Get 50+ SAS CDM Interview Questions and Answers

Last updated on 14th Nov 2021, Blog, Interview Questions

If you’re looking for SAS CDM Interview Questions for Experienced or Freshers, you are at the right place. There are a lot of opportunities from many reputed companies in the world. According to research, SAS CDM has a market share. So, You still have the opportunity to move ahead in your career as a SAS Programmer Analyst. ACTE offers Advanced SAS Clinical Data Management Interview Questions that helps you in cracking your interview & acquire your dream career as Clinical SAS Programmer.

1.What are the phases of clinical trials?

Ans:

The following are some of the phases contained in the clinical trials of SAS: –

• In the first phase, it can test the new treatment or drug that belongs to a small group of people.
• The second phase in the clinical trials can be stated as the experimental treatment or drug that completely belongs to a large group of people.
• The phase 3 clinical trials are mainly used to monitor the side effects by comparing them to the commonly used treatments.
• Finally, phase 4 can be used to study all the marketing studios that include the benefits and drug’s risk.

2.What is the validation procedure and how could you perform the validation using the data set?

Ans:

The validation process in the SAS program mainly verifies the specific output of the program, which is generated by the source programmer. In this programming process, the validator will write the program in order to generate the output which is considered to be valid. You can also activate the validation process by checking the output manually that analyzes the data set using the PROC COMPARE.

3.How to perform the validation for listing if it is 400 pages?

Ans:

However, it is impossible to validate the long-term listing which contains 400 pages, but we can translate the data into the respective data set with the help of the PROC report, and later we can use the PROC COMPARE to compare the data.

4.How and why to use the PROC COMPARE to validate the listings?

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Yeah for sure, we can definitely make use of the PROC COMPARE in order to validate the data listing that is entered into the listings manually with the help of this condition.

5.How to generate listings, graphs, and tables in SAS CDM?

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With the help of PROC REPORT, we can easily generate the listings, PROC FREQ, PROC TRANSPOSE, And PROC mean to create the tables, whereas to create the graph we can use the PROC Gplot option.

6.How many tables can you create in a single day by using the CDM in SAS?

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Basically, the creation of tables is based on complexity. For example, If the fore creating tables belong to the same type, then you can create 1-3 tables per day.

7.Explain the Data Sets that are known by you?

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The following are some of the data sets which we are generally used for the data validation in CDM like Laboratory, analysis, adverse events, and demographics.

8.What is meant by PROCS?

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The PROCS in the CDM is mainly used to generate the report list according to the display variables that are mentioned in the data validation process.

9.How to submit the documents to FDA and who is responsible to do that?

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In order to submit the documents to the FDA, we need to use the .pdf or can define the.XML formats. In this process, there is a chance to know more about the macros as well as the programs and records too.

10.What is the SAS documentation?

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Generally, the SAS documentation will include all the comments, titles, programmer header, and footnotes in order to read and understand the program easily.

11.Explain Oracle clinical and Clin-trial database?

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The oracle clinical in the SAS is defined as the data management system which is specifically designed by the team of data management functionalities that can process the entire trials.

12.What is SDTM?

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The SDTM in the SAS CDM is stated as the study Data tabulation model which is generally developed to perfection the submitted FDA.

13.Explain CRT?

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CRT means Case Report Tabulation, which is a document that needs to submit an NDA for the company CRTs to the respective FDA.

14.Explain the contents that contain in the AE dataset and what is their purpose?

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The adverse events that contain the data set are used to summarise the events according to the patient’s lists, treatments that aid in the safety analysis of the specified drug.

15.Explain the contents included in the lab data?

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Basically, the lab data set will contain the category of a lab test, standard units, week number, and SUBJID, which is mainly used to retrieve the main difference between the key variables contained in the drug administration.

16.How to clean and change the values in the data on your own?

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It is recommended to use the PROC UNIVARIATE and the PROC FREQ that are found in the data.

17.How to create the CRTs?

Ans:

In order to create the profiles of the patients, we definitely need to use the PROC SQL and PROC CONTENTS in order to create new simple patients listings, which may contain the sex, age, and race of the patients.

18.Explain the main difference between validation and verification?

Ans:

However, the validation and verification meaning will sound the same, but the verification process will have a more sense of testing that results from the accurate reports by conducting the experiments. Whereas the validation will also make it more meaningful by declaring the particular statement whether it is true or false.

19.Explain the SAS features and how do you use them for data validation and trapping?

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In order to validate and trap the date the following are some of the conditions that we have to use for it like Debug option and put statement.

20.Explain the PROC CDISC in SAS CDM.

