A00-281

(1)

SAS Institute A00-281

Clinical Trials Programming Using SAS 9 –

Accelerated Version

(2)

QUESTION NO: 1

Given the following data at WORK DEMO:

Which SAS program prints only the first 5 males in this order from the data set?

A.

proc sort data=WORK.DEMO out=out; by sex;

run;

proc print data= out (obs=5); run;

B.

proc print data=WORK.DEMO(obs=5); where Sex='M';

run;

C.

proc print data=WORK.DEMO(where=(sex='M')); where obs<=5;

run;

D.

proc sort data=WORK.DEMO out=out; by sex descending;

run;

proc print data= out (obs=5); run;

(3)

Explanation:

QUESTION NO: 2

Which SAS program will apply the data set label 'Demographics' to the data set named DEMO?

A.

data demo (label='Demographics'); set demo;

run;

B.

data demo;

set demo (label='Demographics'); run;

C.

data demo (label 'Demographics'); set demo;

run;

D.

data demo; set demo;

label demo= 'Demographics'; run;

Answer: A Explanation:

QUESTION NO: 3

The following SAS program is submitted:

proc sort data=SASUSER.VISIT out=PSORT; by code descending date cost;

run;

Which statement is true regarding the submitted program?

(4)

B. The variable CODE is sorted by ascending order. C. The PSORT data set is stored in the SASUSER library.

D. The descending option applies to the DATE and COST variables. Answer: B

Explanation:

QUESTION NO: 4

What information can be found in the SAS Dictionary tables? (Choose two.)

A. datasets contained within a specified library B. values contained within a specified format C. variables contained within a specified dataset D. values contained within a specified variable Answer: A,C

Explanation:

QUESTION NO: 5

(5)

Which program was used to prepare the data for this PROC PRINT output?

A.

proc sort data=one out=two; by subjid;

run;

B.

proc sort data=one out=two nodupkey; by subjid;

run;

C.

proc sort data=one out=two nodup; by subjid;

run;

D.

proc sort data=one out=two nodupkey; by subjid trt;

run;

Answer: B Explanation:

QUESTION NO: 6

This question will ask you to provide a line of missing code.

(6)

Which statement is required to produce this output?

A. TABLES site*group /nocol; B. TABLES site*group /norow; C. TABLES site*group;

D. TABLES site*group /nocol norow;D. TABLES site*group /nocol norow; Answer: A

Explanation:

QUESTION NO: 7

Which statement correctly adds a label to the data set?

A.

DATA two Label="Subjects having duplicate observations"; set one;

(7)

B.

DATA two;

Label="Subjects having duplicate observations"; set one;

run;

C.

DATA two; set one;

Label dataset="Subjects having duplicate observations"; run;

D.

DATA two(Label="Subjects having duplicate observations"); set one;

run;

Answer: D Explanation:

QUESTION NO: 8

Given the following data set:

Which SAS program produced this output?

(8)

proc sort data=one(where=(age>50)) out=two; by subjid;

run;

B.

proc sort data=one(if=(age>50)) out=two; by subjid;

run;

C.

proc sort data=one out=two; where=(age>50);

by subjid; run;

D.

proc sort data=one out=two; if age>50;

by subjid; run;

QUESTION NO: 9 CORRECT TEXT

The following question will ask you to provide a line of missing code.

The following program is submitted to output observations from data set ONE that have more than one record per patient.

In the space below, enter the line of code that will correctly complete the program (Case is ignored. Do not add leading or trailing spaces to your answer.).

(9)

Answer: BYSUBJID; BYSUBJID;

QUESTION NO: 10

Given the data set WORK.BP with the following variable list:

(10)

A. Option A B. Option B C. Option C D. Option D

(11)

QUESTION NO: 11

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

Explanation:

QUESTION NO: 12

Which program will report all created output objects in the log?

A.

proc ttest data=WORK.DATA1 ods=trace; class TREAT;

var RESULTS; run;

B.

ods trace on;

proc ttest data=WORK.DATA1; class TREAT;

(12)

run;

C.

ods trace=log;

proc ttest data=WORK.DATA1; class TREAT;

var RESULTS; run;

D.

ods trace log;

proc ttest data=WORK.DATA1; class TREAT; var RESULTS; run; Answer: B Explanation: QUESTION NO: 13

Review the following procedure format:

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

A. Character B. Continuous C. Categorical D. Treatment Answer: B Explanation: QUESTION NO: 14

(13)

Which SAS program created this output?

