Get 50+ SAS CDM Interview Questions and Answers

1.What are phases of a clinical trials?

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

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

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

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

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

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

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Can definitely make use of a PROC COMPARE in order to validate a data listing that is entered into the listings manually with help of this condition.

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

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

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

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

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

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

8.What is meant by a PROCS?

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

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

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

10.What is a SAS documentation?

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

11.Explain a Oracle clinical and Clin-trial database?

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

12.What is a SDTM?

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

13.Explain a CRT?

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

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

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

15.Explain contents included in a lab data?

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

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

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

17.How to create a CRTs?

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

18.Explain main difference between the validation and verification?

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

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

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

20.Explain a PROC CDISC in SAS CDM?

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

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

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

22.Who Is a Father Of Clinical Trials?

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James Lind.

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

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A Clinical Research, a Clinical Study, a Medical Research.

24.Define an Unapproved Therapeutic Goods?

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

25.What Is a Ind?

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

26.Describe a Importance Of a Inclusion And Exclusion Criteria?

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

27.What Is Meant By a Masking Or Blinding?

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

Single Blinding: The subject doesn’t know about a treatment.

Double Blinding: Both researcher and a patient do not know about a treatment.

28.Emphasize an Importance Of Masking/blinding?

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

29.What Is a Placebo?

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

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

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

31.What Are the Pre Clinical Studies?

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

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

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Phase I : A Human Pharmacology Trials.

Phase II : A Therapeutic exploratory trials.

Phase III : A Therapeutic Confirmatory Trials.

Phase IV : A Post marketing Surveillance Trials.

33.Distinguish Between a Double Blind And Double Dummy?

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

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

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A Supportive Care Trial.

35.What Are the Orphan Trials?

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

36.What Are the Pk Parameters?

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

37.What Is an Adme?

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A Absorption, Distribution Metabolism and Excretion.

38.What Is a Bioavailability?

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

39.What Is a Bioequivalence?

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

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

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

41.What Is a 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 a patients who are being treated.

42.What Is an Efficacy?

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The measure of a maximum strength of a drug.

43. What Is a Nce?

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A New Chemical Entity.

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

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By a size of a trial.

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

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

46.What Does a Nuremberg Code State?

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

47.Who Are Observers Of Ich?

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

48.Who Are Participants Of Pharmacovigilance?

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

49.What Is a Need Of Pharmacovigilance?

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

50.Describe a Attributes Of Ae?

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Unrelated: The AE is clearly not related to an intervention.

Unlikely: The AE is doubtfully related to an intervention.

Possible: The AE is may be related to an intervention.

Probable: The AE is likely related to an intervention.

Definite: The AE is clearly related to an intervention.

51.Mention Role Of Principal Investigator (pi)?

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

52.What Is a Ctms?

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

53.What Is a Cdms?

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• Accurate.
• Complete.
• Logical.
• Consistent.

54.What Is a Informed Consent?

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

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

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

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

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

57.What Is a Data?

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

58.What Is a Source Document?

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

59.What Is a Common Data Elements (cde)?

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

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

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Data Analytics: AS a 9 platform.

EDC: a Oracle clinical, a phase forward, a medidata solution etc.

Document management Services: Documentum, Opentext, an adobe solutions etc.

61.Define Digitization?

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

62.What Is a Db Closure?

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

63.What Is an Edc?

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The process of collection of data into the persistent form. This includes a data entry and automated(or direct) data acquisition.

64.What Is a Rdc?

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

65.What Does a Part 11 Describe?

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An Electronic Records and an Electronic signatures.

66.What Does a Section 11.2 Describes?

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Section 11.2 of 21 CFR Part 11 describes an Implementation.

67.What Is a Act?

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

68.What Is a Biometrics?

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Biometrics means a method of verifying the individual’s identity based on measurement of a 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 Electronic Signature?

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

70.Define a Closed Systems?

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

71.What Is an Importance Of Lab Standards?

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lab standards explain the exchange of laboratory data between a lab and CRO.

72.What Is a Crt Dds?

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

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

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

74.Differentiate Between a Paper Based Trials And Electronic Trials?

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

75.What Is a Sdv? When Is It Required?

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

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

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

77.Define an Uadr?

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

78.Define Risk In a Clinical Trial?

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The probable harm or discomfort caused to a trial subject.

79.Who Are the Vulnerable Subjects?

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

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

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The physical and mental integrity of a subject.

81.What Is a Compliance?

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Adherence to all the regulatory requirements.

82.What Is Patent?

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

83.What Is Role Of Irb/iec?

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

84.Who Are Members Of Irb/iec?

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

85.Who Is Sponsor?

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

86.What Is A Cro?

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

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

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

88.What Is a Scope Of 21cfr Part11?

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

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

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

90.What Are Contents Of An Ind Application?

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

91.What Are a Categories Of Phase Ii Trials?

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Phase IIA and a Phase IIB.

92.What is a PDV?

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

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

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Can debug and test a SAS program by using Obs=0 and systems options to trace a program execution in log.

94.What is difference between a INPUT and INFILE ?

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INFILE	INPUT
INFILE statement is used to identify external file.	INPUT statement is used to explain variables.

95.What is a factor analysis?

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

96.How SAS treats a DSD delimiters?

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

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

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

98.What difference between SAS functions and procedures?

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

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

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Will generate a test data with no input data using “put” statement and “Data Null”.

100.What is use of STOP statement?

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