Ans:

The PROC CDISC in the SAS CDM is one of the new procedures, which is currently available in the hotfix with the latest version. Basically, it is described as the process which may allow the users to import the data from the latest versions.

21.Being A Cd Manager, What Is Your Contribution Going To Be, To My Company?

Ans:

As a CD Manager, I can assure you of accurate, complete,consistent data for reporting, to the regulatory bodies. I also communicate & coordinate with the Project Manager, Statistician, CRA, DB Manager at the clinical sites as needed to ensure the accuracy and completeness of the CT data.

22.Who Is The Father Of Clinical Trials?

Ans:

James Lind

23.In Health Care, Can You Tell Me The Synonyms Of Ct?

Ans:

Clinical Research, Clinical Study, Medical Research.

24.Define Unapproved Therapeutic Goods?

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The Drugs which did not undergo Clinical Trial are called Unapproved Therapeutic Goods.

25.What Is Ind?

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During the trial, the agent being tested is called an IND(Investigational New Drug).

26.Describe The Importance Of Inclusion And Exclusion Criteria?

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Inclusion & exclusion criteria are important in that the subjects are either included in or excluded from a trial based on the inclusion and exclusion criteria.

27.What Is Meant By Masking Or Blinding?

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Masking or blinding is the process of hiding the details weather the research subject is receiving the Investigational product or a placebo or the current standard treatment. –

• Single Blinding: The subject doesn’t know about the treatment.
• Double Blinding: Both the researcher and the patient do not know about the treatment.

28.Emphasize The Importance Of Masking/blinding?

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Masking/ Blinding is necessary because it eliminates any bias in the treatment process being investigated.

29.What Is Placebo?

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A Placebo is an inactive pill, powder, liquid which contains no active agent. The use of a Placebo helps the researcher to isolate the effect of the study treatment.

30.What Is A Patient File? What Information Is Available In It?

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A Patient File (PF) contains the demographic data, Medical and treatment data about a patient or subject. It can contain paper records or can be a mixture of both paper and computer records.

31.What Are Pre Clinical Studies?

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Pre clinical studies are the animal studies that support Phase I safety and tolerance studies. They must comply with the GLP guidelines.

32.Describe The Scientific Names For All 4 Phases Of Trials?

Ans:

• Phase I : Human Pharmacology Trials.
• Phase II : Therapeutic exploratory trials.
• Phase III : Therapeutic Confirmatory Trials.
• Phase IV : Post marketing Surveillance Trials.

33.Distinguish Between Double Blind And Double Dummy?

Ans:

Double blind is where both the subject and the researcher do not know which of the treatment the subject is receiving i.e. whether control or the study treatment. In Double dummy, every subject is given both the control and the investigational treatment, for alternating periods.

34.Other Name For Qol (quality Of Life) Trial?

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Supportive Care Trial.

35.What Are Orphan Trials?

Ans:

Orphan trials aimed at testing drugs designed to treat diseases affecting less than 200,000 people. Tested only on a small number of participants, Who are so sick that the effect of treatment, if the drug really works, is immediately apparent.

36.What Are Pk Parameters?

Ans:

Pharmacokinetic parameters determine the characteristics of thedrug’s Absorption, Distribution, Metabolism and Excretion (ADME).

37.What Is Adme?

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Absorption, Distribution Metabolism and Excretion.

38.What Is Bioavailability?

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It is the fraction of administered dose of unchanged drug that reaches the systemic circulation.

39.What Is Bioequivalence?

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Used to assess the expected in-vivo biological equivalence of two proprietary preparations of drug. If two drugs are said to be bio equivalent, then they are expected to be for all intent and purpose, same.

40.Is It True That Phase I Trials Include Healthy Volunteers?

Ans:

Yes. But exception is made for the terminally ill patients who have no alternative therapy available.

41.What Is The Range Of Participants In Each Of The Four Phases Of Clinical Trials?

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• Phase I – 20 to 80.
• Phase II – 200 – 300.
• Phase III – 300 to 3000.
• Phase IV – Thousands of patients who are being treated.

42.What Is Efficacy?

Ans:

The measure of the maximum strength of the drug.

43. What Is Nce?

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New Chemical Entity.

44.How Can One Tell The Significance Or Power Of A Trial?

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By the size of the trial.

45.Describe The Incidents That Led To The Formation Of Ethical Principles In Clinical Trials?

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The three main incidents are the Thalidomide disaster, Tuskegee syphilis study and the Nuremberg war prisoner’s incidents.

46.What Does Nuremberg Code State?

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Nuremberg code (1948) states that the voluntary consent of the human subject is absolutely essential.

47.Who Are The Observers Of Ich?