A.

proc freq data=WORK.TESTDATA;

tables gender * answer / nocol norow nopercent; run;

B.

tables answer * gender / nocol norow nopercent; run;

C.

tables gender * answer / nocol norow nopercent missing; run;

D.

tables answer * gender / nocol norow nopercent missing; run;

QUESTION NO: 15

You want 90% confidence limits for a binomial proportion from a one-way table with PROC FREQ. Which option must you add to the TABLES statement?

A. BINOMIAL

(14)

C. BINOMIAL ALPHA=90 D. BINOMIAL ALPHA=0.1 Answer: D

Explanation:

QUESTION NO: 16

The following SAS program is submitted.

What result is displayed for the variable COUNT?

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

(15)

Answer: C Explanation:

QUESTION NO: 17

Given the following output from the TTEST Procedure: Variable:

What is the t-test p-value?

A. 0.3121 B. <.0001 C. 37.49 D. 0.2041 Answer: B Explanation: QUESTION NO: 18

You want to calculate the p-value of Fisher's exact test for a 3x3 table. Which option must you add to the TABLES statement of PROC FREQ?

A. CHISQ B. CMH C. EXACT D. EXPECTED

(16)

QUESTION NO: 19

How many data sets are created and how many observations are in the data set(s)?

A. 1 data set named PVALUES with 1 observation. B. 1 data set named PVALUES with 2 observations.

C. 2 data sets named PVALUES and PVALUES1 each with 1 observation. D. 2 data sets named PVALUES1 and PVALUES2 each with 2 observations Answer: C

Explanation:

QUESTION NO: 20

(17)

Which line of code would produce the blue notes in the log?

A. if indm ne indisp then output 'MERGE ISSUE: ' subjid indm indisp ; B. if indm ne indisp then put 'MERGE ISSUE: ' subjid= indm= indisp=; C. %if indm ne indisp %then %put 'MERGE ISSUE: ' subjid= indm= indisp=; D. if indm ne indisp then put 'MERGE ISSUE: ' _all_ ;

QUESTION NO: 21

Which option for PROC COMPARE will list all observations and variables found in only one of the two data sets being compared?

A. LISTALL B. OUTALL C. ALLOBS D. OUTDIFF Answer: A Explanation: QUESTION NO: 22

(18)

Which SAS system option adds the blue highlighted lines to the log? A. INFO B. MSGLEVEL=I C. INVALIDDATA='I' D. NOTES Answer: B Explanation: QUESTION NO: 23

A SAS report procedure results in the log below.

What should you add to the PROC REPORT to address the blue note in this log?

A. Use DEFINE statements with the WIDTH= option set large enough to print all values for each

variable

B. Specify COLWIDTH= option with a value large enough to print all values in the data C. Use DEFINE statements where FLOW is specified for each numeric variable

(19)

variable

QUESTION NO: 24

Which validation technique involves two programmers writing separate programs to produce the same output, then comparing the result?

A. Independent Programming B. Peer Matching C. Identical Programming D. Peer Review Answer: A Explanation: QUESTION NO: 25

A SAS program is submitted and the following log is written.

What is the cause of this error message?

A. The ARRAY declaration is syntactically incorrect. B. The IF statement is syntactically incorrect.

C. The DO loop tries to get a value from a variable which does not exist. D. The IF statement tries to get ARRAY elements which are not declared. Answer: D

(20)

QUESTION NO: 26

If the value for the variable Subjcode is "WGT2", what is the value of the variable Description?

A. missing character value B. Unknown C. Over D. Wgt2 Answer: B Explanation: QUESTION NO: 27

(21)

Why is the blue note showing in the log?

A. The variable VISIT occurs in both data sets but is not included in the BY statement. B. There are no observations with matching values for SUBJID in either data set. C. There are multiple observations with the same value for SUBJID in both data sets. D. One of the two data sets has multiple observations with the same value for SUBJID. Answer: C

Explanation:

QUESTION NO: 28

The following SAS program is submitted, but fails due to syntax errors.

