Question 1. Describe The Phases Of Clinical Trials?
These are the following 4 levels of the scientific trials:
Phase 1: Test a brand new drug or treatment to a small organization of human beings (20-80) to evaluate its protection.
Phase 2: The experimental drug or remedy is given to a massive group of humans (one hundred-300) to see that the drug is effective or not for that treatment.
Phase three: The experimental drug or treatment is given to a large organization of people (one thousand-3000) to look its effectiveness, display facet results and compare it to generally used treatments.
Phase 4: The 4 section have a look at consists of the publish advertising research together with the drug’s threat, benefits and many others.
Question 2. Describe The Validation Procedure? How Would You Perform The Validation For Tlg As Well As Analysis Data Set?
Validation manner is used to check the output of the SAS software generated through the source programmer. In this process validator write the program and generate the output. If this output is same because the output generated with the aid of the SAS programmer’s output then the program is taken into consideration to be legitimate. We can perform this validation for TLG by using checking the output manually and for analysis statistics set it can be finished the usage of PROC COMPARE.
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Question three. How Would You Perform The Validation For The Listing, Which Has 400 Pages?
It isn't always viable to carry out the validation for the listing having 400 pages manually. To do this, we convert the listing in statistics sets via using PROC REPORT and then after that we are able to compare it by using PROC COMPARE.
Question 4. Can You Use Proc Compare To Validate Listings? Why?
Yes, we will use PROC COMPARE to validate the listing due to the fact if there are numerous entries (pages) inside the listings then it isn't possible to test them manually. So in this circumstance we use PROC COMPARE to validate the listings.
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Question five. How Would You Generate Tables, Listings And Graphs?
We can generate the listings via the usage of the PROC REPORT. Similarly we can create the tables by means of using PROC FREQ, PROC MEANS, and PROC TRANSPOSE and PROC REPORT. We might generate graph, the use of proc Gplot and so forth.
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Question 6. How Many Tables Can You Create In A Day?
Actually it depends on the complexity of the tables if there are same kind of tables then, we are able to create 1-2-three tables in an afternoon.
Question 7. How Would You Submit The Docs To Fda? Who Will Submit The Docs?
We can put up the docs to FDA through e-submission. Docs can be submitted to FDA the usage of
Define.Pdf or define.Xml formats. In this document we have the documentation about macros and application and E-information additionally. Statistician or challenge manager will submit this doc to FDA.
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Question eight. What Are The Docs Do You Submit To Fda?
We post ISS and ISE files to FDA.
Question nine. Tell Me About Your Project Group? To Whom You Would Report/touch?
My assignment group inclusive of six participants, a mission manager, two statisticians, lead programmer and two programmers.
I normally file to the lead programmer. If I have any trouble concerning the programming I might contact the lead programmer.
If I even have any doubt in values of variables in raw dataset I could contact the statistician. For example the dataset related to the menopause signs and symptoms in ladies, if the variable intercourse having the values like F, M. I could recall it as incorrect; in that kind of conditions I would touch the statistician.
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Question 10. Explain Sas Documentation.?
SAS documentation includes programmer header, feedback, titles, footnotes and many others. Whatever we kind inside the software for making the program easily readable, without difficulty understandable are in known as as SAS documentation.
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Question eleven. How Would You Know Whether The Program Has Been Modified Or Not?
I would recognize the program has been modified or not via seeing the change history in the software header.
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Question 12. Project Status Meeting?
It is a planetary meeting of all of the venture managers to speak about approximately the present Status of the undertaking in hand and talk new thoughts and options in improving the Way it's miles currently being performed.
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Question thirteen. Describe Clin-trial Data Base And Oracle Clinical?
Clintrial, the marketplace’s leading Clinical Data Management System (CDMS).Oracle Clinical or OC is a database control system designed via Oracle to offer records control, statistics entry and statistics validation functionalities to Clinical Trials method.
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Question 14. Describe Sdtm?
CDISC’s Study Data Tabulation Model (SDTM) has been evolved to standardize what's submitted to the FDA.
Question 15. What Is Crt?
Case Report Tabulation, Whenever a pharmaceutical organization is submitting an NDA, conpany has to send the CRT’s to the FDA.
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Question 16. What Is Annotated Crf?
Annotated CRF is a CRF(Case file form) wherein variable names are written subsequent the areas provided to the investigator. Annotated CRF serves as a hyperlink between the raw data and the questions on the CRF. It is a precious device for the programmers and statisticians.
Question 17. What Do You Know About 21crf Part 11?