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• The World Health Organization (WHO).
• The European Free Trade Area (EFTA), represented at ICH by Switzerland.
• Canada, represented at ICH by Health Canada.

48.Who Are The Participants Of Pharmacovigilance?

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• Patients as the users of medicines.
• Doctors, pharmacists, nurses and all other healthcare professionals working with medicines regulatory authorities EMEA and those in the member states responsible for monitoring the safety of medicines.
• Pharmaceutical companies and companies importing or distributing medicines.

49.What Is The Need Of Pharmacovigilance?

Ans:

• Illegal sale of medicines and drugs of abuse over the internet.
• Increased self medication practices.
• Widespread manufacture and sale of counterfeit and substandard medicines Increased use of traditional medications outside the confines of traditional culture of use.
• Increased use of medications of different systems with potential for drug interactions.

50.Describe The Attributes Of Ae?

Ans:

• Unrelated: The AE is clearly not related to the intervention.
• Unlikely: The AE is doubtfully related to the intervention.
• Possible: The AE is may be related to the intervention.
• Probable: The AE is likely related to the intervention.
• Definite: The AE is clearly related to the intervention.

51.Mention the Role Of Principal Investigator (pi)?

Ans:

The Principal Investigator has the overall responsibility of the design, conduct, analysis and reporting of Clinical Trial He has the overall responsibility for the coordination and the day-to-day management of the trial.

52.What Is Ctms?

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A CTMS describes the responsibilities of those involved in running the trial on a day-to-day basis.

53.What Is Cdms?

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CDMS is the tool used to ensure that the data gathered in the course of the study is: –

• Accurate.
• Complete.
• Logical.
• Consistent.
• The trial data collected at the investigator site is stored in a CDMS.

54.What Is Informed Consent?

Ans:

Informed consent is the voluntary consent obtained from the research subject to participate in the research, after explaining to the person of all the risks and benefits involved in the research.

55.What Randomization is required in a trial to isolate the drug effect.

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Randomization is required in a trial to isolate the drug effect.

56.What Is Crf And What Is It’s Importance?

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CRF stands for Case Report/Record Form. CRF is perhaps, the most important document after the protocol since all the clinical trial data is collected through the CRF.

57.What Is Data?

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Data means Information (facts/figures) which give an accounting of the study.

58.What Is Source Document?

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Source document means the first recording about the trial subject like original lab reports, pathology reports, surgical reports, medical records, letters from referring physicians, participant diary etc.

59.What Is Common Data Elements (cde)?

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Common Data Elements mean the standardized, unique terms and phrases that delineate discreet pieces of information used to collect data on a clinical trial.

60.What Are The Best Solutions For Clinical Data Management?

Ans:

• Data Analytics: AS 9 platform.
• EDC: Oracle clinical, phase forward, medidata solution etc.
• Document management Services:Documentum, Opentext, adobe solutions etc.

61.Define Digitization?

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Digitization is the process of converting the data into computer readable format.

62.What Is Db Closure?

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When a database is closed, no further modifications are allowed on the database. The permission to further modify the data rests with a privileged few, most critical study personnel.

63.What Is Edc?

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The process of collection of data into a persistent form. This includes data entry (keyboard EDC, voice recognition, pen-based systems) and automated(or direct) data acquisition(bar code scanners, blood pressure cuff devices etc).

64.What Is Rdc?

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Remote Data Capture. RDC involves the data entry through networked systems like internet.

65.What Does Part 11 Describe?

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Electronic Records and Electronic signatures.

66.What Does Section 11.2 Describes?

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Section 11.2 of 21 CFR Part 11 describes the Implementation.

67.What Is Act?

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Act means the Federal Food Drug and Cosmetics Act ((sec. 201-903) (21U.S.C 321-393) )

68.What Is Biometrics?

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Biometrics means a method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

69.What Is An Electronic Signature?

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Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

70.Define Closed Systems?

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Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

71.What Is The Importance Of Lab Standards?

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lab standards define the exchange of laboratory data between the lab and CRO.

72.What Is Crt Dds?

Ans:

Case Report Tabulation Data Definition Specifications; also known as define .xml, is a standard for providing data definition for case report tabulation in an xml format for submission to FDA. XML is platform neutral and faster to process.

73.What Are The 4 Types Of Data Required By Sdtm For Fda Submission?

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• Analysis data sets.
• Tabulation data sets.
• Patient profiles.
• Listing datasets.

74.Differentiate Between Paper Based Trials And Electronic Trials?

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Paper based Clinical Trials are cumbersome, error prone, inflexible, extensive takes a lot of time. Archival of data is difficult. Electronic trials address all these problems to either eliminate them or to minimize them.

75.What Is Sdv? When Is It Required?

