Clinical Data Management Interview Questions & Answers

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Clinical Data Management Interview Questions & Answers

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Clinical Data Management Interview Questions

Clinical Data Management Interview Questions
    1. Question 1. Being A Cd Manager, What Is Your Contribution Going To Be, To My Company?

      Answer :

      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.

    2. Question 2. Who Is The Father Of Clinical Trials?

      Answer :

      James Lind

    3. Question 3. In Health Care, Can You Tell Me The Synonyms Of Ct?

      Answer :

      Clinical Research, Clinical Study, Medical Research

    4. Question 4. Define The Ct?

      Answer :

      Clinical Trials are the comparative study of Medication against the patient’s health condition.

      A more comprehensive definition according to ICH is:

      Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other Pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.

    5. Question 5. Define Unapproved Therapeutic Goods?

      Answer :

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

    6. Question 6. What Is Ind?

      Answer :

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

    7. Question 7. Describe The Importance Of Inclusion And Exclusion Criteria?

      Answer :

      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.

    8. Question 8. What Is Meant By Masking Or Blinding?

      Answer :

      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

    9. Question 9. Emphasize The Importance Of Masking/blinding?

      Answer :

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

    10. Question 10. What Is Placebo?

      Answer :

      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.

    11. Question 11. What Is A Patient File? What Information Is Available In It?

      Answer :

      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

    12. Question 12. What Are Pre Clinical Studies?

      Answer :

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

    13. Question 13. Explain The Different Phases Of Clinical Trials?

      Answer :

      There are four major phases in a clinical trial.

      Phase I : Human Pharmacology Trials

      Phase II : Therapeutic exploratory trials

      Phase III : Therapeutic Confirmatory Trials

      Phase IV : Post marketing Surveillance Trials

      There are different phases of CT

      Pre Clinical Studies: They involve in-vitro studies and in-vivo studies on animals. Wide ranging doses are given to animals and the PK, efficacy and toxicity parameters are studied to determine the viability of further studies. 

      Phase 0: Human Micro Dosing Studies (normally the doses are 100 times less than the intended therapeutic doses). Single sub therapeutic doses are administered to a small number of subjects (10-15) PK and PD parameters are derived.Gives no data on safety or efficacy. To support basic go/no go decision making.

      Phase I: Human Pharmacology Trials. Size - 20 to 80. May range from several months to a year Usually to test one or more of

      combination of objectives.

      1. Maximum tolerated dose

      2. PK

      3. PD

      4. Early measurement of Drug activity

      This phase also includes SAD, MAD and FOOD EFFECT studies.

      Phase II:Therapeutic exploratory trials to determine the effective dose and the dosing regimen.May last from 1 to 2 years.Conducted after safety of the drug is confirmed in phase I. Sample size is larger, between 20-300 Sometimes divided into Phase IIA To assess Dosing requirements. Phase IIB to study efficacy.

      Phase III: Therapeutic confirmatory trials are randomized, controlled, multicentered trials. Also called pivotal trials because they are crucial to the approval of the drug. May last from 3 to 5 years. Aimed at being definitive assessment of effectiveness of drug in comparison with the current gold standard treatment Sample size 300 – 3000

      Phase IV: Post marketing surveillance studies. Either required by the regulatory authorities or undertaken by the manufacturer for competitiveness To gather information like use of Drug in children Pregnant women, children Elderly patients Patients with renal or other failures Specific concomitant

    14. Question 14. Describe The Scientific Names For All 4 Phases Of Trials?

      Answer :

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

    15. Question 15. Distinguish Between Double Blind And Double Dummy?

      Answer :

      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.

    16. Question 16. Other Name For Qol (quality Of Life) Trial?

      Answer :

      Supportive Care Trial.

    17. Question 17. What Are Orphan Trials?

      Answer :

      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.

    18. Question 18. What Are Pk Parameters?

      Answer :

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

    19. Question 19. What Is Adme?

      Answer :

      Absorption, Distribution Metabolism and Excretion

    20. Question 20. What Is Bioavailability?

      Answer :

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

    21. Question 21. What Is Bioequivalence?

      Answer :

      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.