Title 21 CFR Part 11 of the Code of Federal Regulations offers with the FDA recommendations on digital statistics and electronic signatures in the United States. Part 11, as it's miles typically known as, defines the criteria beneath which digital records and electronic signatures are taken into consideration to be truthful, dependable and equivalent to paper information.
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Question 18. What Are The Contents Of Ae Dataset? What Is Its Purpose? What Are The Variables In Adverse Event Datasets?
The damaging occasion facts set includes the SUBJID, frame machine of the event, the favored term for the occasion, occasion severity. The cause of the AE dataset is to offer a summary of the damaging occasion for all of the sufferers within the treatment arms to useful resource in the inferential safety evaluation of the drug.
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Question 19. What Are The Contents Of Lab Data? What Is The Purpose Of Data Set?
The lab facts set includes the SUBJID, week variety, and class of lab take a look at, standard gadgets, low normal and high variety of the values. The purpose of the lab facts set is to reap the difference within the values of key variables after the administration of drug.
Question 20. How Did You Do Data Cleaning? How Do You Change The Values In The Data On Your Own?
I used proc freq and proc univariate to find the discrepancies inside the records, which I stated to my manager.
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Question 21. Have You Created Crt’s, If You Have, Tell Me What Have You Done In That?
Yes I even have created affected person profile tabulations as the request of my supervisor and and the statistician. I actually have used PROC CONTENTS and PROC SQL to create simple affected person listing which had all statistics of a specific affected person which include age, intercourse, race and so on.
Question 22. Have You Created Transport Files?
Yes, I have created SAS Xport transport files the usage of Proc Copy and facts step for the FDA submissions. These are model five files. We use the libname engine and the Proc Copy technique, One dataset in each xport transport layout file. For model 5: labels not than forty bytes, variable names eight bytes, man or woman variables width to two hundred bytes. If we violate these constraints your replica method may also terminate with constraints, because SAS xport format is in compliance with SAS 5 datasets.
Libname sdtm “c:sdtm_data”;Libname dm xport “c:dm.Xpt”; Proc reproduction; In = sdtm; Out = dm; Select dm; Run;
Question 23. Have You Ever Done Any Edit Check Programs In Your Project, If You Have, Tell Me What Do You Know About Edit Check Programs?
Yes I even have done edit test packages .Edit take a look at packages – Data validation.
1.Data Validation – proc way, proc univariate, proc freq.Data Cleaning – finding errors.
2.Checking for invalid man or woman values.Proc freq statistics = patients;Tables gender dx ae / nocum nopercent;Run;Which gives frequency counts of precise character values.
Three. Proc print with in which statement to list invalid information values.[systolic blood pressure – 80 to 100][diastolic blood pressure – 60 to 120]
4. Proc approach, univariate and tabulate to look for outliers.Proc manner – min, max, n and suggest.Proc univariate – 5 highest and lowest values[ stem leaf plots and box plots]
5. PROC FORMAT – range checking
6. Data Analysis – set, merge, update, preserve, drop in statistics step.
7. Create datasets – PROC IMPORT and data step from flat documents.
8. Extract records – LIBNAME.
Nine. SAS/STAT – PROC ANOVA, PROC REG.
10. Duplicate Data – PROC SORT Nodupkey or NoduplicateNodupkey – best tests for duplicates in BYNoduplicate – tests entire statement (matches all variables)For getting duplicate observations first kind BY nodupkey and merge it again to the authentic dataset and keep simplest data in authentic and taken care of.
11.For creating analysis datasets from the uncooked information sets I used the PROC FORMAT, and rename and length statements to make changes and subsequently make a analysis facts set.
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Question 24. What Is Verification?
The reason of the verification is to ensure the accuracy of the very last tables and the satisfactory of SAS packages that generated the very last tables. According to the commands SOP and the SAP I selected the subset of the final precis tables for verification.
Example: Adverse occasion desk, baseline and demographic traits desk.The verification outcomes had been established in opposition to with the authentic very last tables and all discrepancies if existed had been documented.
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Question 25. What Is Program Validation?
Its same as macro validation except here we should validate the packages i.E in step with the SOP I needed to first decide what the program is meant to do, see if they work as they're alleged to paintings and create a validation report bringing up if this system works well and set the reputation as skip or fail.Pass the input parameters to this system and take a look at the log for mistakes.
Question 26. What Do You L Know About Iss And Ise, Have You Ever Produced These Reports?