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Source Data Verification and it is required during audit trails, discrepancy management.

76.What Is Aers? What Is It’s Importance?

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Adverse Event Reporting System.Is used to keep track of the adverse events that may occur after a drug is marketed. It could be part of phase IV clinical trials.

77.Define Uadr?

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Unexpected Adverse Drug Reaction. Which is an ADR not documented in a protocol or IB.

78.Define Risk In Clinical Trial?

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The probable harm or discomfort caused to the trial subject.

79.Who Are Vulnerable Subjects?

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• Persons who cannot express willingness to volunteer.
• Persons influenced by expectations Persons with incurable diseases.
• Persons who are unemployed, who belong to ethnic minorities, who are homeless, minors andthose who can’t give consent and emergency patients.

80.What Is Meant By The Well Being Of The Subject?

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The physical and mental integrity of the subject.

81.What Is Compliance?

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Adherence to all regulatory requirements.

82.What Is A Patent?

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A patent is the right granted by a government for any device, substance, or process that is new, inventive, and useful. The patent discloses the knowhow for the invention and in return, the owner of the patent receives a 20 year period of monopoly rights to commercially exploit the invention.

83.What Is The Role Of Irb/iec?

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IRB/IEC (Institutional Review Board/Independent Ethics Committee) acts as a third party to oversee the welfare of the trial subjects and to ensure that the trial is being conducted in accordance with the submitted protocol.

84.Who Are The Members Of Irb/iec?

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IRB/IEC may consist of clinicians, scientists, lawyers, religious leaders, and lay people to represent different view points and protect the rights of the subjects.

85.Who Is A Sponsor?

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The sponsor is the organization or individual that initiates the Ct and finances the study. The organization could be a government department, pharmaceutical company, university or individual. It is normally a pharmaceutical company.

86.What Is A Cro?

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A CRO or Clinical Research Organization is that which is contracted by the sponsor to conduct and monitor the trial. It provides certain measure of independence to the trial and enhances the validity of trial results to be unencumbered by conflict of interest.

87.What Are The Products That Are Regulated By The Fda?

Ans:

• Drugs (e.g., prescriptions, OTCs, generics).
• Biologics (e.g., vaccines, blood products).
• Medical devices (e.g., pacemakers, contact lenses).
• Food (e.g., nutrition, dietary supplements).
• Animal feed and drugs (e.g., livestock, pets).
• Cosmetics (e.g., safety, labeling)
• Radiation emitting products (e.g., cell phones, lasers).

88.What Is The Scope Of 21cfr Part11?

Ans:

• Criteria under which electronic records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
• Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with § 11.2, unless paper records are specifically required.
• Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall bereadily available for, and subject to, FDA inspection.

89.State The 13 Core Principles Of Ich-gcp Guidelines?

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• The clinical trials should be conducted in accordance with the ethical principles based on the declaration of Helsinki and GCP and regulatory requirements.
• Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
• The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

90.What Are The Contents Of An Ind Application?

Ans:

• The name, chemical name and structure of the NCE.
• Complete list of components of the drug Quantitative composition of the drug
• Name and address of the supplier of any new drug substance.

91.What Are The Categories Of Phase Ii Trials?

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Phase IIA and Phase IIB

92.What is PDV?

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The logical area in the memory is represented by PDV or Program Data Vector. At the time, SAS creates a database of one observation at a time. An input buffer is created at the time of compilation which holds a record from an external file. The PDV is created following the input buffer creation.

93.What is a method to debug and test your SAS program?

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You can debug and test your SAS program by using Obs=0 and systems options to trace the program execution in log.

94.What is the difference between INPUT and INFILE ?

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INFILE	INPUT
INFILE statement is used to identify an external file.	INPUT statement is used to describe your variables.

95.What is factor analysis?

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Factor analysis is a common term used for a family of statistical techniques associated with the reduction of a set of observable variables in terms of a small number of latent factors. The main goal of factor analysis is data reduction and summarization.

96.How SAS treats the DSD delimiters?

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When you define DSD, SAS treats two consecutive delimiters as a missing value and removes quotation marks from character values.

97.What are the difference between CEIL and FLOOR functions in SAS?

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The “floor” returns the greatest integer less than/equal to the argument. Whereas the “ceil” function returns the smallest integer greater than/equal to the argument.

98.What are the difference between SAS functions and procedures?

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SAS PROCEDURES	SAS FUNCTIONS
Procedures expect one variable value per observation.	Functions expect values to be supplied across an observation.

99.How will you generate test data with no input data?

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You will generate test data with no input data using “put” statement and “Data Null”.

100.What is the use of STOP statement?

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A STOP statement is used to control the continuous looping in SET statement.