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A00-280 Examination questions (September)

Achieve New Updated (September) SAS A00-280 Examination questions 1-10

September 25, 2015

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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:

 

clip_image002

 

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 ;

 

Answer: C

 

 

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

 

Answer: D

 

 

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

 

Answer: D

 

 

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

 

Answer: B

 

 

 

QUESTION 5

Given the following data set (AE):

 

clip_image004

 

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 ;

 

 

 

 

 

Answer: A

 

 

QUESTION 6

Given the SAS data set containing subject’s phone numbers

 

clip_image006

 

What is the value of PHONE2 for subject 005?

 

A.

(215) 631-9494

B.

2156319494

C.

(215) 6319494

D.

631-9494

 

Answer: B

 

 

QUESTION 7

The following SAS program is submitted.

 

 

 

 

 

clip_image008

 

What result is displayed for the variable COUNT?

 

A.

1

B.

2

C.

3C.3

D.

4D.4

 

Answer: C

 

 

QUESTION 8

The following SAS program is submitted:

 

 

 

 

 

clip_image010

 

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;

 

Answer: C

 

 

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)

 

Answer: B

 

 

QUESTION 10

Study day is defined as DCMDATE minus RFSTDTC +1

 

 

 

 

 

clip_image012

 

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;

 

Answer: C

 

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