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SASInstitute A00-282 Exam Syllabus Topics:
| Section | Weight | Objectives |
|---|---|---|
| Clinical Trials Process | 5% | - Clinical trial lifecycle and protocol - Derive programming requirements from protocol and CRF |
| Regulatory Submissions | 5% | - Compliance for clinical data reporting - ICH and FDA guidelines |
| Manage Clinical Trials Data | 5% | - Access and explore clinical datasets - Use SQL and dictionary tables - Clean, merge, and subset data |
| 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 |
| Report Clinical Trials Results | 10% | - PROC REPORT and PROC PRINT - Produce tables, listings, and figures |
| Validate Clinical Trial Data Reporting | 20% | - Use PROC COMPARE and log review - Validation principles - Programming validation techniques |
| Clinical Trials Data Structures | 10% | - CDISC standards: SDTM, ADaM - Clinical domain structures - Define.xml and dataset specifications |
| Apply Statistical Procedures for Clinical Trials | 15% | - Basic statistical analysis for clinical data - PROC MEANS, FREQ, TABULATE |
SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:
An action plan that describes what will be done in a drug study, how it will be conducted, and why each part of the study is necessary is called:
- A. a clinical trial plan
- B. a data management plan
- C. a protocol
- D. a statistical analysis plan
Given the data set RAWBP that is sorted by SUBJECT TEST WEEK:
Baseline is defined as the week 0 value. Your colleague provides the following SAS program to calculate change from baseline:
data bp;
set rawbp;
by subject test week;
retain baseline;
if first.subject then baseline = value;
if week > 0 then change = value - baseline;
run;
What does the code calculate as the change from baseline for systolic blood pressure (SBP) at week 3?
- A. -40
- B. 30
- C. 40
- D. -30
Define.xml is an XML-based submission of a clinical study's:
- A. metadata
- B. protocol
- C. data
- D. results
Which option for PROC COMPARE will list all observations and variables found in only one of the two data sets being compared?
- A. LISTALL
- B. OUTALL
- C. OUTDIFF
- D. ALLOBS
In a Statistical Analysis Plan (SAP) the following statement is written:
To test the association between the pain intensity reported by the patient and the treatment the patient has been administered, a Cochran-Mantel-Haenszel test will be performed adjusting for the country of the patient's investigational site.
The following variables and levels are used:
- Pain intensity (PAIN): "No pain", "Mild pain", "Moderate pain", "Severe pain", "Most severe pain"
- Treatment group (TREAT): "Placebo", "Drug A", "Drug B"
- Country (COUNTRY): Eight different values.
The following program is written to perform this analysis:
proc freq data=pain;
by COUNTRY;
tables PAIN * TREAT / cmh;
run;
This code does not produce the analysis requested by the SAP.
What is wrong with this code?
- A. The variable COUNTRY should be on the TABLES statement instead of the BY statement.
- B. The option CMH should be on the PROC FREQ statement instead of on the TABLES statement.
- C. The variables PAIN and TREAT should be on the BY statement, and the variable COUNTRY should be on the TABLES statement.
- D. The variable PAIN should be on the BY statement along with the variable COUNTRY.
