Renuka

1. What is baseline and how will you derive the Baseline flag? SAS code
2. Main variables in SDTM.DM domain. Difference between Rfstdtc and rfxstdtc
3. Difference between EX and EC domains.
4. Difference between defining SAS macro variables via %let and call symput?
5. If leap year is there how do you impute dates.
6. Dataset has two variables (Name and Val). Name variable values have to be stored as macro names and Val variable va
call symput.
7. What is Treatment emergent flag and how will derive it?
8. Suppose a subject having fever around 100 degrees before the study drug administration, can this be considered as TEA
9. Common errors in SDTM Pinnacle Report (Open CDISC Report).
10. Explain when will you consider new variables like PARAMTYP, DTYPE & BASETYP in ADaMs
11. What is an epoch and how do you derive it.
12. What are the debugging options for macros? Explain them.
13. What is APERIOD and APHASE? How do you derive them?
14. Difference between analysis flag and criteria flag
15. Differences between SDTM and ADaM Population and Baseline Flags
16. Imputation methods for AVAL (missing), there derivations and sas code.
17. ADAM 1.0 and 1.1 differences.
18. Difference between Range/severity indicator variables and toxicity variables. Derivation.
19. Difference between INTNX and INTCK functions
20. How do we use SAS function inside a SAS macro?
21. Explain and draw mock of shift table and what is the purpose of shift table.
22. How do you validate tables and listings? What are some your validation findings?
23. How do you create TS domain? Explain the important variables of TS domain.

24. In a listing, for one SOC you have 10 different Preferred Terms and those were flowing to the next page. What will you d

25. What is the difference in structure of ADEG & ADAE.

26. What are the CDISC controlled terminology variables in DS
27. What is lookup table.
28. How to read special characters in macro
29. How do you create RELREC domain? What is its significance?
30. Explain SUBSTR right and left functions.
31. Where is death information captured in AE domain
32. What are the values of LBNRIND?
33. What is visit windowing? Explain
34. What is treatment emergent flag variable in ADAM? Difference between SDTM and ADAM treatment emergent flags?
35. Difference between defining SAS macro variables via proc sql and call symput?
36. What are the variables in SUPP dataset? When do we create SUPP domain?
37. What are the variables that you consider while merging supp and main datasets?
38. What are the different variables from AE that will be captured in SUPPAE?
39. Differences between TRANSLATE and TRANSWRD functions, their syntax.
40. What happens when you run TRANSPOSE procedure without ID statement?
41. Do you write specifications for SDTM, ADAM? What are documents you need to create specifications?
42. Explain the significance of compute statement?
What is your approach when something is found wrong in SAP / Shells?
43. What are the different types of AE tables that you have worked on?
44. Explain in brief about the maximum severity table for AE.
45. Scenario: when you have deliverables and timelines are stringent and you understand that you will not be able to subm
situation?
46. Difference between safety and efficacy analysis.
47. What is safety, ITT, per protocol, randomized populations? How you derive these flags?
48. Importance of original result variable and standard result variable in LB domain
49. What are bidirectional parameters?
50. Endpoints of current therapeutic area
51. Have you worked on oncology? If yes-What is time to event analysis? Explain the mock shell? Derivation of correspondi
52. In which context you use proc lifetest, syntax.
53. What is RECIST criteria? Explain
54. What oncology domains you have worked on?
55. Derivation of TRTSTDT and TRTENDTin parallel and cross over studies
56. What are ISS and ISE studies?
57. What kind of reports / work you noticed while working with ISS & ISE?
58. Have you worked on pooled studies? If yes, please explain
59. What are the challenges that you have faced while working on pooled studies?
60. How to remove a library?
61. If only one subject in the study, what would be the default statistics by using proc means
62. TS start rule and end rule
63. TA and TE relation
64. Difference between enrolment flag and full analysis set flag
65. How many ways to create macros. What are they?
66. Suppose you have AETERM & AEDECOD available and AEBODSYS is not available. What will you do in this scenario?
67. Explain how did you worked with CO Domain?
68. What is the difference between Serious Adverse Event & Severe Adverse Event, explain with an example?
69. I have a day value missing for MH start date, how will represent this value while creating SDTM MH
70. Why you didn’t impute date values in SDTM
71. What is the significance of SDTM SE ?
72. What is the topic variable of SE?
73. How will you consider the values of Test when Inclusion & Exclusion criteria length is more than 200?
74. What is define.xml & have you worked before on the same?
75. What are the different ADaM datasets that you have worked?
76. What are the challenges that you face whilst working with ADaMs?
77. Have ever created any study specific macros?
78. Have you ever worked on utility macros?
79. Explain for what are the cases that you have used utility macros
80. Do you ever get a chance for updating any utility macros? If so, what are updates that you have done 45. Have you invo
81. Have you involved in reviewing outputs?
82. What are the different ways that you follow while reviewing SDTM, ADaM & Outputs
83. What are the procedures that you have used while reporting the data?
84. How will you handle footnotes? What are the maximum footnotes that you can assign for a listing / table?
85. What is your approach of creating footnotes, if you have more than 10 footnotes for a listing / table?
86. Suppose if you have 200 pages of listing, how will you validate the same?
87. What are the different therapeutic areas you have worked?
88. What is the major difference between vaccines & drug related studies?
89. What are the challenges / differences you found between vaccines & drug related studies?

90. Have you ever worked on multiple studies at the same time? If yes situation when deliverables for 2 studies are close. H

91. Have you been part of training the people?

Renuka

1. What is baseline and how will you derive the Baseline flag? SAS code
2. Main variables in SDTM.DM domain. Difference between Rfstdtc and rfxstdtc
3. Which SDTM IG version used? Difference between EX and EC domains.
4. Difference between defining SAS macro variables via %let and call symput?
5. If leap year is there how do you impute dates.

6. Dataset has two variables (Name and Val). Name variable values have to be stored as macro
names and Val variable values have to be stored as macro values using call symput.

7. What is Treatment emergent flag and how will derive it?

8. Suppose a subject having fever around 100 degrees before the study drug administration,
can this be considered as TEAE?
9. Common errors in SDTM Pinnacle Report (Open CDISC Report).
10. Explain when will you consider new variables like PARAMTYP, DTYPE &
BASETYP in ADaMs
11. What is an epoch and how do you derive it.
12. What are the debugging options for macros? Explain them.
13. What is APERIOD and APHASE? How do you derive them?
14. Difference between analysis flag and criteria flag
15. Differences between SDTM and ADaM Population and Baseline Flags
16. Imputation methods for AVAL (missing), there derivations and sas code.
17. ADAM 1.0 and 1.1 differences.