ISS (Integrated precis of safety):Integrates protection records from all resources (animal, medical pharmacology, controlled and out of control research, epidemiologic facts). “ISS is, in component, without a doubt a summation of facts from individual studies and, in element, a brand new evaluation that goes beyond what can be done with person research.”ISE (Integrated Summary of efficacy)ISS & ISE are essential additives of the safety and effectiveness submission and expected to be submitted within the application according with regulation. FDA’s steerage Format and Content of Clinical and Statistical Sections of Application offers advice on a way to construct these summaries. Note that, in spite of the call, these are included analyses of all applicable data, no longer summaries.
Question 27. Roles And Responsibilities Programmer?
Develop programming for report codecs (ISS & ISE shell) required by the regulatory authorities.Update ISS/ISE shell, when required.
Clinical Study Team: Provide records on protection and efficacy findings, while required.Provide updates on protection and efficacy findings for periodic reporting. Study Statistician Draft ISS and ISE shell.Update shell, while appropriate.Analyze and file statistics in authorised format, to meet periodic reporting requirements.
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Question 28. Explain Types Of Clinical Trials Study You Come Across?
Single Blind Study When the sufferers are not aware of which treatment they obtain. Double Blind Study When the patients and the investigator are ignorant of the treatment organization assigned. Triple Blind Study Triple blind examine is while sufferers, investigator, and the undertaking crew are blind to the remedies administered.
Question 29. Can You List The Variables In All The Domains?
Demog: Usubjid, Patient Id, Age, Sex, Race, Screening Weight, Screening Height, BMI and so on
Adverse Events: Protocol no, Investigator no, Patient Id, Preferred Term, Investigator Term, (Abdominal dis, Freq urination, headache, dizziness, hand-meals syndrome, rash, Leukopenia, Neutropenia) Severity, Seriousness (y/n), Seriousness Type (demise, lifestyles threatening, completely disabling), Visit wide variety, Start time, Stop time, Related to examine drug?
Vitals: Subject wide variety, Study date, Procedure time, Sitting blood pressure, Sitting Cardiac Rate, Visit quantity, Change from baseline, Dose of remedy at time of vital signal, Abnormal (sure/no), BMI, Systolic blood stress, Diastolic blood strain.
ECG: Subject no, Study Date, Study Time, Visit no, PR interval (msec), QRS period (msec), QT c programming language (msec), QTc c programming language (msec), Ventricular Rate (bpm), Change from baseline, Abnormal.
Labs: Subject no, Study day, Lab parameter (Lparm), lab units, ULN (higher limit of ordinary), LLN (decrease restrict of regular), visit range, alternate from baseline, Greater than ULN (sure/no), lab related critical destructive occasion (sure/no).Medical History: Medical Condition, Date of Diagnosis (yes/no), Years of onset or incidence, Past condition (sure/no), Current condition (sure/no).
PhysicalExam: Subject no, Exam date, Exam time, Visit variety, Reason for examination, Body system, Abnormal (yes/no), Findings, Change from baseline (development, worsening, no change), Comments.
Question 30. Give Me The Example Of Edit Ckecks You Made In Your Programs?
Examples of Edit Checks Demog: Weight is outside anticipated rangeBody mass index is below predicted ( check weight and height) Age isn't within predicted range. DOB is extra than the Visit date or no longer.. Gender cost is a legitimate one or invalid. And many others Adverse Event Stop is before the begin or go to Start is earlier than birthdate Study medication discontinued because of adverse occasion but completion indicated (COMPLETE =1)
Labs Result is within the regular variety but peculiar isn't always blank or ‘N’Result is outside the regular range however peculiar is blank
Vitals Diastolic BP > Systolic BP
Medical History Visit date prior to Screen datePhysicalPhysical exam is ordinary but remark covered
Question 31. What Do You Feel About Hard Coding?
Programmers sometime hardcode after they want to produce file in pressing. But it is usually better to avoid hardcoding, because it overrides the database controls in clinical statistics management. Data frequently change in a tribulation over the years, and the hardcode that is written nowadays won't be valid in the future.Unfortunately, a hardcode can be forgotten and left inside the SAS software, and which can cause an incorrect database trade.
Question 32. How Do You Write A Test Plan?
Before writing “Test plan” you need to investigate on “Functional specs”. Functional specs itself relies upon on “Requirements”, so one must have clear knowledge of requirements and purposeful specs to jot down a check plan.
Question 33. What Is The Difference Between Verification And Validation?
Although the verification and validation are near in that means, “verification” has greater of a sense of testing the truth or accuracy of a declaration by examining proof or carrying out experiments, at the same time as “validate” has extra of a feel of declaring a assertion to be genuine and staining it with an illustration of respectable sanction.
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Question 34. What Is Proc Cdisc?
