Last Updated: Aug 25, 2026
No. of Questions: 144 Questions & Answers with Testing Engine
Download Limit: Unlimited
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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Manage Clinical Trials Data | 5% | |
| Topic 2: Validate Clinical Trial Data Reporting | 20% | |
| Topic 3: Clinical Trials Data Structures | 10% | |
| Topic 4: Macro Programming for Clinical Trials | 15% | |
| Topic 5: Clinical Trials Process | 5% | |
| Topic 6: Report Clinical Trials Results | 10% | |
| Topic 7: Regulatory Submissions | 5% | |
| Topic 8: Transform or Summarize Clinical Trials Data | 15% | |
| Topic 9: Apply Statistical Procedures for Clinical Trials | 15% |
1. What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects
A) Good Clinical Practices
B) MedDRA
C) WHODrug
D) 21 CFR Part 11
2. Given an existing work data set (DM), the following code is submitted:
A) MRECALL
B) SYMBOLGEN
C) MPRINT
D) MLOGIC
3. Which date is presented using an ISO-8601 format?
A) 17JAN1980
B) 17/01/1980
C) 01/17/1980
D) 19800117
4. The VISIT data set is multiple records per subject, sorted by usubjid vistdtc vistm and contains the following variables:
The DEATH data set is one record per subject, sorted by usubjid vistdtc vistm and contains the following variables:
Which program will combine the DEATH and VISIT data sets by matching records?
A) data data_1;
merge death visit;
run;
B) data data_1;
set death visit;
by usubjid vistdtc vistm;
run;
C) data data_1;
merge death visit;
by usubjid vistm vistdtc;
run;
D) data data_1;
merge death visit;
by usubjid vistdtc vistm;
run;
5. 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 PAIN should be on the BY statement along with the variable COUNTRY.
B) The option CMH should be on the PROC FREQ statement instead of on the TABLES statement.
C) The variable COUNTRY should be on the TABLES statement instead of the BY statement.
D) The variables PAIN and TREAT should be on the BY statement, and the variable COUNTRY should be on the TABLES statement.
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: D | Question # 3 Answer: D | Question # 4 Answer: D | Question # 5 Answer: C |
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