18. Difference between Range/severity indicator variables and toxicity variables. Derivation.

19. Difference between INTNX and INTCK functions

20. How do we use SAS function inside a SAS macro?
21. Explain and draw mock of shift table and what is the purpose of shift table.
22. How do you validate tables and listings? What are some your validation findings?
23. How do you create TS domain? Explain the important variables of TS domain.
24. In a listing, for one SOC you have 10 different Preferred Terms and those were flowing to the
next page. What will you do for repeating the SOC to the next page?
25. What is the difference in structure of ADEG & ADAE.
26. What are the CDISC controlled terminology variables in DS
27. What is lookup table.
28. How to read special characters in macro
29. How do you create RELREC domain? What is its significance?
30. Explain SUBSTR right and left functions.
31. Where is death information captured in AE domain
32. What are the values of LBNRIND?
33. What is visit windowing? Explain
34. What is treatment emergent flag variable in ADAM? Difference between SDTM and ADAM
treatment emergent flags?
35. Difference between defining SAS macro variables via proc sql and call symput?
36. What are the variables in SUPP dataset? When do we create SUPP domain?
37. What are the variables that you consider while merging supp and main datasets?
38. What are the different variables from AE that will be captured in SUPPAE?
39. Differences between TRANSLATE and TRANSWRD functions, their syntax.
40. What happens when you run TRANSPOSE procedure without ID statement?
41. Do you write specifications for SDTM, ADAM? What are documents you need to create
specifications?
42. Explain the significance of compute statement?
What is your approach when something is found wrong in SAP / Shells?
43. What are the different types of AE tables that you have worked on?
44. Explain in brief about the maximum severity table for AE.

45. Scenario: when you have deliverables and timelines are stringent and you understand that
you will not be able to submit in time. How would you handle the situation?

46. Difference between safety and efficacy analysis.

47. What is safety, ITT, per protocol, randomized populations? How you derive these flags?

48. Importance of original result variable and standard result variable in LB domain
49. What are bidirectional parameters?
50. Endpoints of current therapeutic area
51. Have you worked on oncology? If yes-What is time to event analysis? Explain the mock
shell? Derivation of corresponding variables.
52. In which context you use proc lifetest, syntax.
53. What is RECIST criteria? Explain
54. What oncology domains you have worked on?
55. Derivation of TRTSTDT and TRTENDTin parallel and cross over studies
56. What are ISS and ISE studies?
57. What kind of reports / work you noticed while working with ISS & ISE?
58. Have you worked on pooled studies? If yes, please explain
59. What are the challenges that you have faced while working on pooled studies?
60. How to remove a library?

61. If only one subject in the study, what would be the default statistics by using proc means

62. TS start rule and end rule

63. TA and TE relation
64. Difference between enrolment flag and full analysis set flag
65. How many ways to create macros. What are they?
66. Suppose you have AETERM & AEDECOD available and AEBODSYS is not available. What will
you do in this scenario?
67. Explain how did you worked with CO Domain?
68. What is the difference between Serious Adverse Event & Severe Adverse Event, explain with
an example?
69. I have a day value missing for MH start date, how will represent this value while creating
SDTM MH
70. Why you didn’t impute date values in SDTM
71. What is the significance of SDTM SE ?
72. What is the topic variable of SE?
73. How will you consider the values of Test when Inclusion & Exclusion criteria length is more
than 200?
74. What is define.xml & have you worked before on the same?
75. What are the different ADaM datasets that you have worked?
76. What are the challenges that you face whilst working with ADaMs?
77. Have ever created any study specific macros?
78. Have you ever worked on utility macros?
79. Explain for what are the cases that you have used utility macros
80. Do you ever get a chance for updating any utility macros? If so, what are updates that you
have done
81. Have you involved in reviewing outputs? Have you involved in reviewing outputs?

82. What are the different ways that you follow while reviewing SDTM, ADaM & Outputs

83. What are the procedures that you have used while reporting the data?
84. How will you handle footnotes? What are the maximum footnotes that you can assign for a
listing / table?
85. What is your approach of creating footnotes, if you have more than 10 footnotes for a listing
/ table?
86. Suppose if you have 200 pages of listing, how will you validate the same?
87. What are the different therapeutic areas you have worked?
88. What is the major difference between vaccines & drug related studies?

89. What are the challenges / differences you found between vaccines & drug related studies?

90. Have you ever worked on multiple studies at the same time? If yes situation when
deliverables for 2 studies are close. How will you handle the situation?
91. Have you been part of training the people?
Below 4 Years 4 plus years 7 years+ 10 years+
Y Y Y Y
Y Y Y Y
Y Y Y Y
Y
Y

Y
Y

Y
N

N
N
Y
N
N
N
N
N

N
Y
y
N
N
N

Y
N
N
N
Y
Y
Y
y
Y
Y

N
Y
Y
Y
Y
Y
Y

N
Y
N
Y
Y

N
Y

Y
Y
N
Y

E
E
E
E
N
N
N
N
N
Y

Y
E
N
Y
Y

Y
Y

Y
Y
Y
Y

Y
N
N
N
N
N
N

N
N

N
Y

Y
Y
Y
N

N
N
Questions Basic
SDTM Y
What is baseline and how will you derive the Baseline flag? SAS code Y
Main variables in SDTM.DM domain. Y
Difference between Rfstdtc and rfxstdtc NA
Which SDTM IG version used? Difference between EX and EC domains. NA
If leap year is there how do you impute dates. NA
What is Treatment emergent flag and how will derive it? Y
Suppose a subject having fever around 100 degrees before the study drug administration, can this
be considered as TEAE? NA
Are you aware of OPEN CDISC Validator, what are the inputs to run the report? NA
Common errors in SDTM Pinnacle Report (Open CDISC Report). NA
What are acceptable issues in pinnacle21 report. NA
What is an epoch and how do you derive it. Y
Explain and draw mock of shift table and what is the purpose of shift table. NA
How do you create TS domain? Explain the important variables of TS domain. NA
What are the CDISC controlled terminology variables in DS Y
What is lookup table. NA
How do you create RELREC domain? What is its significance? Y
Where is death information captured in AE domain Y
What are the values of LBNRIND? Y
What is visit windowing? Explain Y
What are the variables in SUPP dataset? When do we create SUPP domain? Y
What are the variables that you consider while merging supp and main datasets? Y
What are the different variables from AE that will be captured in SUPPAE? Y