It is new SAS system that is to be had as a hotfix for SAS 8.2 version and is derived as a component withSAS 9.1.3 version. PROC CDISC is a manner that permits us to import (and export XML files which might be compliant with the CDISC ODM model 1.2 schema. For more info refer SAS programming inside the Pharmaceutical Industry textual content e-book.
Question 35. What Is Locf?
Pharmaceutical companies behavior longitudinalstudies on human subjects that often span several months. It is unrealistic to count on sufferers to hold each scheduled visit over this sort of lengthy period of time.Despite every attempt, patient facts are not amassed for a while factors.
Eventually, these turn out to be lacking values in a SAS records set later. For reporting purposes,the most current previously available cost is substituted for every missing go to. This is referred to as the Last Observation Carried Forward (LOCF).LOCF doesn’t suggest final SAS dataset remark carried ahead.
It manner ultimate non-lacking price carried forward. It is the values of individual measures that are the “observations” in this example. And if you have a couple of variables containing those values then they will be carried ahead independently.
Question 36. What Are Macro Libraries?
Macro libraries are the libraries, which stores all the macros required for growing TLG’s of the clinical trial. These are very are necessary in controlling and coping with the macros. With the assist of a %INCLUDE announcement; the stored macros inside the macro library may be mechanically referred to as.
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Question 37. Why Do You Use Ods?
ODS (Output Delivery System) usually used to make the output from the Tables, Listings and graphs seems pretty. ODS creates the outputs in html, pdf and rtf codecs.
Question 38. What Are The Graphs You Created?
Survival estimate graphs.
Question 39. How To Generate Statistics Using Proc Sql?
Yes, we can generate the information like N, Mean, Median, Max, Min, STD & SUM the usage of PROC SQL. But SQL technique can not calculate all the above facts by way of default, as it is the case with PROC MEANS.
Question forty. When To Use Proc Sql?
The SQL manner supports nearly all of the capabilities available within the DATA step for the creation of statistics in addition to the manipulation of the data. When we compare the equal result, acquired from SQL and with the Data step, PROC SQL calls for much less code and, extra importantly it requires much less time to execute the code.
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Question forty one. Which Procedure Is Used To Create Reports?
Proc Report, proc Tabulate and Data _null_.
Question forty two. What Is The Difference Between Stratum And By Statement In Proc Lifetest?
We specify a BY declaration with PROC LIFETEST to achieve separate analyses on observations in groups described through the BY variables.
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Question forty three. What Are The Advantages Of Using Sas In Clinical Data Management?
Less hardware is required and less personnel are required.
Question forty four. Describe The Validation Procedure?
Validation technique is used to check the output of the SAS program, generated by using the supply programmer. In this process validator write this system and generate the output
Question forty five. Can You Get Some Value Of A Data Step Variable To Be Used In Any Other Program You Do Later In The Same Sas Session? How Do You Do That?
Use a macro… with a %PUT declaration.
Question forty six. What Would You Do If You Have To Access Previous Records Values In Current Record?
Using ampersand signal…. &var.
Question 47. What Is A P Value? Why Should U Calculate That? What Are The Procedures You Can Use For That?
If the p-fee have been more than 0.05, you will say that the group of impartial variables does now not display a statistically considerable courting with the structured variable, or that the group of impartial variables does now not reliably predict the based variable. Note that this is an universal significance take a look at assessing whether the group of impartial variables, while used collectively reliably predicts the based variable, and does now not cope with the capacity of any of the specific unbiased variables to are expecting the structured variable. Using the PROC FREQ, PROC ANOVA, PROC GLM and PROC TTEST we cal calculate the p-price.
Question 48. What Do You Usually Do With Proc Life Test?
PROC LIFETEST is used to achieve Kaplan-Meier and life table survival estimates (and plots). Using a strata declaration in Proc Lifetest, which evaluate survival estimates for one of a kind agencies.
Question 49. Can You Get Survival Estimates With Any Other Procedures?
PROC LIFEREG and PROC PHREG also can be used to get the survival estimates along with PROC LIFETEST.
Question 50. How Did You Create Analyzed Data Sets?
Analysis datasets are nothing but the datasets which are used for the statistical evaluation of the information. Analysis datasets contains the raw records and the variables derived from the uncooked facts. Variables, that are derived for the uncooked statistics, are used to provide the TLG’s of the medical take a look at.
The protection in addition to efficacy endpoints (parameters) dictate the type of the datasets are required via the clinical study for generating the statistical reviews of the TLG’s. Sometimes the evaluation datasets could have the variables now not always required to generate the statistical reports however every now and then they'll required to generate the ad-hoc reports.