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The following SAS program is submitted:



Which types of variables are DayofMonth, MonthofYear, and Year?

  1. DayofMonth, Year, and MonthofYear are character.
  2. DayofMonth, Year, and MonthofYear are numeric.
  3. DayofMonth and Year are numeric. MonthofYear is character
  4. DayofMonth, Year, and MonthofYear are date values

Answer(s): B



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?

  1. if day > 14 then week = 3 ;
    else if day > 7 then week = 2 ;
    else if day > 0 then week = 1 ;
  2. if day > 0 then week = 1 ;
    else if day > 7 then week = 2 ;
    else if day > 14 then week = 3 ;
  3. select ;
    when (day > 0) week = 1 ;
    when (day > 7) week = 2 ;
    otherwise week = 3 ;
    end ;
  4. select ;
    when (day > 14) week = 3 ;
    when (day > 7) week = 2 ;
    otherwise week = 1 ;
    end ;

Answer(s): A



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?

  1. STUDYDAY=DCMDATE-RFSTDTC+1;
  2. STUDYDAY=input(DCMDATE,yymmdd8.)-input(RFSTDTC,date9.)+1;
  3. If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,yymmdd8.)-input(RFSTDTC,date9.)+1;
  4. If RFSTDTC^='' and length(DCMDATE)=8 then STUDYDAY=input(DCMDATE,date9.)-input(RFSTDTC,yymmdd8.)+1;

Answer(s): C



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

  1. informed consent
  2. baseline assessment
  3. study enrollment
  4. first dose of study drug

Answer(s): D






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