Do you write specifications for SDTM? What are documents you need to create specifications? NA
What are the different types of AE tables that you have worked on? Y
Explain in brief about the maximum severity table for AE. Y
Importance of original result variable and standard result variable in LB domain Y
TS start rule and end rule NA
TA and TE relation NA
Suppose you have AETERM & AEDECOD available and AEBODSYS is not available. What will you
do in this scenario? Y
Explain how did you worked with CO Domain? Y
What is the difference between Serious Adverse Event & Severe Adverse Event, explain with an
example? Y
I have a day value missing for MH start date, how will represent this value while creating SDTM
MH Y
Why you didn’t impute date values in SDTM Y
What is the significance of SDTM SE ? Y
What is the topic variable of SE? Y
How will you consider the values of Test when Inclusion & Exclusion criteria length is more than
200? NA
What are the different ways that you follow while reviewing SDTM NA
What is CDISC? Explain briefly why we need to follow CDISC in clinical domain? Y
What is SDTM, Classifications in SDTM? Y
Difference between Required, expected and permissible variables Y
What are General special purpose class? What all domains come under it? Y

What are events class? What is the topic variable? Name any two domains under this class? Y

What are findings domains? What is the topic variable? Name any two domains under this class Y
If you have only Protocol, what are the SDTM domains you can able to develop? Y
What are TDM’s and how are they are developed? NA
If any event that is Severe before taking treatment and it’s Mild after the treatment, will that be a
TEAE? Y
Difference between planned and actual Treatments? Y
If the subject is “Screen Failure”, what will be the ARM and AMRCD values? Y
How do we derive ARM and AMRCD? Y
If the subject is Randomized and not taken any treatment, what will be the ARM and AMRCD
values? Y
What are the values for IDVAR and IDVARVAL in SUPPDM? Y
Which are the SDTM Domains you need to start with? Y
What are the key variables in SV, and derivation of SVSTDTC and SEENDTC? Y

While deriving SVSTDTC if we have different dates for same visit, what you will do in that case? Y

What is the most complicated Domain in SDTM you came across, why? What was the complexity? Y
Can we add extra records to SDTM domain? If yes which domain and which variable is created to
denote the derived records Y
What are Unscheduled Visits and how to handle? Y
Study Day calculation? Y
Difference between study day and relative day
Difference between epoch vs element
Difference between SV vs TV
What is the use of SVUPDES variable in SV domain?
What is the purpose of populating VSLOC or LBLOC variables in SDTM datasets
What is your approach to create SV domain
Difference between SUPP and RELREC domains

ADAM Y

Explain when will you consider new variables like PARAMTYP, DTYPE & BASETYP in ADaMs NA
What is APERIOD and APHASE? How do you derive them? NA
Difference between analysis flag and criteria flag NA
Differences between SDTM and ADaM Population and Baseline Flags NA
Imputation methods for AVAL (missing), there derivations and sas code. NA
ADAM 1.0 and 1.1 differences. NA
Difference between Range/severity indicator variables and toxicity variables. Derivation. NA
What is the difference in structure of ADEG & ADAE. NA
What is treatment emergent flag variable in ADAM? Difference between SDTM and ADAM
treatment emergent flags? NA

Do you write specifications for ADAM? What are documents you need to create specifications? NA

What is safety, ITT, per protocol, randomized populations? How you derive these flags? Y
What are bidirectional parameters? NA
Derivation of TRTSTDT and TRTENDTin parallel and cross over studies NA
Difference between enrolment flag and full analysis set flag Y
What are the different ADaM datasets that you have worked? Y
What are the challenges that you face whilst working with ADaMs? Y
What are the different ways that you follow while reviewing ADaM NA
ADAM Classifications? Y
What are the Domains you have worked on? Y
What are the variables in ADSL.? Y
Different Population Flags in ADSL and their derivations.? Y
LOCF vs WOCF. In which variable do you populate these in ADaM
Have you ever worked on visit windowing? What is the approach for creating visit windowing?

How many data structures we have in ADaM IG 1.1 version?

How do you create last contact date for a subject?

TLF
How do you validate tables and listings? What are some your validation findings? Y
In a listing, for one SOC you have 10 different Preferred Terms and those were flowing to the next
page. What will you do for repeating the SOC to the next page? Y
What is your approach when something is found wrong in SAP / Shells? NA
In which context you use proc lifetest. NA
What kind of reports / work you noticed while working with ISS & ISE? NA

If only one subject in the study, what would be the default statistics by using proc means+A123 Y
Have you involved in reviewing outputs? Have you involved in reviewing outputs? NA
What are the different ways that you follow while reviewing Outputs NA
What are the procedures that you have used while reporting the data? Y
How will you handle footnotes? What are the maximum footnotes that you can assign for a
listing / table? Y
What is your approach of creating footnotes, if you have more than 10 footnotes for a listing /
table? Y
Suppose if you have 200 pages of listing, how will you validate the same? Y
Difference between Tables and Listings.? Y
What are the Tables have you worked on.? Y
How to calculate Header Counts.? Y
What are the procedures used for Categorical data.? Y
What are the procedures used for continuous data.? Y
How did you calculate percentages in tables Y

How to calculate No of Events in AE reports? And how to will differ from No of Subjects.? Y
If a subject has 2 Events, what will be the count for No of Events and No of subjects.? Y
If SOC count is 5 and PT count is 6, have you seen such scenarios? Y
What are the reports you have worked for LB? Y
Have you worked on Change From Baseline Tables, what are they? Y
If we have 20 Columns for Listings and if we want to print some of the columns to the next page,
how will do that? Y
How to print text before the Header Line? Y
What is population flag will be used for Efficacy analysis? Y
Can you please explain ISS and ISE. What type of challenges you faced while creating ISS/ISE
datasets? NA
What is Interim analysis? What are the advantages of Interim analyis Y
Have you ever worked on DSUR and PSUR? what is the purpose of DSUR & PSUR? NA
Can you please explain LAB shift table? Which variables do you consider from ADLB to create LAB
shift table Y

Difference between ITT vs FAS Y

How did you validate TFL's? Which validation procedure you use to validate Y
where do you use meddra and who dictionaries? Y

Have you ever worked on Graphs? Which procedures have you used for generating grpahs? Y
Have you heard about misrandomization? Can you please explain NA

SAS-technical Y
Difference between defining SAS macro variables via %let and call symput? Y

