Q: A clinical trial protocol specifies that a subject's renal function should be categorized based on their estimated Glomerular Filtration Rate (eGFR). The categories are 'Normal' (eGFR >= 90), 'Mild' (60 <= eGFR < 90), 'Moderate' (30 <= eGFR < 60), and 'Severe' (eGFR < 30). Given the variable EGFR containing the numeric eGFR value, which code segments correctly derive the character variable EGFRCAT? (Select all that apply.)

if egfr >= 90 then egfrcat = 'Normal'; else if egfr >= 60 then egfrcat = 'Mild'; else if egfr >= 30 then egfrcat = 'Moderate'; else egfrcat = 'Severe';, if egfr = 90 then egfrcat = 'Normal';, if egfr egfr >= 30 then egfrcat = 'Moderate'; if 90 > egfr >= 60 then egfrcat = 'Mild'; if egfr >= 90 then egfrcat = 'Normal';, select; when (egfr >= 90) egfrcat = 'Normal'; when (egfr >= 60 and egfr = 30 and egfr < 60) egfrcat = 'Moderate'; when (egfr < 30) egfrcat = 'Severe'; otherwise; end;

Q: From the provided list, identify two SDTM domains classified under the Interventions general observation class. (Select Two)

VS (Vital Signs), LB (Laboratory Test Results), AE (Adverse Events), CM (Concomitant Medications), EX (Exposure)

Q: Consider the following macro, designed to generate a frequency count for a specified adverse event term within the ADAE dataset. %macro ae_freq(aeterm); title "Frequency of &aeterm"; proc freq data=adae; where aeptcd = &aeterm; tables aedecod; run; title; %mend ae_freq; %ae_freq(HEADACHE); The SAS log displays an error indicating a syntax issue near the `WHERE` statement. What is the cause of the error?

The `TITLE` statement cannot resolve macro variables., The macro parameter `aeterm` must be enclosed in quotes in the `WHERE` statement (for example, '&aeterm' or "&aeterm")., The `%mend` statement should not include the macro name., The macro parameter `aeterm` should be referenced with double quotes, as "&aeterm".

Q: To prevent the value of a grouping variable, such as AEBODSYS, from repeating on consecutive rows within a PROC REPORT output and instead have it span the relevant rows, which option should be specified in the REPORT statement?

COLLAPSE, SPANROWS, NOREPEAT, GROUPALL

Q: Although PROC COMPARE finds no differences between AE_FINAL and AE_QC, their PROC REPORT outputs differ visually in headers and formatting. What is the most accurate reason?

The AE_FINAL dataset has variable labels and formats defined, which are not present in the AE_QC dataset., The PROC COMPARE step mistakenly used the NOVALUES option, which suppressed the comparison of data values., The observations in AE_FINAL and AE_QC are sorted in a different order., A WHERE statement was active during the PROC COMPARE execution but not during the PROC REPORT steps.

Q: The SAS log for a macro execution displays the following note: `MLOGIC(FLAG_AE): %IF condition %upcase(&AESEV) = 'SEVERE' is TRUE`. What does this specific log entry indicate to the programmer debugging the macro?

A SAS statement containing the text 'SEVERE' was generated and sent to the compiler., The macro variable AESEV was successfully resolved and its value was 'SEVERE'., The macro named FLAG_AE has started its execution., The conditional logic within the FLAG_AE macro evaluated to a true result.

Q: To ensure traceability in a validation log for a clinical trial submission, a programmer needs to automatically record the name of the most recently created SAS dataset. Which automatic macro variable provides this information?

&SYSDSN, &SYSLAST, &SYSVER, &SYSPARM

Q: In the context of quality control, differentiating between program verification and validation is crucial. Which activity is an example of validation rather than verification?

The primary programmer checks their SAS log for errors, warnings, and unexpected notes., A lead programmer confirms that project-specific coding standards were followed., An independent programmer creates a new program based on the SAP to replicate a table., A peer programmer performs a line-by-line code review of the primary program.

Question 1

A study protocol mandates two key analyses: 1) comparing the mean reduction in tumor size (a quantitative outcome) across three different treatment arms (Drug A, Drug B, Placebo), and 2) tabulating the number of subjects in each treatment arm who achieved complete response (a categorical outcome). Which combination of procedures is best suited to perform these two analyses? (Select Two)

Accepted Answer

PROC CORR, PROC GLM, PROC FREQ, PROC TTEST, PROC MEANS

Question 2

When debugging a complex macro, which system option should be enabled to display the fully resolved SAS statements in the log as they are executed?

