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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
| Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Clean, merge, and subset data - Access and explore clinical datasets |
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Debugging macros - Macro variables and parameters |
| Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Use PROC COMPARE and log review - Validation principles |
| Transform or Summarize Clinical Trials Data | 15% | - Derive variables and study days - Aggregation and transposition - Data step manipulation |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
1. From the Statistical Analysis Plan, patients age is calculated as an integer relative to date randomized divided by 365.25.
Given the following annotated CRF:
Which programming code defines the patient's age?
A) age = int((today()-birthdt)/365.25);
B) age = int((birthdt-randdt)/365.25);
C) age= int(yrdif(birthdt,randdt, "act/365.25" ));
D) age = int((randdt-birthdt)/365.25);
2. The purpose of the ADaM model is to provide a framework that:
A) enables the creation of study patient profiles
B) enables the tabulation of the raw source data
C) can be used to generate the CDISC ODM
D) enables the statistical analysis of the data
3. What is the main focus of 21 CFR Part 11?
A) electronic submission requirements
B) trial safety requirements
C) trial protocol requirements
D) statistical calculation requirements
4. What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects
A) 21 CFR Part 11
B) WHODrug
C) Good Clinical Practices
D) MedDRA
5. The following text is displayed in your SAS log:
Which statement is necessary to store the p-values of the t-test in a data set called PVALUES in the WORK library?
A) ods TTests=WORK.PVALUES;
B) ods T-Tests=WORK.PVALUES;
C) ods output TTests=WORK.PVALUES;
D) ods output T-Tests=WORK.PVALUES;
Solutions:
| Question # 1 Answer: D | Question # 2 Answer: D | Question # 3 Answer: A | Question # 4 Answer: C | Question # 5 Answer: C |