Dataset has two variables (Name and Val). Name variable values have to be stored as macro
names and Val variable values have to be stored as macro values using call symput. Y
What are the debugging options for macros? Explain them. Y
Difference between INTNX and INTCK functions Y
How do we use SAS function inside a SAS macro? Y
How to read special characters in macro Y
Explain SUBSTR right and left functions. Y
Differences between TRANSLATE and TRANSWRD functions, their syntax. Y
What happens when you run TRANSPOSE procedure without ID statement? Y
Explain the significance of compute statement? Y
How to remove a library? Y
How many ways to create macros. What are they? Y
What is the difference between IF and where? Y
What all functions you have used? Explain any three? Y
What is the difference between mean function and Proc Means? Y
What is the use of IN operator? Y
What is the difference between index function and find function? Y
What is the use of first.varibale and last.variable? why you have used it? Y
Difference between SUM function and + operator? Y
How to make first letter of the string capital? Y
How to extract 200 characters from a string? Y
If I have a 100 variables in the dataset and I want to rename those in a single data step, how it is
done Y
How to check whether the variable is presented in the dataset or not? Y
Difference between call Symput and Call Symputx? Y
Macro Quoting functions and why you have used it? Y

Difference between SQL joins and Merge statement, which you felt more useful and why? Y
How to pick first and last values from a variable using Proc SQL? Y
Difference between defining SAS macro variables via proc sql and call symput? Y

How do you create zero-records (dummy records) using proc freq? which option you will use?
Explain the significance of _N_ and _ERROR_ automatic variables?
How do you extract last two letters of a string (Assuming that we don't know how many
characters we have in a string)
Which ODS statement will you use to close all ODS destinations?

Difference between round function and put function (Ex: 5.667-convert this number to 2 decimals
using round and put functions)

How do you detect an end of dataset while reading data using SET statement?

Explain INTCK function in detail?

What is the default length which scan function assigns to the target variable?
What is the difference between calculating the 'mean' using the mean function and PROC
MEANS?

I have 20 variables and I need to replace blank character as “NA” for all 20 variables? Is there any
method to replace all blanks as “NA”?

How do you check whether a dataset exist in library?

How do you check whether a variable exist in dataset?

Explain the significane of PROC COMPARE

How do you create blank output using PROC REPORT procedure?

How do you handle truncation of Character variable in PROC REPORT (Assuming that width of the
variable shouldn't be increased)
There are 50 datasets in a library. How do you rename all datasets using dataset name followed
by _old
OTHER Y
Scenario: when you have deliverables and timelines are stringent and you understand that you
will not be able to submit in time. How would you handle the situation? NA
Difference between safety and efficacy analysis. Y
Endpoints of current therapeutic area Y
Have you worked on oncology? If yes-What is time to event analysis? Explain the mock shell?
Derivation of corresponding variables. NA
What is RECIST criteria? Explain NA
What oncology domains you have worked on? NA
hat are ISS and ISE studies? NA
Have you worked on pooled studies? If yes, please explain NA
What are the challenges that you have faced while working on pooled studies? NA
What is define.xml & have you worked before on the same? NA
Have ever created any study specific macros? NA
Have you ever worked on utility macros? NA
Explain for what are the cases that you have used utility macros NA
Do you ever get a chance for updating any utility macros? If so, what are updates that you have
done NA
What are the different therapeutic areas you have worked? Y
What is the major difference between vaccines & drug related studies? NA

What are the challenges / differences you found between vaccines & drug related studies? NA
Have you ever worked on multiple studies at the same time? If yes situation when deliverables for
2 studies are close. How will you handle the situation? NA
Have you been part of training the people? NA
Intermediate Expertise
Y Y
Y Y
NA NA
Y NA
Y NA
Y NA
Y Y

Y NA
Y NA
Y NA
Y NA
Y Y
Y NA
NA Y
NA NA
Y NA
Y Y
Y Y
NA NA
NA NA
NA NA
NA NA
NA NA

Y Y
NA NA
NA NA
NA NA
NA Y
Y Y

NA NA
NA NA

NA NA

NA NA
NA NA
Y NA
Y NA

Y NA
NA Y
NA NA
NA NA
NA NA
NA NA

NA NA

NA NA
Y NA
Y Y

Y NA
NA NA
Y NA
Y NA

Y NA
NA NA
NA NA
Y NA

Y NA

Y Y

NA NA
Y NA
NA NA

Y Y

Y Y
Y Y
Y Y
Y Y
Y Y
Y Y
Y Y
Y Y

Y Y

Y Y

Y Y
Y Y
Y Y
Y NA
Y Y
Y Y
Y Y
Y NA
Y Y
Y NA
Y Y

Y Y

Y NA
Y Y
Y Y
NA Y

Y NA
Y Y
Y Y
Y NA

Y NA

Y NA
Y Y
NA NA
Y Y
NA NA
NA NA
NA NA
NA NA

Y NA
Y NA
Y NA
Y NA
Y NA

Y NA
Y NA
Y NA

Y Y
Y NA
Y Y

Y Y

Y NA
Y NA
Y Y

Y Y
Y Y

Y Y
Y NA

Y Y
Y NA
Y NA
Y NA
Y NA
Y NA
Y NA
Y NA
Y NA
Y NA
Y NA
NA NA
Y NA
Y NA
NA NA
Y NA
Y NA
Y NA
NA NA
NA NA

Y NA
Y NA
Y NA
Y NA

Y NA
Y NA
Y NA
Y Y

Y Y
Y Y
Y Y

Y Y
Y Y
Y Y
Y Y
Y Y
Y Y
Y Y
Y Y
Y Y
Y Y

Y Y
Y Y
Y Y

Y Y

Y Y
Y Y
Questions
SDTM
Which SDTM IG version used? What are the domains that you have worked in SDTM?

What is the most complicated Domain in SDTM you came across, why? What was the complexity?
What are the challenges that you have faced while working on SDTM?
How will you derive the Baseline flag? What is the purpose of baseline flag?
Difference between Rfstdtc and rfxstdtc, define the purpose etc ?
Difference between EX and EC domains. When do we capture EC. What is the purpose?
What is Treatment emergent flag and how will derive it?
How do you do the validation of SDTM datasets?

Are you aware of OPEN CDISC Validator/pinnacle, what are the inputs to run the report?
What is lookup table. Give some scenarios you handled?
How do you create RELREC domain? What is its significance?
Where is death information captured in AE domain. Reason of death is captured in which variable
in AE domain?