What is the cause of the syntax errors?

A. The keep= data set option should be (keep=MonthExp*).

B. An array can only be referenced in a KEEP statement and not within a keep= data set option. C. An array cannot be referenced on a keep= data set option.

D. The keep= data set option should be (keep=MonthExp). Answer: C

Explanation:

QUESTION NO: 29

(22)

Which selection below would be considered hard-coding?

A.

if sexcd eq 1 then sex = "Male" ;

else if sexcd eq 2 then sex = "Female" ;

B.

if site eq 1 then sexcd = 2 ; else if site eq 2 then sexcd = 1 ;

C.

if site eq 1 and sexcd ne 2 then check = 1 ; else if site eq 2 and sexcd ne 1 then check = 2 ;

D.

birthdt = input(dob, mmddyy10.) ;

QUESTION NO: 30

(23)

Which option would you need to add to the INFILE statement to clear the notes from this log? A. firstobs=2 B. missover C. lrecl=2 D. start=2 Answer: A Explanation: QUESTION NO: 31

Given the following entry in the SAS log:

(24)

• Transpose all data

• Not produce a warning message in the log

A. Use PROC TRANSPOSE with a WHERE clause to omit records with missing VISIT values B. Use PROC COPY with SELECT statements

C. Use PROC DATASETS with SELECT and MODIFY statements D. Use a DATA step with conditional OUTPUT statements

QUESTION NO: 32

Given the following partial output data set:

Which code was used to create AGECAT?

A.

if age <18 then AGECAT=1;

if 18<=AGE<=40 then AGECAT=2; else AGECAT=3;

B.

if age <=18 then do AGECAT=1;

else if 18<AGE<=40 then do AGECAT=2; else do AGECAT=3;

C.

if age <18 then AGECAT=1;

else if 18<=AGE<=40 then AGECAT=2; else AGECAT=3;

D.

if age <=18 then AGECAT=1;

else if 18<AGE<=40 then AGECAT=2; else AGECAT=3;

(25)

QUESTION NO: 33

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

A. DayofMonth, Year, and MonthofYear are character. B. DayofMonth, Year, and MonthofYear are numeric.

C. DayofMonth and Year are numeric. MonthofYear is character D. DayofMonth, Year, and MonthofYear are date values

QUESTION NO: 34

Given the following data set (AE):

(26)

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 NO: 35

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?

(27)

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;

QUESTION NO: 36

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

Explanation:

The following question will ask you to provide a line of missing code.

Given the following data set work.vs:

The following SAS program is submitted to create a new data set that carries forward the previous value of sbp when the value is missing.

(28)

In the space below, enter the line of code that completes the program (Case is ignored. Do not add leading or trailing spaces to your answer.).

Answer: RETAINOLD_SBP;,RETAINOLD_SBP;

QUESTION NO: 38

This question will ask you to provide a section of missing code.

(29)

Which DO LOOP will create the output SAS data set WORK.LAB_NEW? A. do i=1 to 2; visit=i; date=dat{i}; result=num{i}; output; end; B. do i=1 to 2; visit=i; date=dat{i}; result=num{i}; end; output; C. do i=1 to 2; do j=1 to 2; visit=i; date=dat{j}; result=num{j}; output; end; D. do i=1 to 2; do j=1 to 2; visit=i; date=dat{j}; result=num{j}; end; output; end; Answer: A Explanation: QUESTION NO: 39

(30)

Based on the concept of Last Observation Carried Forward, what will be the value for SCORE for the Week 12 A. 157 B. 152 C. missing D. 151 Answer: A Explanation: QUESTION NO: 40

What is the value of the variable day when the data step completes?

A. 1 B. 6 C. 7 D. 8 Answer: D Explanation:

(31)

QUESTION NO: 41

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 Answer: B Explanation: QUESTION NO: 42

(32)

Baseline is defined as the last non-missing value prior to Day 1.

What is the value for the change from baseline for Week 1 for Subject 2?

A. -23 B. 11 C. -11 D. 23 Answer: C Explanation:

(33)

In the space below, enter the statement that completes the program to produce the desired output (Case is ignored. Do not add leading or trailing spaces to your answer.).

