at the time the adverse event is reported
c) AESTDTC already indicates whether the event was treatment-emergent, making TRTEMFL redundant, because a single as-collected onset date is treated as sufficient on its own to classify emergence without ever being compared against the subject's TRTSDT or TRTEDT treatment dates.
d) TRTEMFL and AESTDTC represent the identical collected value, simply renamed for use in the ADaM dataset
09. On an allergy immunotherapy trial (ALG-183), a programmer must analyze time from first dose to first occurrence of a systemic allergic reaction. Roughly 30% of subjects had not experienced the event by the end of the observation period and are censored at their last contact date.
Which procedure correctly accounts for this censoring while analyzing time-to-event?
a) PROC MEANS, computing the average observed follow-up time for all subjects the same way it would summarize a simple continuous lab value, without distinguishing subjects who had the systemic reaction from the 30% who were censored at last contact.
b) PROC TTEST, treating "time to event" as an ordinary continuous variable and comparing its mean between groups.
c) PROC FREQ, tabulating the proportion of subjects who experienced the event by the study's end, ignoring the actual time to event.
d) PROC LIFETEST, using the time variable together with a censoring indicator to properly account for subjects who had not yet experienced the event.
10. An auditor reviewing Study CNSR-018's submission package asks a programmer to demonstrate that a specific value used in an efficacy summary table can be traced back to the data originally collected at the site.
Which characteristic of the CDISC data structures makes this traceability possible?
a) Traceability is achieved by regenerating the original source data from the summary table after the fact, using a PROC COMPARE-style reverse-engineering pass to reconstruct the case report form values from the analyzed TLF output.
b) SDTM organizes collected data into a standardized, source-traceable tabulation that downstream ADaM derivations and analyses can be linked back to
c) ADaM datasets are themselves the original source of all trial data, so tracing stops at the ADaM layer
d) TLF outputs contain the only record of how a value was originally collected
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