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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Manage Clinical Trials Data | 5% | - Use SQL and dictionary tables - Access and explore clinical datasets - Clean, merge, and subset data |
| Topic 2: Apply Statistical Procedures for Clinical Trials | 15% | - PROC MEANS, FREQ, TABULATE - Basic statistical analysis for clinical data |
| Topic 3: Report Clinical Trials Results | 10% | - Produce tables, listings, and figures - PROC REPORT and PROC PRINT |
| Topic 4: Macro Programming for Clinical Trials | 15% | - Debugging macros - Create and call macros - Macro variables and parameters |
| Topic 5: Validate Clinical Trial Data Reporting | 20% | - Programming validation techniques - Validation principles - Use PROC COMPARE and log review |
| Topic 6: Regulatory Submissions | 5% | - ICH and FDA guidelines - Compliance for clinical data reporting |
| Topic 7: Clinical Trials Data Structures | 10% | - Clinical domain structures - CDISC standards: SDTM, ADaM - Define.xml and dataset specifications |
| Topic 8: Clinical Trials Process | 5% | - Derive programming requirements from protocol and CRF - Clinical trial lifecycle and protocol |
| Topic 9: Transform or Summarize Clinical Trials Data | 15% | - Derive variables and study days - Aggregation and transposition - Data step manipulation |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
What information can be found in the SAS Dictionary tables? There are two correct answer, Please select two correct answer.
- A. values contained within a specified format
- B. variables contained within a specified dataset
- C. datasets contained within a specified library
- D. values contained within a specified variable
Correct Answer: B,C 🗳️
The following SAS program is submitted:
%let Av=age;
%macro LABD(Av=weight);
%let Av=gend; %mend;
%LABD(Av=height)
%put Av is &Av;
What will be written to the SAS log?
- A. Av is gend
- B. Av is weight
- C. Av is age
- D. Av is height
Correct Answer: C 🗳️
You are working on validating the ADSL data set which contains the variables subject, sex, age, birth date, baseline height, and baseline weight. These variables are brought in from SDTM, and you derive new variables baseline BMI (from baseline height and weight) and age categorization (from age).
You get the following in the SAS log:
To reconcile this difference, which variable values will be most helpful to provide to the production programmer?
- A. AGECAT1 BLBMI
- B. BLBMI
- C. SUBJID BLHT BLWT BLBMI
- D. SUBJID BLBMI
Correct Answer: C 🗳️
Which statement will create a report footnote that identifies the date and time that the SAS program was executed?
- A. footnote1 = "Created on &sysdate9 &systime";
- B. footnote1 'Created on &sysdate9 &systime';
- C. footnote1 = 'Created on &sysdate9 &systime';
- D. footnote1 "Created on &sysdate9 &systime";
Correct Answer: D 🗳️
Identify the CDISC model with the following characteristics:
XML-based content and format standard facilitates the archive and interchange of the metadata and data for clinical research provides an accurate audit trail that is 21 CRF Part II compliant
- A. Analysis Data Model (ADaM)
- B. Study Data Tabulation Model (SDTM)
- C. Trial Design Model (TDM)
- D. Operational Data Model (ODM)
Correct Answer: D 🗳️
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