Accepted Answer

MSGLEVEL=I, SYMBOLGEN, MLOGIC, MPRINT

Question 3

A clinical trial protocol specifies that a subject's renal function should be categorized based on their estimated Glomerular Filtration Rate (eGFR). The categories are 'Normal' (eGFR >= 90), 'Mild' (60 <= eGFR < 90), 'Moderate' (30 <= eGFR < 60), and 'Severe' (eGFR < 30). Given the variable EGFR containing the numeric eGFR value, which code segments correctly derive the character variable EGFRCAT? (Select all that apply.)

Accepted Answer

if egfr >= 90 then egfrcat = 'Normal'; else if egfr >= 60 then egfrcat = 'Mild'; else if egfr >= 30 then egfrcat = 'Moderate'; else egfrcat = 'Severe';, if egfr < 30 then egfrcat = 'Severe'; else if egfr < 60 then egfrcat = 'Moderate'; else if egfr < 90 then egfrcat = 'Mild'; else if egfr >= 90 then egfrcat = 'Normal';, if egfr < 30 then egfrcat = 'Severe'; if 60 > egfr >= 30 then egfrcat = 'Moderate'; if 90 > egfr >= 60 then egfrcat = 'Mild'; if egfr >= 90 then egfrcat = 'Normal';, select; when (egfr >= 90) egfrcat = 'Normal'; when (egfr >= 60 and egfr < 90) egfrcat = 'Mild'; when (egfr >= 30 and egfr < 60) egfrcat = 'Moderate'; when (egfr < 30) egfrcat = 'Severe'; otherwise; end;

Question 4

From the provided list, identify two SDTM domains classified under the Interventions general observation class. (Select Two)

Accepted Answer

VS (Vital Signs), LB (Laboratory Test Results), AE (Adverse Events), CM (Concomitant Medications), EX (Exposure)

Question 5

Consider the following macro, designed to generate a frequency count for a specified adverse event term within the ADAE dataset.

%macro ae_freq(aeterm);
  title "Frequency of &aeterm";
  proc freq data=adae;
    where aeptcd = &aeterm;
    tables aedecod;
  run;
  title;
%mend ae_freq;

%ae_freq(HEADACHE);

The SAS log displays an error indicating a syntax issue near the `WHERE` statement. What is the cause of the error?

Accepted Answer

The `TITLE` statement cannot resolve macro variables., The macro parameter `aeterm` must be enclosed in quotes in the `WHERE` statement (for example, '&aeterm' or "&aeterm")., The `%mend` statement should not include the macro name., The macro parameter `aeterm` should be referenced with double quotes, as "&aeterm".

Question 6

To prevent the value of a grouping variable, such as AEBODSYS, from repeating on consecutive rows within a PROC REPORT output and instead have it span the relevant rows, which option should be specified in the REPORT statement?

Accepted Answer

COLLAPSE, SPANROWS, NOREPEAT, GROUPALL

Question 7

Although PROC COMPARE finds no differences between AE_FINAL and AE_QC, their PROC REPORT outputs differ visually in headers and formatting. What is the most accurate reason?

Accepted Answer

The AE_FINAL dataset has variable labels and formats defined, which are not present in the AE_QC dataset., The PROC COMPARE step mistakenly used the NOVALUES option, which suppressed the comparison of data values., The observations in AE_FINAL and AE_QC are sorted in a different order., A WHERE statement was active during the PROC COMPARE execution but not during the PROC REPORT steps.

Question 8

The SAS log for a macro execution displays the following note: `MLOGIC(FLAG_AE):  %IF condition %upcase(&AESEV) = 'SEVERE' is TRUE`. What does this specific log entry indicate to the programmer debugging the macro?

Accepted Answer

A SAS statement containing the text 'SEVERE' was generated and sent to the compiler., The macro variable AESEV was successfully resolved and its value was 'SEVERE'., The macro named FLAG_AE has started its execution., The conditional logic within the FLAG_AE macro evaluated to a true result.

Question 9

To ensure traceability in a validation log for a clinical trial submission, a programmer needs to automatically record the name of the most recently created SAS dataset. Which automatic macro variable provides this information?

Accepted Answer

&SYSDSN, &SYSLAST, &SYSVER, &SYSPARM

Question 10

In the context of quality control, differentiating between program verification and validation is crucial. Which activity is an example of validation rather than verification?

Accepted Answer

The primary programmer checks their SAS log for errors, warnings, and unexpected notes., A lead programmer confirms that project-specific coding standards were followed., An independent programmer creates a new program based on the SAP to replicate a table., A peer programmer performs a line-by-line code review of the primary program.

Question 11

Among the standard SDTM domains, which two are classified under the Special Purpose category? (Select Two)

Accepted Answer

DM (Demographics), VS (Vital Signs), EX (Exposure), AE (Adverse Events), CO (Comments)

Question 12

A review of the adverse event (AE) domain reveals the AESTDTC variable contains the following values. Which value is a valid representation of a date according to the ISO 8601 standard?

