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SASInstitute A00-282 Exam Syllabus Topics:

Section	Weight	Objectives
Topic 1: Regulatory Submissions	5%	- ICH and FDA guidelines - Compliance for clinical data reporting
Topic 2: Clinical Trials Data Structures	10%	- Clinical domain structures - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM
Topic 3: Macro Programming for Clinical Trials	15%	- Debugging macros - Create and call macros - Macro variables and parameters
Topic 4: Transform or Summarize Clinical Trials Data	15%	- Data step manipulation - Derive variables and study days - Aggregation and transposition
Topic 5: Clinical Trials Process	5%	- Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol
Topic 6: Manage Clinical Trials Data	5%	- Access and explore clinical datasets - Clean, merge, and subset data - Use SQL and dictionary tables
Topic 7: Validate Clinical Trial Data Reporting	20%	- Validation principles - Programming validation techniques - Use PROC COMPARE and log review
Topic 8: Apply Statistical Procedures for Clinical Trials	15%	- PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data
Topic 9: Report Clinical Trials Results	10%	- PROC REPORT and PROC PRINT - Produce tables, listings, and figures

SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

Question 1

A Treatment-Emergent Adverse Event (TEAE) is commonly defined as any event that occurs on or after the date and time of:

A. baseline assessment
B. study enrollment
C. first dose of study drug
D. informed consent

Question 2

Study day is defined as DCMDATE minus RFSTDTC +1

Which statement will compute the study day correctly without producing notes for missing values in the log?

A. If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,date9.)- input(RFSTDTC,yymmdd8.)+1;
B. STUDYDAY=DCMDATE-RFSTDTC+1;
C. If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,yymmdd8.)- input(RFSTDTC,date9.)+1;
D. STUDYDAY=input(DCMDATE,yymmdd8.)-input(RFSTDTC,date9.)+1;

Question 3

You want 90% confidence limits for a binomial proportion from a one-way table with PROC FREQ.
Which option must you add to the TABLES statement?

A. BINOMIAL ALPHA=0.9
B. BINOMIAL
C. BINOMIAL ALPHA=0.1
D. BINOMIAL ALPHA=90

Question 4

Which statement outputs all possible missing values of LBORRES?

A. if missing(LBORRES) then output;
B. if LBORRES <= .A then output;
C. if LBORRES = . then output;
D. if LBORRES in (. ._) then output;

Question 5

This item will ask you to determine the missing code.
In the data shown below, each record represents a single treatment period and contains a character SUBJID and non-missing numeric dates EXSTDT and EXENDT.
The Duration of Treatment (in days) for a single period is defined as Treatment End Date - Treatment Start Date + 1. For each subject, the Total Duration (in days) is defined as the sum of durations of treatment across all treatment periods.

Which code segment generates the new data set, EX2, which contains a single record per subject and includes the Duration of Treatment?
data EX2
set EX;
by subjid exstdt exendt;
<insert code here>
run;

A. retain TotalDur;
duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.subjid then Totaldur = duration;
if last.subjid;
B. retain TotalDur;
duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.exstdt then TotalDur = duration;
if last.exstdt;
C. duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.subjid then TotalDur = duration;
if last.subjid;
D. duration = exendt - exstdt + 1;
TotalDur = TotalDur + duration;
if first.exstdt then TotalDur = duration;
if last.exstdt;