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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Transform or Summarize Clinical Trials Data | 15% | - Derive variables and study days - Data step manipulation - Aggregation and transposition |
| Validate Clinical Trial Data Reporting | 20% | - Use PROC COMPARE and log review - Validation principles - Programming validation techniques |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Macro Programming for Clinical Trials | 15% | - Debugging macros - Create and call macros - Macro variables and parameters |
| Clinical Trials Data Structures | 10% | - Clinical domain structures - CDISC standards: SDTM, ADaM - 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% | - Clean, merge, and subset data - Access and explore clinical datasets - Use SQL and dictionary tables |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
1. A Statistical Analysis Plan defines study day as the number of days between the visit date and the date of randomization plus one day.
The following SAS program is submitted using a macro from the project's library:
How is the STUDYDAY macro defined?
A) %MACRO studyday(visit=, rand=);
&visit. ?&rand. + 1
%MEND studyday;
B) %MACRO studyday(rand, visit);
&vdt. ?&rdt. + 1
%MEND studyday;
C) %MACRO studyday(rand, visit);
&visit. ?&rand. + 1
%MEND studyday;
D) %MACRO studyday(rand=, visit=);
&vdt. ?&rdt. + 1
%MEND studyday;
2. What is the main focus of Good Clinical Practices (GCP)?
A) standard monitoring practices
B) harmonized data collection
C) protection of subjects
D) standard analysis practices
3. The following SAS program is submitted:
proc sort data=SASUSER.VISIT out=PSORT; by code descending date cost; run; Which statement is true regarding the submitted program?
A) The variable CODE is sorted by ascending order.
B) The PSORT data set is stored in the SASUSER library.
C) The descending option applies to the variable CODE.
D) The descending option applies to the DATE and COST variables.
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. What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects
A) MedDRA
B) WHODrug
C) 21 CFR Part 11
D) Good Clinical Practices
Solutions:
| Question # 1 Answer: C | Question # 2 Answer: C | Question # 3 Answer: A | Question # 4 Answer: B | Question # 5 Answer: D |
