Clinical SAS is the best career option as it provides tremendous job opportunities for freshers and experienced candidates. Top companies around the world are employing certified and skilled Clinical SAS professionals to work as Clinical SAS developers, Clinical SAS programmers, Senior SAS Administrators, and Clinical SAS Architect. We have prepared frequently asked interview questions and answers in Clinical SAS for the students to ace the interview of big companies. Learn the best Clinical SAS Certification Training in Chennai at Softlogic to obtain suitable positions.
1. What is Clinical SAS meant exactly?
SAS (Statistical Analysis System) is applied in clinical trial data analysis for pharmaceutical, biotechnology, and clinical research organization. It helps clinical research professionals to obtain great speed and accuracy while conducting clinical trials.
2. What are the phases in clinical trials?
There are four major phases in clinical trials as follows:
Phase 1: Testing a new treatment or drug to a small group of people (20 – 80) for evaluating the safety
Phase 2: Experiment with drug or treatment for a large group of people (100 – 300) to validate the drug is effective or not.
Phase 3: Experiment on a treatment or drug to a large group of people (1000 – 3000) to check the actual effectiveness along with monitoring of side effects and compare with previous drugs.
Phase 4: Submit the study results for post-marketing that includes risk and benefits of the proposed drug or treatment.
3. Define Validation procedure.
Validation Procedure is the process used to verify the output of the SAS program that is generated by the programmer. If the output generated by the process validator is the same as the output generated by the SAS programmer then the program is valid.
4. What is TLG and how it used in clinical trials?
TLG is the acronym of (Table, Listing, and Graph) that helps in performing the Validation Procedure to check the output of the SAS program.
5. How to validate the listing of clinical trial that contains 400 pages?
As the validation of listing that has 400 pages is impossible through a manual process, it is converted to listing in data sets using PROC REPORT for comparing through PROC COMPARE.
6. How to generate Tables, Listing, and Graphs?
PROC REPORT is the procedure used to generate the listings, PROC FREQ, PROC MEANS, and PROC TRANSPOSE are the procedures to generate tables, and PROC GPLOT is the procedure for generating Graphs in Clinical SAS.
7. How many tables can be created in a day?
It depends on the complication of tables. If the tables are the same type, we can generate up to 3 tables in a day.
8. What are the documents to be submitted to FDA?
ISS and ISE documents are to be submitted to FDA.
9. How can ISS and ISE documents submitted to FDA and who can submit them?
The submission of documents in FDA is done through e-submission using define.pdf or define.xml formats. Statistician or Project Manager will submit the documents to FDA.
10. Define Clin-trial database and oracle clinical.
Clintrial is the popular and leading Clinical Data Management System (CDMS) and Oracle Clinical (OC) is a database management system framed by Oracle to offer data management and data entry along with data validation functionalities to the clinical trials process.
11. Define SDTM
SDTM is an acronym of Study Data Tabulation Model that has been built to standardize the submitted document to the FDA.
12. Describe CRT
CRT is Case Report Tabulation that is to be submitted by a pharmaceutical company an NDA to FDA.
13. Define Annotated CRF
Annotated CRFs (Case Report Form) are the variable names next to spaces to offer to the investigator. These are act as a link between the raw data and the queries to CRF. It is a useful tool for statisticians and programmers.
14. What are the contents of lab data?
The lab data set consists of SUBJID, week number, standard units, category of lab test, and lab normal and high range of values.
15. What is the goal of the lab data set?
The purpose of the lab data set is to retrieve the difference in the values of key variables after the drug administration.
16. Define verification
The work of the verification is to ensure the quality of SAS programs has created the final tables and the accuracy of the final tables.
17. Describe program validation
It is the validation same as macro validation that the SAS programmer has to validate the programs as per the rule of SOP to determine the result of the program such as creating a validation document monitoring and status of pass or fail.
18. What is the main responsibility of a Clinical SAS Programmer?
Clinical SAS Programmer has to develop programming for report formats such as ISS and ISE Shell that are required by regulatory authorities and update them whenever it is needed.