Answer: IDLABTEST;,IDLABTEST;,IDLABTEST

QUESTION NO: 44

Given the following data set WORK.DM:

(34)

A. 001 and 004 B. 001 and 006 C. 003 and 004 D. 004 and 006 Answer: D Explanation: QUESTION NO: 45

This question will ask you to provide lines of missing code.

Given the following SCORE data set:

(35)

on last observation carried forward method). Which SAS statements complete the program?

A.

LOCF = lag(score) ;

if first.subject then LOCF = . ; if score ^= . then LOCF = score ;

B.

if first.subject then LOCF = . ;

if score = . then LOCF = lag(score) ;

C.

retain LOCF ;

D.

retain score ;

QUESTION NO: 46

Which function would be used to determine the number of elements in an existing array?

A. dim () B. n () C. sum () D. count () Answer: A Explanation:

(36)

In the space below, enter the numeric value of x for "Severe" events under HEADACHE.

Answer: 2

QUESTION NO: 48

Which value does variable X contain?

A. the numeric value 0

B. the character value "01Jan1960" C. the date value 01011960

(37)

D. the code contains a syntax error and does not execute. Answer: A

Explanation:

QUESTION NO: 49

Given the dataset RAWBP that is sorted by SUBJECT TEST WEEK:

Which statement must be added to the program to calculate relative change in percent (percent change) from baseline?

A. pct_chg = ((baseline - value) /baseline)*100; B. pct_chg = ((value - baseline) /baseline)*100; C. pct_chg = ((baseline - value) /value)*100; D. pct_chg = ((value - baseline) /value)*100; Answer: B

(38)

QUESTION NO: 50

Which statement correctly creates a SAS date variable from a character variable?

A. sasdate = input(chardate,date9.); B. sasdate = 'chardate'd; C. sasdate = put(chardate,date9.); D. sasdate = date(chardate,date9.); Answer: A Explanation: QUESTION NO: 51

What is the value of the second variable in the data set WORK.DIGESTL?

A. diverticulosis B. divertic

C. a missing value

D. No variables are created. Answer: B

Explanation:

QUESTION NO: 52

(39)

What will be the result when the program executes?

A. num3 assigned a missing value B. num3 assigned a value of 0 C. num3 assigned a value of 1

D. An error due to mixed variable types in the assignment statement. Answer: A

Explanation:

QUESTION NO: 53

Given the SAS data set WORK.VS1:

Which value will be assigned to variable TOTAL?

A. missing B. 112 C. 140 D. 560 Answer: C Explanation:

(40)

QUESTION NO: 54

Given the data set HE:

What will the values be of variable HOSPDURD for the two subjects?

A. 5, missing B. missing, missing C. 65, 9 D. 50, 9 Answer: B Explanation: QUESTION NO: 55

(41)

A.

proc transpose data=vitals ; var pulse sysbp diabp ; run ;

B.

proc transpose data=vitals ; by patid visit ;

run ;

C.

proc transpose data=vitals ; var patid visit ;

run ;

D.

proc transpose data=vitals ; id patid visit ;

run ;

(42)

You have acquired an existing program from a coworker which uses a macro. It is not

immediately clear to you what this macro is doing. Which OPTION can be used to put the SAS statements generated by the macro execution into the LOG?

A. MPRINT B. SYMBOLGEN C. MLOGIC D. MRECALL Answer: A Explanation: QUESTION NO: 57

Which macro call prints all records from each dataset in library DB?

(43)

B. %printlib(lib=DB, rec= ) C. %printlib(DB, all) D. %printlib(DB, ) Answer: B Explanation: QUESTION NO: 58

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 ;

(44)

QUESTION NO: 59

Which clause allows macro variable creation on a select statement in PROC SQL?

A. INTO B. SYMPUT C. AS D. %MACRO Answer: D Explanation: QUESTION NO: 60

This question will ask you to provide a missing option.

Given an existing work data set (DM), the following code is submitted:

A. MPRINT B. SYMBOLGEN

(45)

C. MLOGIC D. MRECALL Answer: C Explanation:

QUESTION NO: 61

%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 Explanation: QUESTION NO: 62

Which statement assigns the current date to the character variable CURRDT?

