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SASInstitute Clinical Trials Programming Using SAS 9.4 Sample Questions:

1. Study day is defined as DCMDATE minus RFSTDTC +1

Which statement will compute the study day correctly without producing notes for missing values in the log?

A) If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,date9.)- input(RFSTDTC,yymmdd8.)+1;
B) STUDYDAY=input(DCMDATE,yymmdd8.)-input(RFSTDTC,date9.)+1;
C) STUDYDAY=DCMDATE-RFSTDTC+1;
D) If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,yymmdd8.)- input(RFSTDTC,date9.)+1;

2. What is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects

A) MedDRA
B) WHODrug
C) 21 CFR Part 11
D) Good Clinical Practices

3. Review the following procedure format:

What is the required type of data for the variable in this procedure?

A) Character
B) Categorical
C) Continuous
D) Treatment

4. Given the following SCORE data set:

Based on the concept of Last Observation Carried Forward, what will be the value for SCORE for the Week 12 -

A) 153
B) 152
C) 157
D) missing

5. A Treatment-Emergent Adverse Event (TEAE) is commonly defined as any event that occurs on or after the date and time of:

A) first dose of study drug
B) informed consent
C) study enrollment
D) baseline assessment

Solutions: