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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Validate Clinical Trial Data Reporting | 20% | - Use PROC COMPARE and log review - Validation principles - Programming validation techniques |
| 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 |
| Macro Programming for Clinical Trials | 15% | - Debugging macros - Create and call macros - Macro variables and parameters |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
| 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 |
| 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:
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;
Correct Answer: C 🗳️
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
Correct Answer: C 🗳️
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.
Correct Answer: A 🗳️
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;
Correct Answer: B 🗳️
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
Correct Answer: D 🗳️