    22. Question 22. Is It True That Phase I Trials Include Healthy Volunteers?

      Answer :

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

    23. Question 23. What Is The Range Of Participants In Each Of The Four Phases Of Clinical Trials?

      Answer :

      Phase I - 20 to 80

      Phase II - 200 - 300

      Phase III - 300 to 3000

      Phase IV - Thousands of patients who are being treated

    24. Question 24. What Are The Categories Of Phase I Trials?

      Answer :

      • SAD(Single Ascending Dose)
      • MAD(Multiple Ascending Dose) and Food Effect

    25. Question 25. What Are The Reasons For Failure Of Different Phases Of Trials?

      Answer :

      Reasons for failure of Phase I trials:

      1. Pre-clinical animal models not equal to behavior in humans
      2. Inadequate pre-clinical data
      3. Change in drug formulation from pre-clinical testing to clinical testing
      4. PK/PD relationship
      5. Poorly designed clinical studies
      6. Drug too toxic in humans

      Reasons for failure in phase II and Phase III trials:

      1. Infrequent ADR s
      2. Drug-drug interaction
      3. Drug-disease interaction 
      4. Genetic
      5. Effectiveness insufficient
      6. Economic

    26. Question 26. What Are The Categories Of Phase Ii Trials?

      Answer :

      Phase IIA and Phase IIB

    27. Question 27. What Is Efficacy?

      Answer :

      The measure of the maximum strength of the drug

    28. Question 28. What Is Potency?

      Answer :

      The amount of drug required for its specific effect.

    29. Question 29. What Is Nce?

      Answer :

      New Chemical Entity

    30. Question 30. What Are The Contents Of An Ind Application?

      Answer :

      • 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
      • Description of synthesis of any new drug substance
      • Statement of methods, facilities and controls used in manufacture and packaging of the new drug
      • Statement covering all information from pre-clinical studies and any clinical studies and experiences With the drug
      • Copies of labels for the drug.
      • Description of scientific training and experience considered appropriate by the sponsor to qualify the investigator as a suitable expert to investigate the drug 
      • Names and curriculum vitae of all the investigators
      • An outline of planned methodology to be adopted for the clinical trial

    31. Question 31. What Are The Contents Of An Nda Application?

      Answer :

      1. Detailed reports of pre-clinical studies
      2. Detailed reports of clinical studies
      3. Information on composition and manufacture of the drug and on controls and facilities used in manufacture
      4. Samples of drug and its labeling
      5. Full case reports of the persons who received the drug, needed only in limited circumstances
      6. Patient information
      7. Material previously submitted to FDA in the IND application or in periodic reports must be included by reference in the NDA

    32. Question 32. List The Responses Of Fda On And Nda(new Drug Application)?

      Answer :

      1. Not Approvable
      2. Approvable
      3. Approval

    33. Question 33. How Can One Tell The Significance Or Power Of A Trial?

      Answer :

      By the size of the trial

    34. Question 34. List The Tripartite Countries In The Ich-gcp?

      Answer :

      USA , European Union and Japan

    35. Question 35. Describe The Incidents That Led To The Formation Of Ethical Principles In Clinical Trials?

      Answer :

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

    36. Question 36. What Does The Declaration Of Helsinki Say?

      Answer :

      The Declaration of Helsinki (1964) defines rules for "research combined with clinical care" & "non-therapeutic research" they are

      1. Research on human beings should be based on the results from laboratory and animal experimentations
      2. Research protocols should be reviewed by an independent committee prior to initiation
      3. Informed consent from research participants is necessary
      4. Research should be conducted by medically scientifically qualified individuals
      5. Risks should not exceed benefits

    37. Question 37. What Does Nuremberg Code State?

      Answer :

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

    38. Question 38. List The Salient Feature Of Belmont Report?

      Answer :

      The three basic principles of Belmont report are

      1. Respect for persons Respect for persons incorporates at least two ethical convictions:

      a. Individuals should be treated as autonomous agents
      b. Persons with diminished autonomy are entitled to protection
      c. Informed consent (3 elements)

      • Information
      • Comprehension
      • Voluntary ness

      d. Subject should be given opportunity to choose what should and shall not happen to them

      2. Beneficence:

      • Human subject should not be harmed
      • Research should maximize the benefits and minimize the harms 
      • Risks and benefits should be assessed
      • The nature and scope of risks and benefits must be systematically assessed.

