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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Use PROC COMPARE and log review - Validation principles |
| Macro Programming for Clinical Trials | 15% | - Create and call macros - Debugging macros - Macro variables and parameters |
| Clinical Trials Data Structures | 10% | - Clinical domain structures - Define.xml and dataset specifications - CDISC standards: SDTM, ADaM |
| Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Transform or Summarize Clinical Trials Data | 15% | - Aggregation and transposition - Data step manipulation - Derive variables and study days |
| Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Clean, merge, and subset data - Access and explore clinical datasets |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
Which is an acceptable variable label in a V5 transport file for regulatory submission?
- A. Character Result/Finding in Std Format
- B. Category for Reproductive System Findings
- C. Numeric Result/Finding in Standard Format
- D. Reason Medical History Not Done or Not Occurred
Correct Answer: A 🗳️
What is the primary purpose of programming validation?
- A. Ensure that the output from both the original program and the validation program match.
- B. Justify the means used to accomplish the outcome of a program and ensure its accurate representation of the original data.
- C. Document all specifications pertaining to programmed output and ensure all were reviewed during the programming process.
- D. Efficiently ensure any logic errors are discovered early in the programming process.
Correct Answer: B 🗳️
Given the following data set WORK.DM:
Which subjects will appear in the LOG file?
- A. 004 and 006
- B. 003 and 004
- C. 001 and 006
- D. 001 and 004
Correct Answer: A 🗳️
Given the following data set (AE):
Data will be reported by onset week. Day 1?
7 is Week 1, Day 8 ?14 is Week 2. Events beyond Day 14 are assigned Week 3 and will be reported as Follow-up events.
Which statements properly assign WEEK to each event?
- A. select; when (day > 14) week = 3; when (day > 7) week = 2; otherwise week = 1; end;
- B. select; when (day > 0) week = 1; when (day > 7) week = 2; otherwise week = 3; end;
- C. if day > 14 then week = 3; else if day > 7 then week = 2; else if day > 0 then week = 1;
- D. if day > 0 then week = 1; else if day > 7 then week = 2; else if day > 14 then week = 3;
Correct Answer: C 🗳️
Which statement assigns the system date and time to the character variable CURRDTTM?
- A. currdttm='%sysdate9 %systime';
- B. currdttm="&sysdate9 &systime";
- C. currdttm='&sysdate9 &systime';
- D. currdttm="%sysdate9 %systime";
Correct Answer: B 🗳️
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