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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Clinical Trials Data Structures | 10% | - Clinical domain structures - CDISC standards: SDTM, ADaM - Define.xml and dataset specifications |
| Topic 2: Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Topic 3: Macro Programming for Clinical Trials | 15% | - Create and call macros - Macro variables and parameters - Debugging macros |
| Topic 4: Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Topic 5: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 6: Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Validation principles - Use PROC COMPARE and log review |
| Topic 7: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Aggregation and transposition - Derive variables and study days |
| Topic 8: Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Topic 9: Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Access and explore clinical datasets - Clean, merge, and subset data |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
1. This question will ask you to provide a line of missing code. Given the data set RAWBP that is sorted by SUBJECT TEST WEEK:
The following SAS program is submitted:
data bp;
set rawbp;
by subject test week;
retain baseline;
if first.test then baseline = .;
if week = 0 then baseline = value;
else if week > 0 then do;
<insert code here>
end;
run;
Which statement must be added to the program to calculate percent change from baseline?
A) pct_chg = ((value - baseline) /value)*100;
B) pct_chg = ((value - baseline) /baseline)*100;
C) pct_chg = ((baseline - value) /baseline)*100;
D) pct_chg = ((baseline - value) /value)*100;
2. What is the main focus of 21 CFR Part 11?
A) trial protocol requirements
B) trial safety requirements
C) statistical calculation requirements
D) electronic submission requirements
3. How does the code shown below help to validate report output?
data check;
set datlib.medhist;
mh_len = length(trim(mhcom1));
run;
proc freq data=check;
tables mh_len;
run;
A) It writes all values of the mhcom1 variable that are longer than 200 in the results.
B) It shows all the values for the length of mhcom1 in the results.
C) It helps the programmer determine which observation has the longest value for mhcom1.
D) It shows all the values for mhcom1 in the results.
4. This question will ask you to provide lines of missing code.
Given the following SCORE data set:
Variable LOCF contains the imputed score that would replace the missing SCORE value (based on last observation carried forward method).
Which SAS statements complete the program?
A) retain score; if first.subject then LOCF = .; if score ^= . then LOCF = score;
B) LOCF = lag(score); if first.subject then LOCF = .; if score ^= . then LOCF = score;
C) if first.subject then LOCF = .; if score = . then LOCF = lag(score);
D) retain LOCF; if first.subject then LOCF = .; if score ^= . then LOCF = score;
5. Given the following output from the TTEST Procedure: Variable:
What is the t-test p-value?
A) 0.2041
B) 0.3121
C) <.0001
D) 37.49
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: C |


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