A. currdt="&sysdate."; B. currdt="%sysdate."; C. currdt="sysdate."; D. currdt="#sysdate."; Answer: A Explanation:

(46)

You want to present a column header that contains breaks within the header as indicated below.

In the space below, enter the option that completes the program (Case is ignored. Do not add leading or trailing spaces to your answer).

Answer:

SPLIT='*';,SPLIT="*";,SPLIT='*',SPLIT="*",SPLIT='*';,SPLIT="*";,SPLIT='*',SPLIT="*",SPLIT='*';,S PLIT="*";,SPLIT='*',SPLIT="*",SPLIT='*';,SPLIT="*";,SPLIT='*',SPLIT="*"

QUESTION NO: 64

A report that you are working on will require the following header lines:

(47)

A. header2 'Adverse Events'; B. header2 = 'Adverse Events'; C. title2 = 'Adverse Events'; D. title2 'Adverse Events'; Answer: D

Explanation:

QUESTION NO: 65

This question will ask you to provide lines of missing code.

Which ODS statements, inserted respectively in the two locations indicated above, create a report stored in a PDF file?

A.

ods pdf open='AE.pdf'; ods pdf close;

B.

ods file open='AE.pdf' type=pdf; ods file close;

C.

ods pdf file='AE.pdf'; ods pdf close;

D.

ods file pdf='AE.pdf'; ods file close;

QUESTION NO: 66

(48)

Which program will generate a report where observations will appear in order by SITE SUBJECT and display column headers for each variable defined in the column statement?

A.

Proc Report ;

column site subject trt age gender race ; define site/'Site', subject/'Subject',

trt/'Treatment', age/'Age', gender/'Gender', race/'Race' ;

run;

B.

Proc Report ;

column site subject trt age gender race ; define site, subject, trt, age, gender, race ; by site subject ;

title 'Site Subject Treatment Age Gender Race' ; run;

C.

Proc Report ;

column site subject trt age gender race ; define site/order 'Site' ;

define subject/order 'Subject' ; define trt/'Treatment' ; define age/'Age' ; define gender/'Gender' ; define race/'Race' ; run; D. Proc Report ;

column site subject trt age gender race ; define site/order style(header)={'Site'} ;

define subject/order style(header)={'Subject'} ; define trt/style(header)={'Treatment'} ;

define age/style(header)={'Age'} ;

define gender/style(header)={'Gender'} ; define race/style(header)={'Race'} ;

(49)

run;

QUESTION NO: 67

Which statement will produce report output that can be opened in Microsoft Word?

A. ods rtf file='report.rtf'; B. ods doc file='report.doc';

C. ods type='word' file='report.doc'; D. ods rtf='report.rtf';

QUESTION NO: 68

Which statement will create a report footnote that identifies the date and time that the SAS program was executed?

A. footnote1 "Created on &sysdate9 &systime"; B. footnote1 = "Created on &sysdate9 &systime"; C. footnote1 'Created on &sysdate9 &systime'; D. footnote1 = 'Created on &sysdate9 &systime'; Answer: A

Explanation:

(50)

In the space below, enter the statement that completes the program correctly (Case is ignored. Do not add leading or trailing spaces to your answer.).

Answer:

DEFINESITE/ORDERNOPRINT;,DEFINESITE/NOPRINTORDER;,DEFINESITE/ORDERNOPRIN T;,DEFINESITE/NOPRINTORDER;,DEFINESITE/ORDERNOPRINT;,DEFINESITE/NOPRINTOR DER;,DEFINESITE/ORDERNOPRINT;,DEFINESITE/NOPRINTORDER;,DEFINE

QUESTION NO: 70

Which statement must be added to the following program to create a page break in the report after each RACE grouping?

(51)

A. break page / race; B. break race / page; C. break after race / page; D. break after race;

QUESTION NO: 71

The VISIT data set is multiple records per subject, sorted by usubjid vistdtc vistm and contains the following variables:

The DEATH data set is one record per subject, sorted by usubjid vistdtc vistm and contains the following variables:

(52)

A.

data data_1; merge death visit; by usubjid vistdtc vistm; run;

B.

data data_1; merge death visit; run;

C. data data_1;

set death visit;

by usubjid vistdtc vistm; run;

D.

data data_1; merge death visit; by usubjid vistm vistdtc; run;

QUESTION NO: 72

Which LIBNAME statement is valid?