      3 . Justice:

      • The benefits and risks of the research must be distributed uniformly
      • Selection of subject: there must be a fair process and outcomes in the selection of research subjects

    39. Question 39. State The 13 Core Principles Of Ich-gcp Guidelines?

      Answer :

      1. The clinical trials should be conducted in accordance with the ethical principles based on the declaration of Helsinki and GCP and regulatory requirements
      2. 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.
      3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
      4. Available clinical and non clinical information on the product should adequate to support the proposed clinical trial
      5. Trial should be scientifically sound and described in a clear, detailed protocol
      6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favorable opinion.
      7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.
      8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s)
      9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.
      10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
      11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s)
      12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). Theyshould be used in accordance with the approved protocol.
      13. Systems with procedures that assure the quality of every aspect of thetrial should be implemented

    40. Question 40. Who Are The Observers Of Ich?

      Answer :

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

    41. Question 41. What Are The Objectives Of Ich?

      Answer :

      The purpose of ICH is to make recommendations on ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines.

      To provide a unified standard for the European Union (EU), Japan and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

    42. Question 42. Who Are The Participants Of Pharmacovigilance?

      Answer :

      1. Patients as the users of medicines
      2. 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
      3. Pharmaceutical companies and companies importing or distributing medicines

    43. Question 43. What Is The Need Of Pharmacovigilance?

      Answer :

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

    44. Question 44. Describe The Attributes Of Ae?

      Answer :

      1. Unrelated: The AE is clearly not related to the intervention
      2. Unlikely: The AE is doubtfully related to the intervention
      3. Possible: The AE is may be related to the intervention
      4. Probable: The AE is likely related to the intervention
      5. Definite: The AE is clearly related to the intervention

    45. Question 45. Schedule Y Requirements According To Sae?

      Answer :

      Unsuspected adverse events are communicated from:

      1. Sponsor to regulatory authorities within 14 days
      2. Investigator to sponsor within 24 hours
      3. Investigator to ethics committee in 7 days

    46. Question 46. Role Of Principal Investigator (pi)?

      Answer :

      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.

    47. Question 47. What Is Ctms?

      Answer :

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

    48. Question 48. What Is Cdms?

      Answer :

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

      1. Accurate
      2. Complete
      3. Logical
      4. Consistent

      The trial data collected at the investigator site is stored in a CDMS

    49. Question 49. What Is Ib?

      Answer :

      The Investigator's Brochure (IB) is a basic document which is required in a clinical trial According to the FDA regulations (Title 21 CFR 312.23), an Investigator's Brochure must contain:

      1. Description of the drug substance and the formulation
      2. Summary of the pharmacological and toxicological effects
      3. Summary of information relating to its safety and effectiveness in humans
      4. Description of possible risks and adverse reactions to be anticipated, and the precautions or special monitoring that the investigator should take.

    50. Question 50. What Is Protocol Document?

      Answer :

      A Clinical Trial Protocol is a document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical trial.

      • The existence of a clinical trial protocol allows researchers at multiple locations (in a multi-center trial) to perform the study in exactly the same way, so that their data can be combined as though They were all working together.
      • The protocol also gives the study administrators (often a contract research organization) as well as the local researchers a common reference document for the researchers' duties and responsibilities During the trial.

    51. Question 51. What Are The Means Of Recruiting Subjects For A Clinical Trial?

      Answer :

      1. Throughvolunteer database
      2. Radio advertisements
      3. News paper advertisements
      4. TV advertisements
      5. Internet recruitment
      6. By posting notices at the places like to be visited by patients like clinics, pharmacies etc

    52. Question 52. What Is Informed Consent?

      Answer :

      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.

    53. Question 53. Why Is Randomization Required In A Trial?

      Answer :

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

    54. Question 54. What Is Crf And What Is It’s Importance?

      Answer :

      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.