Do you write specifications for SDTM? What are documents you need to create specifications?
TA and TE relation
What is the significance of SDTM SE ?
What is the topic variable of SE?
How will you handle length is more than 200 characters in SDTM? Have you come across similar
situation in your experience. Specify domain?
Difference between --DTC and --STDTC?
Explain the relative timing variables? When to use STRF, ENRF and STRTPT, ENRTPT. What are the
values captured in these variables?
If you have only Protocol and no specifications which SDTM domains you can develop?
What are TDM’s and how they are developed?
Explain Serious Adverse Event & Severe Adverse Event with an example?
If any event that is Severe before taking treatment and it’s Mild after the treatment, will that be a
TEAE?

Other medically importand SAE data is captured in which variable in Adverse event domain?
If the subject is “Screen Failure”, what will be the ARM and AMRCD values?
How do we derive ARM and AMRCD?
If the subject is Randomized and not taken any treatment, what will be the ARM and AMRCD
values?
What are the key variables in SV, and derivation of SVSTDTC and SVENDTC?

While deriving SVSTDTC if we have different dates for same visit, what you will do in that case?
What are Unscheduled Visits and how to handle?
In what are all the cases you apply controlled terminology? Give some examples?
Common errors in SDTM Pinnacle Report (Open CDISC Report).
What are acceptable issues in pinnacle21 report.
What is an epoch and how do you derive it.

ADAM
What are the different ADaM datasets that you have worked?
What are the challenges that you face whilst working with ADaMs?

Explain when will you consider new variables like PARAMTYP, DTYPE & BASETYP in ADaMs
What is APERIOD and APHASE? How do you derive them?
How do you derive analysis flag and criteria flag? Difference between them?
Imputation methods for AVAL (missing), their derivations.
What is the concept of LOCF
ADAM 1.0 and 1.1 differences. Major difference?
Variables which can provide ranges or references of an event or a particular parameter
What is the difference in structure of ADEG & ADAE.
What is treatment emergent flag variable in ADAM? Difference between SDTM and ADAM
treatment emergent flags?
How will you validate ADaM datasets
Do you write specifications for ADAM? What are documents you need to create specifications?
What are population flags in ADAM? How you derive these flags?
What are bidirectional parameters?
Derivation of TRTSTDT and TRTENDTin parallel and cross over studies
What are the different ways that you follow while reviewing ADaM
ADAM Classifications?
What are the variables in ADSL.?
How do you derive last available or last known date variable and where?
How will calculate change from Baseline

TLF
What are the Tables have you worked on.?
How to calculate No of Events in AE reports? And how to will differ from No of Subjects.?
If a subject has 2 Events, what will be the count for No of Events and No of subjects.?
If number of subjects in SOC count is 5 and PT count is 6. ? Is this possible?
What are the reports you have worked for LB?
Have you worked on Change From Baseline Tables, what are they?
If we have 20 Columns for Listings and if we want to print some of the columns to the next page,
how will do that?
How to print text before the Header Line?
Explain and draw mock shell of shift table and what is the purpose of shift table.
What is population flag will be used for Efficacy analysis?
What are the procedures that you have used while reporting the data?
Difference between Tables and Listings.?
What are the common issues / problems that you faced before starting with developing
summaries & listings? How do you handle them?
In a listing, for one SOC you have 10 different Preferred Terms and those were flowing to the next
page. What will you do for repeating the SOC to the next page?
How will you handle footnotes? What are the maximum footnotes that you can assign for a
listing / table?
What is your approach of creating footnotes, if you have more than 10 footnotes for a listing /
table?
Suppose if you have 200 pages of listing, how will you validate the same?
How do you validate tables and listings? What are some of your validation findings?
What is your approach when something is found wrong in SAP / Shells?
What are IB reports?
Have you involved in reviewing outputs? What are the different ways that you follow while
reviewing Outputs

SAS-technical
Difference between defining SAS macro variables via %let and call symput?

Dataset has two variables (Name and Val). Name variable values have to be stored as macro
names and Val variable values have to be stored as macro values using call symput.
What are the debugging options for macros? Explain them.
Difference between INTNX and INTCK functions. Their application?
How do we use SAS function inside a SAS macro?
How to read special characters in macro
Explain SUBSTR right and left functions.
Differences between TRANSLATE and TRANSWRD functions, their syntax.
What happens when you run TRANSPOSE procedure without ID statement?
Explain the significance of compute statement?
How to remove a library?
How many ways to create macros. What are they?
What is the difference between IF and where?
What all functions you have used? Explain any three?
What is the difference between mean function and Proc Means?
What is the use of IN operator?
What is the difference between index function and find function?
What is the use of first.varibale and last.variable? why you have used it?
Difference between SUM function and + operator?
How to make first letter of the string capital?
How to extract 200 characters from a string?
If I have a 100 variables in the dataset and I want to rename those in a single data step, how it is
done
How to check whether the variable is presented in the dataset or not?
Difference between call Symput and Call Symputx?
Macro Quoting functions and why you have used it?

Difference between SQL joins and Merge statement, which you felt more useful and why?
How to pick first and last values from a variable using Proc SQL?
Difference between defining SAS macro variables via proc sql and call symput?
Basic imputation rules
If leap year is there how do you impute dates.
In which context you use proc lifetest.
%let mvar3=Vs;
%Macro
If we haveLoc3;
20 Columns for Listings and if we want to print some of the columns to the next page,
%Let mvar3=Mh;
how will do that?
%Mend;
Report first, last and middle records from the datasets.
%Loc3;
%Put value is &mvar3;

How does criterion option work in PROC COMPARE

OTHER
Brief your experience?
What are the different therapeutic areas you have worked?
Scenario: when you have deliverables and timelines are stringent and you understand that you will
not be able to submit in time. How would you handle the situation?
Difference between safety and efficacy analysis.
Endpoints of current therapeutic area
Have you worked on oncology? If yes-What is time to event analysis? Explain the mock shell?
Derivation of corresponding variables.
What is RECIST criteria? Explain
What oncology domains you have worked on?
What are ISS and ISE studies?
Have you worked on pooled studies? If yes, please explain
What are the challenges that you have faced while working on pooled studies?
What is define.xml & have you worked before on the same?
Have ever created any study specific macros?
Have you ever worked on utility macros?
Explain for what are the cases that you have used utility macros
Do you ever get a chance for updating any utility macros? If so, what are updates that you have
done
What are the different therapeutic areas you have worked?
What is the major difference between vaccines & drug related studies?

