Ensurepass

QUESTION 1

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(rand, visit) ; &vdt. ?&rdt. + 1 %MEND studyday ; B. %MACRO studyday(rand=, visit=) ; &vdt. ?&rdt. + 1 %MEND studyday ; C. %MACRO studyday(rand, visit) ; &visit. ?&rand. + 1 %MEND studyday ; D. %MACRO studyday(visit=, rand=) ; &visit. ?&rand. + 1 %MEND studyday ;

QUESTION 2

The following SAS program is submitted:

%let Av=age;

%macro LABD(Av=weight);

%let Av=gend; %mend;

%LABD(Av=height)

%put Av is &Av;

What will be written to the SAS log?

 A. Av is weight B. Av is gend C. Av is height D. Av is age

QUESTION 3

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

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

QUESTION 4

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

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

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

QUESTION 6

Given the SAS data set containing subject’s phone numbers What is the value of PHONE2 for subject 005?

 A. (215) 631-9494 B. 2156319494 C. (215) 6319494 D. 631-9494

QUESTION 7

The following SAS program is submitted. What result is displayed for the variable COUNT?

 A. 1 B. 2 C. 3C.3 D. 4D.4

QUESTION 8

The following SAS program is submitted: You want to store all calculated means and standard deviations in one SAS data set.

Which statement must be added to the program?

 A. output mean std; B. ods output mean=m1 m2 std=s1 s2; C. output out=WORK.RESULTS mean=m1 m2 std=s1 s2; D. ods output out=WORK.RESULTS mean=m1 m2 std=s1 s2;

QUESTION 9

Identify the CDISC model with the following characteristics:

?XML-based content and format standard

?facilitates the archive and interchange of the metadata and data for clinical research

?provides an accurate audit trail that is 21 CRF Part II compliant

 A. Analysis Data Model (ADaM) B. Operational Data Model (ODM) C. Study Data Tabulation Model (SDTM) D. Trial Design Model (TDM)

QUESTION 10

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