    55. Question 55. What Is Data?

      Answer :

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

    56. Question 56. What Is Source Document?

      Answer :

      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.

    57. Question 57. What Are The Documents Required To Be Kept At The Study Site?

      Answer :

      Here is a list documents that need to be kept at the study site. 
      1. Signed FDA form 1572
      2. CVs of all investigators
      3. Signed approved protocol
      4. Informed consents / all amended informed consents
      5. Investigator’s Brochure
      6. IRB approval
      7. IRB membership
      8. Assurance number
      9. Drug accountability
      10. IND safety reports
      11. Annual/interim reports
      12. All information given to the subjects
      13. CRF s on each subject (signed, dated)
      14. AE reports
      15. All source documents not kept in Medical record
      16. Meeting minutes/correspondence
      17. Signature log/equipment logs
      18. Laboratory documentation a. Certification
      Abnormal range table with dates
      19. Specimen handling
      a. Instructions/labels/shipping
      20. Staff education records
      21. Financial agreements
      a. Sponsor 
      b. Subject
      22. study agreement grant
      23. Letter of indemnification
      24. Advertisements
      25. End of study report

    58. Question 58. What Is Common Data Elements (cde)?

      Answer :

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

    59. Question 59. What Is Audit Trail?

      Answer :

      It is the data which shows that the study was conducted according to the protocol. It tells the who, when and why of the entry/changes in data.

      It is the also defined as the "Documentation that allows reconstruction of the course of events" according to SCDM (Society for Clinical Data Management).

    60. Question 60. What Is Double Data Entry? What Is It’s Importance?

      Answer :

      Double data entry is the process of entering the same data twice in pass one and pass two, by two different individuals. DDE is important because it helps in reducing the discrepancies that arise due to errors in data entry.

    61. Question 61. What Are The Best Solutions For Clinical Data Management?

      Answer :

      Data Analytics: AS 9 platform

      EDC: Oracle clinical, phase forward, medidata solution etc

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

    62. Question 62. Define Digitization?

      Answer :

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

    63. Question 63. What Is Db Closure?

      Answer :

      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.

    64. Question 64. What Is The Best Analytical Tool?

      Answer :

      SAS 9.0 environment

    65. Question 65. What Is Discrepancy Resolution? Describe The Process?

      Answer :

      As a result of batch validation, the discrepancies that arise in the database are managed by the discrepancy management team.

      1. Discrepancies are resolved through the Data Clarification Form (DCF) or the Data Query Form (DQF).
      2. DCF is generated and sent to the site (investigator) for clarification.
      3. After the corrected values are received from the investigator as a response to the DCF, the responses are updated in the database.
      4. After ensuring that the data is error free, the database is locked to avoid further unauthorized Modifications.

    66. Question 66. What Is Edc?

      Answer :

      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)

    67. Question 67. What Is Rdc?

      Answer :

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

    68. Question 68. What Is The Scope Of 21cfr Part11?

      Answer :

      1. Criteria under which electronic records and signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures.
      2. part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to  electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part
      3. Does not apply to paper records that are, or have been, transmitted by electronic means.
      4. 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.
      5. Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall bereadily available for, and subject to, FDA inspection

    69. Question 69. What Does Part 11 Describe?

      Answer :

      Electronic Records and Electronic signatures.

    70. Question 70. What Does Subpart B Describes?

      Answer :

      Electronic Records (11.10 to 11.70)

      11.10 Controls for closed systems.

      11.30 Controls for open systems.

      11.50 Signature manifestations.

      11.70 Signature/record linking

    71. Question 71. What Does Section 11.2 Describes?

      Answer :

      Section 11.2 of 21 CFR Part 11 describes the Implementation.

    72. Question 72. What Is Act?

      Answer :

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

    73. Question 73. What Is Biometrics?

      Answer :

      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.

    74. Question 74. What Is An Electronic Signature?

      Answer :

      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.

    75. Question 75. Define Closed Systems?

      Answer :

      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.