What are the challenges / differences you found between vaccines & drug related studies?
Have you ever worked on multiple studies at the same time? If yes situation when deliverables for
2 studies are close. How will you handle the situation?
Have you been part of training the people?
Questions
SDTM

What is CDISC? Explain briefly why we need to follow CDISC in clinical domain?
What is SDTM, Classifications in SDTM?
Difference between Required, expected and permissible variables
What are General special purpose class? What all domains come under it?
What are events class? What is the topic variable? Name any two domains under
this class?
What are the relative timing variables in SDTM v1.1? What is captured in these
variables?
What are findings domains? What is the topic variable? Name any two domains
under this class
What is the most complicated Domain in SDTM you came across, why? What was
the complexity?
Can we add extra records to SDTM domain? If yes which domain and which variable
is created to denote the derived records
What are Unscheduled Visits and how to handle?
Difference between --DTC and --STDTC?
Study Day calculation?
What is baseline and how will you derive the Baseline flag?
I have more than one record for subject in baseline? Which record do you take as
baseline?
Main variables in SDTM.DM domain.

If you have only Protocol, what are the SDTM domains you can able to develop?
If any event that is Severe before taking treatment and it’s Mild after the treatment,
will that be a TEAE?
Other medically importand SAE data is captured in which variable in Adverse event
domain?
Difference between planned and actual Treatments?

If the subject is “Screen Failure”, what will be the ARM and AMRCD values?
How do we derive ARM and AMRCD?
If the subject is Randomized and not taken any treatment, what will be the ARM
and AMRCD values?
Which are the SDTM Domains you need to start with?
What are the key variables in SV, and derivation of SVSTDTC and SEENDTC?
While deriving SVSTDTC if we have different dates for same visit, what you will do in
that case?
What is Treatment emergent flag and how will derive it?
What is an epoch?
What are the CDISC controlled terminology variables in DS
How do you create RELREC domain? What is its significance?
Where is death information captured in AE domain
What are the values of LBNRIND?
What is visit windowing? Explain

What are the variables in SUPP dataset? When do we create SUPP domain?
What are the variables that you consider while merging supp and main datasets?
What are the values for IDVAR and IDVARVAL in SUPPDM?
What are the different variables from AE that will be captured in SUPPAE?

Importance of original result variable and standard result variable in LB domain

Suppose you have AETERM & AEDECOD available and AEBODSYS is not available.
What will you do in this scenario?
Explain how did you worked with CO Domain?
What is the difference between Serious Adverse Event & Severe Adverse Event,
explain with an example?
I have a day value missing for MH start date, how will represent this value while
creating SDTM MH
Why you didn’t impute date values in SDTM
What is the significance of SDTM SE ?
What is the topic variable of SE?

ADAM
Have you worked on ADAM datasets? If yes, what are they?
What are the challenges that you face whilst working with ADaMs?
ADAM Classifications?
What is safety, ITT, per protocol, randomized populations? How you derive these
flags?
Difference between enrolment flag and full analysis set flag
What are the variables in ADSL.?
Different Population Flags in ADSL and their derivations.?

TLF
What are the Tables have you worked on.?
How to calculate Header Counts.?
What are the procedures used for Categorical data.?
What are the procedures used for continuous data.?
How did you calculate percentages in tables
What are the different types of AE tables that you have worked on?
Explain in brief about the maximum severity table for AE.
How to calculate No of Events in AE reports? And how will it differ from No of
Subjects.?
If a subject has 2 Events, what will be the count for No of Events and No of
subjects.?
If SOC count is 5 and PT count is 6, have you seen such scenarios?
What are the reports you have worked for LB?
Have you worked on Change From Baseline Tables, what are they?
How do you validate tables and listings? What are some your validation findings?

In a listing, for one SOC you have 10 different Preferred Terms and those were
flowing to the next page. What will you do for repeating the SOC to the next page?
If only one subject in the study, what would be the default statistics by using proc
means
What are the procedures that you have used while reporting the data?
How will you handle footnotes? What are the maximum footnotes that you can
assign for a listing / table?
What is your approach of creating footnotes, if you have more than 10 footnotes for
a listing / table?
Suppose if you have 200 pages of listing, how will you validate the same?
Difference between Tables and Listings.?
If we have 20 Columns for Listings and if we want to print some of the columns to
the next page, how will do that?
How to print text before the Header Line?
What is population flag will be used for Efficacy analysis?

SAS-technical
How to delete macro variable and existed macros
What is p-value? Explain it?
Can we use concatenation process for numeric variables?
What are errors and warning messages generally you find in log window, when you
work run merge process?
I have a dataset with 100 observations, each subject have 5 records? I want one
record per subject? How do you get?
How do you create two macro variable by capture first day from previous month
and last day from previous month?

Difference between defining SAS macro variables via %let and call symput?

Dataset has two variables (Name and Val). Name variable values have to be stored
as macro names and Val variable values have to be stored as macro values using call
symput.
What are the debugging options for macros? Explain them.
Difference between INTNX and INTCK functions
How do we use SAS function inside a SAS macro?
How to read special characters in macro
Explain SUBSTR right and left functions.
Differences between TRANSLATE and TRANSWRD functions, their syntax.

What happens when you run TRANSPOSE procedure without ID statement?

Explain the significance of compute statement?
How to remove a library?
How many ways to create macros. What are they?
What is the difference between IF and where?
What all functions you have used? Explain any three?
What is the difference between mean function and Proc Means?
What is the use of IN operator?
What is the difference between index function and find function?
What is the use of first.varibale and last.variable? why you have used it?
Difference between SUM function and + operator?
How to make first letter of the string capital?
How to extract 200 characters from a string?
If I have a 100 variables in the dataset and I want to rename those in a single data
step, how it is done
How to check whether the variable is presented in the dataset or not?
Difference between call Symput and Call Symputx?
Macro Quoting functions and why you have used it?
Difference between SQL joins and Merge statement, which you felt more useful and
why?
How to pick first and last values from a variable using Proc SQL?

Difference between defining SAS macro variables via proc sql and call symput?
Report first, last and middle records from the datasets.
Report first, last and middle records from the datasets.
What are the options used in proc compare?