A. libname "c:\sas\labdata\";

B. libname mysasdata "c:\sas\labdata\"; C. libname work "c:\sas\labdata\"; D. libname sasdata "c:\sas\labdata\"; Answer: D

Explanation:

QUESTION NO: 73

Which name is a valid SAS V5 variable name?

A. _AESTDTC B. AESTARTDTC C. AE-STDTC

(53)

D. AE_START_DTC Answer: A

Explanation:

QUESTION NO: 74

You have been asked to import an Excel spreadsheet. What will lead to substantial differences between the original Excel spreadsheet and the resulting SAS data set?

A. the number of rows to be read from the Excel file B. the number of columns to be read from the Excel file C. multiple value types within a single column

D. multiple value types within a single row Answer: C

Explanation:

QUESTION NO: 75

The following SAS program is submitted: data WORK.ALL;

How will the data sets ONE and TWO be combined?

A. updated B. one-one merged C. match merged D. concatenated Answer: D Explanation:

(54)

QUESTION NO: 76

The data set CM has eight variables including CMTRT and is sorted by STUDYID USUBJID CMSEQ.

DATA_BB is created by selecting records from CM where the character string "BLOCKER" is included in CMTRT.

Which program was used to produce WORK.DATA_BB?

A.

proc sort data=cm out=data_bb (keep=usubjid cmstdtc cmtrt); by usubjid CMSTDTC;

where cmtrt in('BLOCKER'); run;

B.

proc sort data=CM (keep=usubjid cmstdtc cmtrt) out=data_bb; by usubjid CMSTDTC;

where cmtrt contains 'BLOCKER'; run; C. data data_bb; set cm (where=(find(cmtrt,'BLOCKER','i')>0)); by usubjid CMSTDTC; run; D. data data_bb; set cm (keep=usubjid cmstdtc cmtrt); by usubjid CMSTDTC; where cmtrt in('BLOCKER'); run; Answer: B Explanation:

(55)

QUESTION NO: 77

Given the following two data sets EX and AE:

(56)

A. Option A B. Option B C. Option C D. Option D Answer: B Explanation: QUESTION NO: 78

(57)

What is the result?

A.

WORK.HIGHBP has 1 observation WORK.NORMBP has 1 observation WORK.INVESTBP has 3 observations

B.

C.

D.

WORK.HIGHBP has 2 observations WORK.NORMBP has 2 observations WORK.INVESTBP has 3 observations

(58)

Which alternative program creates an equivalent BASE_BP data set?

A.

proc sort data=VS (keep=usubjid vsstresn vstestcd) out=BASE_BP (drop=vstestcd);

where vstestcd in('DIABP','SYSBP'); by usubjid;

run;

B.

data BASE_BP;

set VS (keep=usubjid vsstresn); if vstestcd in('DIABP','SYSBP'); run;

C.

proc sort data=VS (keep=usubjid vsstresn vstestcd) out=BASE_BP (drop=vstestcd);

by usubjid;

if vstestcd in('DIABP','SYSBP'); run;

D.

data BASE_BP (keep=usubjid vsstresn vstestcd); set VS (drop=vstestcd); if vstestcd in('DIABP','SYSBP'); run; Answer: A Explanation: QUESTION NO: 80

This question will ask you to provide a missing option.

(59)

Which option will limit the files that are copied to type data? A. intype=data B. memtype=data C. entrytype=data D. include=data Answer: B Explanation: QUESTION NO: 81

Given the following data set:

Which type of clinical trials data is this?

A. Demographics B. Laboratory C. Medical History D. Vital Signs Answer: D Explanation: QUESTION NO: 82

(60)

• Contains one or more records per subject, per analysis parameter, and per analysis timepoint. • May be derived from findings, events, interventions and special-purpose SDTM domains, or other ADaM datasets.

• A record can represent an observed, derived, or imputed value required for analysis.