19. What is the Clinical Study Team?
Clinical Study Team provides information on safety and efficacy findings as per the requirements along with periodic reporting.
20. List some of the variable names in the SAS domain
There are some variables widely used in programs such as Demog, Adverse Events, Vitals, ECG, Labs, and physical exam.
21. What are the things to be given in Adverse Events?
Adverse Events is applicable for Protocol no, Patient ID, Preferred term, Investigator no, investigator term, severity, seriousness, seriousness type, visit number, start time, stop time, and study drug.
22. What are things to be given in Demog?
Demog will be included Patient ID, Age, Sex, Usubjid, race, screening height, screening weight, BMI, and so on.
23. What are the things to be given in Vitals?
Vital variables include subject number, procedure time, study date, sitting blood pressure, visit number, sitting cardiac rate, change from baseline, Abnormal, dose of treatment, BMI, Diastolic blood pressure, and systolic blood pressure.
24. What are the things to be given in the PhysicalExam variable?
PhysicalExam contains subject no, exam date, exam time, reason for exam, visit number, body system, findings, abnormalities, change from baseline, and comments.
25. What are the things to be included in the ECG variable?
Study data, study time, subject no, visit no, PR interval, QRS duration, QT interval, Ventricular rate, abnormal, QTc interval, and change from baseline are included in the ECG variable.
26. What are the things that can be added to the lab variable?
Subject no, study day, lab parameter, lab units, ULN (Upper Limit of Normal), LLN (Lower Limit of Normal), change from baseline, visit number, medical condition, date of diagnosis, past condition, years of onset, or occurrences, and current condition are comes under Labs variable.
27. Explain Hard Coding
Hard Coding is required when the report is to be produced urgently by a programmer. Hard Coding is better to avoid as it overrides the database controls in clinical data management.
28. How to write a test plan?
Functional specifications to be considered before writing a test plan as it depends on requirements with the understanding of functional needs.
29. Define PROC CDISC
It is one of the SAS procedures that is available as a hotfix for the SAS 8.2 version and comes with the SAS 9.1.3 version. It allows the programmers to import or export XML files.
30. What are the macro libraries?
Macro libraries have all the macros needed for developing TLGs of clinical trial and these are important to control and manage with the help of %INLUDE statement. It is automatically called whenever required.
31. What is the usage of ODS?
ODS (Output Delivery System) is used to bring the output from tables, listings, and graphs to look accurate. It generates the outputs in HTML, pdf, and RTF formats.
32. How to get survival estimates with any other procedures?
PROC LIFEREG and PROC PHREG are used with PROC LIFE TEST to get survival estimates.
33. What can be done with Proc Life Test?
PROC LIFETEST is used to retrieve Kaplan-Meier and life table survival estimates that compare with different groups.
34. What is the advantage of using SAS in clinical data management?
SAS required less hardware usage and fewer human resources and it is good for clinical trial data management.
35. When PROC SQL is to be used?
PROC SQL supports all functions in the DATA step for generating data as well as data manipulation. It will be compared with the result retrieved with data step and PROC SQL needs less code and less execution time.
36. How to create transport files?
PROC COPY and data step are used to create SAS XPort transport files for FDA submissions. It is used to create a simple patient listing that had all information about a particular patient and it includes sex, race, and age, and so on.
37. What is a project status meeting?
Project Status Meeting is the planetary meeting of all project managers for discussing the present status of a project and new ideas along with options that improve the way it is being performed.
38. What are the popular stat procedures?
ANOVA, CATMAD, GLM, FREQ, LIFETEST, LIFEREG, LOGISTIC, REG, TTEST, UNIVARIATE, SUMMARY, and MEANS are popular stat procedures.
39. What is nested macro?
The execution of macro within a macro is called nested macro and it allows identifying the keyword %macro that is end with %mend. Nested macros obtained by symget and call symput macros.
40. What are the general guidelines to implement SDTM variables?
SDTM domain consists of variables with five roles such as Identifier, Topic, Timing, Qualifier, and Trial Design Domain.