OTHER
What are the different therapeutic areas you have worked?
Difference between safety and efficacy analysis.
Difference between endpoints and objectives?
Endpoints of current therapeutic area
What is SAP? Explain with example?
Washout period? Why we use washout period?
In which format the raw data will come in your organization?
Questions
SDTM
What is baseline and how will you derive the Baseline flag? SAS code
Difference between Rfstdtc and rfxstdtc
Which SDTM IG version used? Difference between EX and EC domains.
If leap year is there how do you impute dates.
What is Treatment emergent flag and how will derive it?
Suppose a subject having fever around 100 degrees before the study drug administration, can this be considered as TEAE?
Explain the relative timing variables? When to use STRF, ENRF and STRTPT, ENRTPT. Explain the context of use of these
variables in SDTM domains your worked on?
Are you aware of OPEN CDISC Validator, what are the inputs to run the report?
Common errors in SDTM Pinnacle Report (Open CDISC Report).
What are acceptable issues in pinnacle21 report.
What is an epoch and how do you derive it.
Explain and draw mock of shift table and what is the purpose of shift table.
What is lookup table.
How do you create RELREC domain? What is its significance?
Where is death information captured in AE domain
Do you write specifications for SDTM? What are documents you need to create specifications?
TA and TE relation
What is the significance of SDTM SE ?
What is the topic variable of SE?
How will you consider the values of Test when Inclusion & Exclusion criteria length is more than 200?
If you have only Protocol, what are the SDTM domains you can able to develop?
What are TDM’s and how they are developed?
When is TSVALNF populated in TS domain?
Give some examples of TSPARAMCD values?
If trial addresses both safety and efficacy , how many records are generated and what are the values of TSPARAMCD and
TSVAL?
If any event that is Severe before taking treatment and it’s Mild after the treatment, will that be a TEAE?
If the subject is “Screen Failure”, what will be the ARM and AMRCD values?
How do we derive ARM and AMRCD?
If the subject is Randomized and not taken any treatment, what will be the ARM and AMRCD values?
What are the key variables in SV, and derivation of SVSTDTC and SEENDTC?
While deriving SVSTDTC if we have different dates for same visit, what you will do in that case?
What is the most complicated Domain in SDTM you came across, why? What was the complexity?
What are Unscheduled Visits and how to handle?

ADAM
ADAM Classifications?
What are the Domains you have worked on?
What are the challenges that you face whilst working with ADaMs?
What are the variables in ADSL.?
Different Population Flags in ADSL and their derivations.?
Explain when will you consider new variables like PARAMTYP, DTYPE & BASETYP in ADaMs
What is APERIOD and APHASE? How do you derive them?
Difference between analysis flag and criteria flag
Differences between SDTM and ADaM Population and Baseline Flags
Imputation methods for AVAL (missing), there derivations and sas code.
ADAM 1.0 and 1.1 differences.
Difference between Range/severity indicator variables and toxicity variables. Derivation.
What is the difference in structure of ADEG & ADAE.

What is treatment emergent flag variable in ADAM? Difference between SDTM and ADAM treatment emergent flags?
How will you validate ADaM datasets?
Do you write specifications for ADAM? What are documents you need to create specifications?
What is safety, ITT, per protocol, randomized populations? How you derive these flags?
What are bidirectional parameters?
Derivation of TRTSTDT and TRTENDTin parallel and cross over studies
Difference between enrolment flag and full analysis set flag
What are the different ADaM datasets that you have worked?
What are the different ways that you follow while reviewing ADaM
Screen failure data, if submitted is include in which dataset? Explain its structure?
Common errors in ADAM Pinnacle Report (Open CDISC Report).
What are data point traceability variables? In which context you create these variables?

TLF
What are the Tables have you worked on.?
How to calculate No of Events in AE reports? And how to will differ from No of Subjects.?
If a subject has 2 Events, what will be the count for No of Events and No of subjects.?
If SOC count is 5 and PT count is 6, have you seen such scenarios?
How to print text before the Header Line?
What population flag will be used for Efficacy analysis?
Have you worked on SMQ tables? If yes what are they?
What are the reports you have worked for LB?
Have you worked on Change From Baseline Tables, what are they?
In which context you use proc lifetest.
How do you validate tables and listings? What are some your validation findings?
In a listing, for one SOC you have 10 different Preferred Terms and those were flowing to the next page. What will you do for
repeating the SOC to the next page?
What is your approach when something is found wrong in SAP / Shells?
If only one subject in the study, what would be the default statistics by using proc means
Have you involved in reviewing outputs? Have you involved in reviewing outputs?
What are the different ways that you follow while reviewing Outputs
What are the procedures that you have used while reporting the data?
How will you handle footnotes? What are the maximum footnotes that you can assign for a listing / table?
What is your approach of creating footnotes, if you have more than 10 footnotes for a listing / table?
Suppose if you have 200 pages of listing, how will you validate the same?

If we have 20 Columns for Listings and if we want to print some of the columns to the next page, how will do that?
SAS-technical
Difference between defining SAS macro variables via %let and call symput?
Dataset has two variables (Name and Val). Name variable values have to be stored as macro names and Val variable values
have to be stored as macro values using call symput.
What are the debugging options for macros? Explain them.
Difference between INTNX and INTCK functions. Their application?
How do we use SAS function inside a SAS macro?
How to read special characters in macro?
Explain SUBSTR right and left functions.
Differences between TRANSLATE and TRANSWRD functions, their syntax.
What happens when you run TRANSPOSE procedure without ID statement?
Explain the significance of compute statement?
How to remove a library?
How many ways to create macros. What are they?
What all functions you have used? Explain any three?
What is the difference between mean function and Proc Means?
What is the difference between index function and find function?
If I have a 100 variables in the dataset and I want to rename those in a single data step, how it is done
How to check whether the variable is presented in the dataset or not?
Difference between call Symput and Call Symputx?
Macro Quoting functions and why you have used it?
Difference between SQL joins and Merge statement, which you felt more useful and why?
How to pick first and last values from a variable using Proc SQL?
Difference between defining SAS macro variables via proc sql and call symput?
How does criterion option work in PROC COMPARE