    76. Question 76. What Do 11.50 Of Part 11 Deal With?

      Answer :

      Signature manifestation

    77. Question 77. What Are The Codes Of Ethics To Be Followed By The Cdm Professionals?

      Answer :

      1. Committed to following the laws and guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity and well being of patients and to maintain the confidentiality of medical records.
      2. Committed to creating, maintaining and presenting quality clinical data, thus supporting accurate and timely statistical analysis, and to adhering to applicable standards of quality and truthfulness in scientific research
      3. Committed to facilitating communication between clinical data management professionals and all other clinical research professionals, to maintaining competency in all areas of clinical data management, to keeping current with technological advances, and to ensuring the dissemination of information to members of the clinical research team.
      4. Committed to working as an integral member of a clinical research team with honesty, integrity and respect. To making and communicating accountability for clinical data management decisions and actions within the clinical trial process. 
      5. Committed to maintaining and respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, and to disclosing any conflict of interest. To avoiding any conduct or behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management
      6. Committed to advancing the profession of clinical data management through the development, distribution and improvement of good clinical data management practices. To aiding the professional development and advancement of colleagues within the clinical trial industry.

    78. Question 78. What Is The Most Recent Version Of Gcdmp Document?

      Answer :

      Version 4

    79. Question 79. Who Is Gcdmp Meant For?

      Answer :

      1. Data managers
      2. Data processors
      3. Statisticians
      4. Site personnel
      5. Clinical professionals
      6. Compliance auditors
      7. Regulatory affairs personnel
      8. All clinical research professionals making decisions regarding or using the clinical trial data

    80. Question 80. How Is Privacy Protection Afforded To The Subjects By Gcdmp?

      Answer :

      1. Protocol review and approval by an Institutional Review Board (IRB)
      2. Right to informed consent
      3. Right of the subject to withdraw consent
      4. Right to notice of disclosure 
      5. Confidential collection and submission of data

    81. Question 81. What Is External Data?

      Answer :

      • Laboratory and PK/PD data
      • Device data (ECG, flowmetry, vital signs, images etc)
      • Electronic patient diaries

    82. Question 82. What Are Ascii Files?

      Answer :

      ASCII stands for American Standard Code for Information Interchange. ASII files are plain text files which can be edited using any simple text editor like notepad.

    83. Question 83. What Is Clean Data?

      Answer :

      clean data means the data is able to support the statistical analysis, and its subsequent Presentation and interpretation, as if the data is error free.

    84. Question 84. What Is The Purpose Of Cdisc?

      Answer :

      To help in streamlining the Clinical data lifecycle by leveraging emerging industry data standards with strong domain and technological expertise. This in turn, helps the sponsor towards production of regulatory grade products throughout all stages of the Clinical Data Lifecycle.

    85. Question 85. Why Do We Need Cdisc?

      Answer :

      To standardize clinical data To bring uniformity and vendor neutrality in clinical data To bring ease and cost effectiveness into data exchangeEasier submission and faster evaluation of CDISC compliant data by the regulatory bodies.

    86. Question 86. List The Standard Models In Cdisc?

      Answer :

      ODM: Operational Data Model. Standards for data storage formats.

      SDTM: Study Data Tabulation Model

      CRT-DDS: Case Report Tabulation Data Definition Specification

      Lab standards: ADaM: Analysis Data Model

      Protocol Standards:

      SEND: Standards for exchange of Non-clinical data

    87. Question 87. What Is The Upcoming Model In Cdisc?

      Answer :

      Protocol Standards

    88. Question 88. Describe Odm Standard?

      Answer :

      1. ODM stands for Operational Data Model.
      2. It defines standards for the storage, archival and exchange of clinical trial data
      3. ODM is vendor and platform independent
      4. ODM includes metadata associated with clinical data, administration data, reference data and audit trails
      5. All information that needs to be shared among different Software systems during setup, operation analysis, submission and long term retention of data
      6. ODM utilizes xml technology

    89. Question 89. What Is The Importance Of Lab Standards?

      Answer :

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

    90. Question 90. What Is Crt Dds?

      Answer :

      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.

