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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Topic 2: Transform or Summarize Clinical Trials Data | 15% | - Data step manipulation - Aggregation and transposition - Derive variables and study days |
| Topic 3: Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Topic 4: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 5: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 6: Manage Clinical Trials Data | 5% | - Clean, merge, and subset data - Use SQL and dictionary tables - Access and explore clinical datasets |
| Topic 7: Macro Programming for Clinical Trials | 15% | - Debugging macros - Macro variables and parameters - Create and call macros |
| Topic 8: Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Use PROC COMPARE and log review - Validation principles |
| Topic 9: Clinical Trials Data Structures | 10% | - Clinical domain structures - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
1. Which two variables are required in BDS ADaM data sets?
(Choose two.)
A) PARAM
B) AVAL
C) STUDYID
D) ASEQ
2. This question will ask you to provide a line of missing code.
Given the following log entry:
Which line of code would produce the merge issue notes in the log?
A) if indm ne indisp then put 'MERGE ISSUE: ' _all_;
B) if indm ne indisp then put 'MERGE ISSUE: ' subjid= indm= indisp=;
C) %if indm ne indisp %then %put 'MERGE ISSUE: ' subjid= indm= indisp=;
D) if indm ne indisp then output 'MERGE ISSUE: ' subjid= indm= indisp=;
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
B) BINOMIAL ALPHA=0.1
C) BINOMIAL ALPHA=90
D) BINOMIAL ALPHA=0.9
4. Which code segment includes a statement that would reset the graphics counter and ensure a 6in by
4in image is produced?
A) ods graphics / width = 6in height = 4in reset;
B) ods graphics / reset width = 6in height = 4in;
C) ods graphics / width = 6in height = 4in counter = 1;
D) ods graphics / counter = 1 width = 6in height = 4in;
5. Which statement describes an aspect of all Phase II clinical trials?
A) designed to assess how well the drug works and further assess safety
B) designed to assess the pharmacovigilance, pharmacokinetics, and pharmacodynamics of a drug
C) in vitro and in vivo experiments using wide-ranging doses of the drug
D) randomized controlled multicenter trials on large patient groups
Solutions:
| Question # 1 Answer: A,C | Question # 2 Answer: B | Question # 3 Answer: B | Question # 4 Answer: B | Question # 5 Answer: A |
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