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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Macro Programming for Clinical Trials | 15% | |
| Topic 2: Manage Clinical Trials Data | 5% | |
| Topic 3: Clinical Trials Process | 5% | |
| Topic 4: Regulatory Submissions | 5% | |
| Topic 5: Report Clinical Trials Results | 10% | |
| Topic 6: Clinical Trials Data Structures | 10% | |
| Topic 7: Validate Clinical Trial Data Reporting | 20% | |
| Topic 8: Apply Statistical Procedures for Clinical Trials | 15% | |
| Topic 9: Transform or Summarize Clinical Trials Data | 15% |
1. You have been asked to import an Excel spreadsheet.
What will lead to substantial differences between the original Excel spreadsheet and the resulting SAS data set?
A) multiple value types within a single column
B) the number of rows to be read from the Excel file
C) multiple value types within a single row
D) the number of columns to be read from the Excel file
2. The following question will ask you to provide a line of missing code. The following program is submitted to output observations from data set ONE that have more than one record per patient.
Please enter the line of code that will correctly complete the program. Note: Case is ignored. Do not add leading or trailing spaces to your answer.
A) id;
PTON run;
B) BYSUBJID;
run;
C) BYSUBJID;
D) BYSUBJID;
BYSUBJID;
3. 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
4. Which program will report all created output objects in the log?
A) ods trace=log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
B) ods trace log; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
C) ods trace on; proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run;
D) proc ttest data=WORK.DATA1 ods=trace; class TREAT; var RESULTS; run;
5. 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 > 0) week = 1; when (day > 7) week = 2; otherwise week = 3; end;
B) select; when (day > 14) week = 3; when (day > 7) week = 2; otherwise week = 1; end;
C) if day > 0 then week = 1; else if day > 7 then week = 2; else if day > 14 then week = 3;
D) if day > 14 then week = 3; else if day > 7 then week = 2; else if day > 0 then week = 1;
Solutions:
| Question # 1 Answer: A | Question # 2 Answer: C | Question # 3 Answer: C | Question # 4 Answer: C | Question # 5 Answer: D |
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