OTHER
Scenario: when you have deliverables and timelines are stringent and you understand that you will not be able to submit in
time. How would you handle the situation?
Difference between safety and efficacy analysis. Specify some efficacy evaluations you have come across?
Endpoints of current therapeutic area?
Have you worked on oncology? If yes-What is time to event analysis? Explain the mock shell? Derivation of corresponding
variables.
What is RECIST criteria? Explain
What oncology domains you have worked on?
hat are ISS and ISE studies?
Have you worked on pooled studies? If yes, please explain
What are the challenges that you have faced while working on pooled studies?
What is define.xml & have you worked before on the same?
What are the requirements to create define.xml?
Have you ever created any study specific macros?
Have you ever worked on utility macros?
Explain for what are the cases that you have used utility macros
Do you ever get a chance for updating any utility macros? If so, what are updates that you have done
What are the different therapeutic areas you have worked?
What is the major difference between vaccines & drug related studies?
What are the challenges / differences you found between vaccines & drug related studies?
Have you ever worked on multiple studies at the same time? If yes situation when deliverables for 2 studies are close. How
will you handle the situation?
Have you been part of training the people?
What is the difference between IF and where?
2) What are all the procedures you have used while working on assignments? Why?
3) What all functions you have used? Explain any three?
4) What is the difference between mean function and Proc Means?
5) What is the use of IN operator?
6) What is the difference between index function and find function?
7) What is the use of first.varibale and last.variable? why you have used it?
8) Difference between SUM function and + operator?
9) How to make first letter of the string capital?
10) How to extract 200 characters from a string?
11) If I have a 100 variables in the dataset and I want to rename those in a single data step, how
you will do that?
12) How to check whether the variable is presented in the dataset or not?
13) Difference between call Symput and Call Symputx?
14) Have you Created any Macros? If Yes, have you created any study specific Macros or for own
purpose?
15) Ways to create macro variables?
16) How to debug errors in Macro?
17) Macro Quoting functions and why you have used it?
18) Explain any Macro you have created and why?
19) Difference between SQL joins and Merge statement, which you felt more useful and why?
20) How to pick first and last values from a variable using Proc SQL?
21) How to create Macro Variable using Proc SQL?
SDTM:
22) What is CDISC? Explain briefly why we need to follow CDISC in clinical domain?
23) What is SDTM, Classifications in SDTM?
24) Type of Core Variables?
25) What all domains have you worked?
26) What are General special purpose class? What all domains come under it?
27) What are events class? What is the topic variable? Name any two domains under this class?
28) What are findings domains? What is the topic variable? Name any two domains under this
class?
29) What is SUPP domain? What is it’s purpose?
30) If you have only Protocol, what are the SDTM domains you can able to develop?
31) What are TDM’s and how are they are developed?
32) What is Treatment Emergent Adverse Event? Derivation for TEAE?
33) If any event that is Severe before taking treatment and it’s Mild after the treatment, will
that be a TEAE?
34) What are Serious Adverse Events? Derivation for SAE’s?
35) What is Baseline? How do you derive it? Sample code to derive?
36) Derived Variables in DM?
37) Difference between planned and actual Treatments?
38) If the subject is “Screen Failure”, what will be the ARM and AMRCD values?
39) If the subject is Randomized and not taken any treatment, what will be the ARM and AMRCD
values?
40) Derivation of RFSTDTC?
41) Difference between RFSTDTC and RFXSTDTC?
42) What are the values for IDVAR and IDVARVAL in SUPPDM?
43) Which are the SDTM Domains you need to start with?
44) What are the key variables in SV, and derivation of SVSTDTC and SEENDTC?
45) If we have different dates for same visit, what you will do in that case?
46) Which is the most complicated Domain in SDTM, why?
47) Which variable indicates the extra records added into the finding Domains?
48) What are Unscheduled Visits and how to handle?
49) Study Day calculation?
50) Conversion of Original results to Standard?
51) Have you aware of OPEN CDISC Validator, what are the inputs to run the report?
52) What are acceptable issues in pinnacle21 report.
ADaM:
53) ADAM Classifications?
54) What are the Domains you have worked on?
55) What are the variables in ADSL.?
56) Different Population Flags in ADSL and their derivations.?
57) How to represent Treatment variables for Cross over study?
58) ADAE will comes under which classification of ADaM’s?
59) Explain about variables DTYPE, PARAMTYPE and BAETYPE.?
60) Derivation of ABLFL, CHG and PCHG.?
TL’s
61) Difference between Tables and Listings.?
62) What are the Tables have you worked on.?
63) Different AE tables you are worked on.?
64) How to calculate Header Counts.?
65) What are the procedures used for Categorical data.?
66) What are the procedures used for continuous data.?
67) How you have calculated %?
68) How many footnotes can be displayed using FOOTNOTE statement, if we have more than 10
Footnotes, how it will be printed in the report.?
69) How to calculate No of Events in AE reports? And how to will differ from No of Subjects.?
70) If a subject has 2 Events, what will be the count for No of Events and No of subjects.?
71) If SOC count is 5 and PT count is 6, have you seen such scenarios?
72) What are the reports you have worked for LB?
73) Have you worked on Change From Baseline Tables, what are they?
74) Have you worked on Shift Tables, concept for the shift tables?
75) If we have 20 Columns for Listings and if we want to print some of the columns to the next
page, how will do that?
76) How to print text before the Header Line?
77) What is population flag will be used for Efficacy analysis?
x

x
x

x
x
x
x

x
SDTM
Difference between study day and relative day
Difference between epoch vs element
Difference between SV vs TV
What is the use of SVUPDES variable in SV domain?
What is the purpose of populating VSLOC or LBLOC variables in SDTM datasets
What is your approach to create SV domain
Difference between SUPP and RELREC domains

ADaM
LOCF vs WOCF. In which variable do you populate these in ADaM
Have you ever worked on visit window? What is the approach for creating visit window?
How many data structures we have in ADaM IG 1.1 version?
How do you create last contact date for a subject?

TFL's
Can you please explain ISS and ISE. What type of challenges you faced while creating
ISS/ISE datasets?
What is Interim analysis? What are the advantages of Interim analyis
Have you ever worked on DSUR and PSUR? what is the purpose of DSUR & PSUR?
Can you please explain LAB shift table? Which variables do you consider from ADLB to
create LAB shift table
Difference between ITT vs FAS
How did you validate TFL's? Which validation procedure you use to validate
where do you use meddra and who dictionaries?
Have you ever worked on Graphs? Which procedures have you used for generating grpahs?
Have you heard about misrandomization? Can you please explain
Difference between SUPP and RELREC domains
SNO Question
1 Can you define best overall response?
2 DIfference between CR,PR and SD?
3 What are Target & Non-Target lesions?
To confirm CR,PR status by repeat assessments how many weeks we should consider after after the
4 criteria for response are first met
5 What do you mean by censoring of a varaible?
6 To find survival estimates Which variables do you pass in Time statement in PROC LIFETEST
7 What is the use PHREG procedure?
8 Difference between Overall Survival vs Progression-free Survival
9 What is CTCAE? Which version of CTCAE currently you are using
Have you ever worked on Oncology specific SDTM domains? Can you please explain those domains
10 in detail