Accepted Answer

04-15-2023, 2023/04/15, 15APR2023, 2023-04-15

Question 13

Consider the following PROC SQL step designed to create a macro variable containing a list of unique study sites from the ADSL dataset. The SITEID variable is character with a length of 4.

sas
proc sql noprint;
  select unique siteid
  into :sitelist separated by ' '
  from adsl;
quit;

If the ADSL dataset contains the sites '101', '102', and '103', what will be the value of the macro variable &SITELIST?

Accepted Answer

'101' '102' '103', 101,102,103, 101 102 103, 101102103

Question 14

For deriving a Time-to-Event (TTE) variable, which logic most accurately finds the first lab value (LBVAL) exceeding its upper limit (LBNRHI) within 30 days after the first treatment date (TRT01SDT)?

Accepted Answer

For each subject, calculate the day number for each lab record as (LBDT - TRT01SDT) without adding 1. Then, create a flag for records where the day number is between 1 and 30 and LBVAL > LBNRHI. The TTE is the minimum day number for which the flag is positive., For each subject, sort the lab data by LBDT and iterate through all records (including dates before TRT01SDT). Identify the first record where LBVAL > LBNRHI; if this record's LBDT is within 30 days of TRT01SDT, calculate the TTE as (LBDT - TRT01SDT) + 1., For each subject, create a subset of lab records where LBDT is between TRT01SDT and TRT01SDT + 29 days, inclusive. Within this subset, filter for records where LBVAL > LBNRHI. If such a record exists, identify the record with the earliest LBDT and calculate TTE as (Earliest LBDT - TRT01SDT) + 1., For each subject, identify all records where LBVAL > LBNRHI (including pre-treatment dates). From these, select the record with the earliest LBDT. If (Earliest LBDT - TRT01SDT) + 1 is less than or equal to 30, set the TTE to this value; otherwise, the event is censored.

Question 15

When performing a validation check, what is the primary purpose of querying the `DICTIONARY.COLUMNS` table?

Accepted Answer

To list all assigned librefs and their corresponding physical paths., To verify the number of observations in each dataset within a library., To inspect variable-level attributes like type, length, format, and label., To retrieve dataset-level metadata such as labels and creation dates.

Question 16

Within a PROC REPORT step, which COMPUTE block correctly calculates the percentage of subjects with an adverse event using the EVENT_SUBJ and TOTAL_SUBJ variables?

Accepted Answer

compute PCT before;
  PCT = (EVENT_SUBJ / TOTAL_SUBJ) * 100;
endcomp;, compute PCT;
  PCT = EVENT_SUBJ / TOTAL_SUBJ * 100;
endcomp;, compute PCT;
  PCT = (EVENT_SUBJ.sum / TOTAL_SUBJ.sum) * 100;
endcomp;, compute PCT after TRT01A;
  PCT.sum = (EVENT_SUBJ.sum / TOTAL_SUBJ.sum) * 100;
endcomp;

Question 17

Consider the following SAS program intended to create a summary dataset named `VS_STATS` with the mean pulse rate (`AVAL`) for each treatment group (`TRT01P`):

sas
proc means data=advs;
  class TRT01P;
  var AVAL;
  out=VS_STATS(drop=_type_ _freq_) mean=PULSE_MEAN;
run;

Why will this code fail to execute as intended?

Accepted Answer

The `OUT=` option is not valid in PROC MEANS., The `DROP=` dataset option cannot be used on the output dataset., The statistic keyword and variable name must be specified in an `OUTPUT` statement., The `CLASS` statement cannot be used with the `OUT=` option.

Question 18

To ensure compliance with CDISC standards for the EXENDTC variable, a programmer needs to verify that all non-missing values adhere to the ISO 8601 extended date format (YYYY-MM-DD). Which SAS function is most suitable for validating the structure of these character strings?

Accepted Answer

The `PUT` function with the `E8601DA.` format to compare the output against the original string., The `INPUT` function with the `?? E8601DA.` informat modifier to test if the string can be read without errors., The `ANYDIGIT` function to check for the presence of numbers., The `COMPRESS` function to remove hyphens before checking the length.

Question 19

CDISC has developed a suite of standards to cover the entire research data lifecycle. From the list below, which two models are specifically designed to represent non-clinical study data and analysis-ready datasets, respectively? (Select Two)

Accepted Answer

CDASH, SEND, SDTM, ODM, ADaM

Question 20

To capture both the t-test statistics and the equality of variances test from PROC TTEST into SAS datasets, which ODS OUTPUT statement is correct?

Accepted Answer

ods output TTests=TTEST_STATS Equality=EQUALITY_STATS;, ods output out=ALL_STATS;, ods output Pooled=TTEST_STATS Satterthwaite=EQUALITY_STATS;, output TTests=TTEST_STATS Equality=EQUALITY_STATS;

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