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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Clinical Trials Data Structures | 10% | |
| Topic 2: Macro Programming for Clinical Trials | 15% | |
| Topic 3: Report Clinical Trials Results | 10% | |
| Topic 4: Transform or Summarize Clinical Trials Data | 15% | |
| Topic 5: Regulatory Submissions | 5% | |
| Topic 6: Clinical Trials Process | 5% | |
| Topic 7: Manage Clinical Trials Data | 5% | |
| Topic 8: Validate Clinical Trial Data Reporting | 20% | |
| Topic 9: Apply Statistical Procedures for Clinical Trials | 15% |
1. Which CDISC filename contains these items?
- Variable attributes
- Controlled terminology
- Computational methods
A) SDTMIG.pdf
B) define.xml
C) acrf.pdf
D) specs.xml
2. 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";
3. A Statistical Analysis Plan defines study day as the number of days between the visit date and the date of randomization plus one day.
The following SAS program is submitted using a macro from the project's library:
How is the STUDYDAY macro defined?
A) %MACRO studyday(visit=, rand=);
&visit. ?&rand. + 1
%MEND studyday;
B) %MACRO studyday(rand, visit);
&visit. ?&rand. + 1
%MEND studyday;
C) %MACRO studyday(rand, visit);
&vdt. ?&rdt. + 1
%MEND studyday;
D) %MACRO studyday(rand=, visit=);
&vdt. ?&rdt. + 1
%MEND studyday;
4. Which date is presented using an ISO-8601 format?
A) 17/01/1980
B) 01/17/1980
C) 17JAN1980
D) 19800117
5. A Statistical Analysis Plan (SAP) defines the selection process for baseline records. This instructs the programmer to choose the last non-missing analyte value prior to first study drug administration (date/time).
The DEMO data set contains the date/time of first study drug administration for subject:
What will be the resulting baseline values, as selected per the SAP instructions?
A) Option B
B) Option D
C) Option C
D) Option A
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: C | Question # 3 Answer: B | Question # 4 Answer: D | Question # 5 Answer: B |
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