A. General Data Structure (GDS) B. Basic Data Structure (BDS)

C. Subject Level Analysis Data Set (ADSL) D. Event Level Analysis Data Set (ADAE) Answer: B

Explanation:

QUESTION NO: 83

Define.xml is an XML-based submission of a clinical study's:

A. results B. metadata C. data D. protocol Answer: B Explanation: QUESTION NO: 84

A subject reports a medication started in March of 2007 but cannot recall the day number. What is the value stored in the SDTM domain CM.CMSTDTC variable?

A. 00MAR2007 B. 2007 03 C. MAR2007 D. 2007-03 Answer: D Explanation:

(61)

QUESTION NO: 85

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 NO: 86

Which CDISC standard is concerned with the development of simplified case report forms?

A. Clinical Data Acquisition Standards Harmonization (CDASH) B. Operational Data Model (ODM)

C. Study Data Tabulation Model (SDTM) D. Trial Design Model (TDM)

QUESTION NO: 87

(62)

Which type of clinical trials data is this? A. Laboratory B. Baseline C. Medical History D. Vital Signs Answer: A Explanation: QUESTION NO: 88

The purpose of the ADaM model is to provide a framework that:

A. enables the tabulation of the raw source data B. enables the creation of study patient profiles C. enables the statistical analysis of the data D. can be used to generate the CDISC ODM Answer: C

Explanation:

QUESTION NO: 89

Where would you store a value collected on a case report form but not defined in an SDTM domain? A. RELREC B. DM C. SUPPQUAL D. SC Answer: C Explanation:

(63)

• Variable attributes • Controlled terminology • Computational methods

Enter your answer in the space below (Case is ignored. Do not add leading or trailing spaces to your answer.).

Answer: DEFINE.XML,DEFINE.PDF,DEFINE

QUESTION NO: 91

Which statement correctly describes an aspect of a Phase II clinical trial?

A. randomized controlled multicenter trials on large patient groups

B. designed to assess the pharmacovigilance, pharmacokinetics, and pharmacodynamics of a

drug

C. in vitro and in vivo experiments using wide-ranging doses of the drug D. designed to assess how well the drug works

QUESTION NO: 92

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).

(64)

What will be the resulting baseline values, as selected per the SAP instructions? A. Option A B. Option B C. Option C D. Option D Answer: D Explanation: QUESTION NO: 93

From the Statistical Analysis Plan, patients age is calculated as an integer relative to date randomized divided by 365.25. Given the following annotated CRF:

(65)

Which programming code defines the patient's age?

A. age = int((birthdt-randdt)/365.25); B. age = int((randdt-birthdt)/365.25);

C. age= int(yrdif(birthdt,randdt, "act/365.25" )); D. age = int((today()-birthdt)/365.25);

QUESTION NO: 94

An action plan that describes what will be done in a drug study, how it will be conducted, and why each part of the study is necessary is called:

A. a clinical trial plan B. a protocol

C. a data management plan D. a statistical analysis plan Answer: B

(66)

QUESTION NO: 95

What is the main focus of 21 CFR Part 11?

A. electronic submission requirements B. trial safety requirements

C. statistical calculation requirements D. trial protocol requirements

QUESTION NO: 96

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 Explanation:

QUESTION NO: 97

A patient received at least one dose of study medication prior to withdrawing from a study. Which analysis population would always include this patient?

A. efficacy B. intent to treat C. per protocol D. safety Answer: D Explanation:

(67)

QUESTION NO: 98

A Statistical Analysis Plan describes a clinical trial as "A 12 week, double-blind, placebo-controlled, randomized, multi-center study." Double-blind refers to which groups in this study?

A. treatment and control group B. investigator and subjects C. statistician and sponsor D. sponsor and investigator Answer: B

Explanation:

QUESTION NO: 99

Given the following SAS program:

Which statement correctly identifies invalid values in the variable TRT, if only the values 'A', B', 'C are valid?

A. if indexc(TRT, 'ABC') eq 0 then output; B. if index(TRT, 'ABC') eq 0 then output; C. if find(TRT, 'ABC') eq 0 then output; D. if indexw(TRT, 'ABC') eq 0 then output; Answer: A