    91. Question 91. What Are The 4 Types Of Data Required By Sdtm For Fda Submission?

      Answer :

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

    92. Question 92. What Is Metadata?

      Answer :

      Metadata is data about data.

    93. Question 93. Differentiate Between Paper Based Trials And Electronic Trials?

      Answer :

      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

    94. Question 94. What Is The 21 Cfr For Good Manufacturing Practices (gmp)?

      Answer :

      210 and 211

    95. Question 95. What Is The 21 Cfr For Good Laboratory Practices (glp)?

      Answer :

      58

    96. Question 96. What Is Sdv? When Is It Required?

      Answer :

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

    97. Question 97. What Is Aers? What Is It’s Importance?

      Answer :

      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.

    98. Question 98. Define Uadr?

      Answer :

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

    99. Question 99. Define Risk In Clinical Trial?

      Answer :

      The probable harm or discomfort caused to the trial subject.

    100. Question 100. What Is Safety In Clinical Trial?

      Answer :

      Freedom from harm.

    101. Question 101. What Is Raw Data?

      Answer :

      Records of original observations.

    102. Question 102. Who Are Vulnerable Subjects?

      Answer :

      • 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.

    103. Question 103. What Is Meant By The Well Being Of The Subject?

      Answer :

      The physical and mental integrity of the subject.

    104. Question 104. What Is Compliance?

      Answer :

      Adherence to all regulatory requirements.

    105. Question 105. What Is A Drug?

      Answer :

      FDA Definition of a drug:

      An active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of a disease, or to affect the structure of any function of the human body,but does not include intermediates used in the synthesis of such ingredient.

      More generic definition:

      A drug is substance which provides favorable therapeutic or prophylactic pharmaceutical benefits to the human body

    106. Question 106. What Is A Patent?

      Answer :

      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.

    107. Question 107. What Are The Contents Of The 21 Cfr Part 58 For Glp?

      Answer :

      • Scope 
      • Definitions
      • Applicability to studies performed under grants and contracts
      • Inspection of a testing facility
      • Personnel
      • Testing facility management
      • Study director
      • Quality assurance unit
      • General
      • Animal care facilities
      • Facilities for handling test and control articles
      • Laboratory operation areas
      • Specimen and data storage facilities
      • Equipment design
      • Maintenance and calibration of equipment
      • Standard operating procedures
      • Reagents and solutions
      • Animal care
      • Test and control article characterization
      • Test and control article handling
      • Mixtures of articles with carriers
      • Protocol
      • Conduct of a non-clinical laboratory study
      • Reporting of non-clinical laboratory study results
      • Storage and retrieval of records and data
      • Retention of records 
      • Purpose
      • Grounds for disqualification
      • Notice of and opportunity for hearing on proposed disqualification
      • Final order on disqualification
      • Actions upon disqualification
      • Public disclosure of information regarding disqualification
      • Alternative or additional actions to disqualification
      • Suspension or termination of a testing facility by a sponsor
      • Reinstatement of a disqualified testing facility.

    108. Question 108. What Is The Role Of Irb/iec?

      Answer :

      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.

    109. Question 109. Who Are The Members Of Irb/iec?

      Answer :

      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.

    110. Question 110. What Are The Contents Of A Clinical Trial Protocol?

      Answer :

      According to the ICH GCP, the following information is to be included in a protocol:

      1. Protocol title 
      2. Name and address of Sponsor and Monitor
      3. Name of authorized person
      4. Name of Sponsor’s medical expert
      5. Name of Investigator responsible for the trial
      6. Name of physician responsible for trial - related medical decisions
      7. Name of clinical laboratory and other institutions involved in the trial
      8. Name and description of the clinical trial protocol
      9. Summary of results from nonclinical studies
      10. Potential risks and benefits to human subjects
      11. Description and justification for route of administration, dosage, and treatment plan
      12. Compliance to GCP
      13. Description of the population to be studied
      14. Reference literature and related data
      15. Standard operating procedures

    111. Question 111. Who Is A Sponsor?

      Answer :

      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.

    112. Question 112. What Is A Cro?

      Answer :

      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.

    113. Question 113. What Are The Products That Are Regulated By The Fda?

      Answer :

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

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