CDM INTERVIEW QUESTIONS

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.

Question 2. Who Is The Father Of Clinical Trials?

Answer :

James Lind

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

Answer :

Clinical Research, Clinical Study, Medical Research

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.

Question 5. Define Unapproved Therapeutic Goods?

Answer :

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

Question 6. What Is Ind?

Answer :

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

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.

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

Question 9. Emphasize The Importance Of Masking/blinding?

Answer :

Masking/ Blinding is necessary because it eliminates any bias in the treatment

process being investigated.

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.

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

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.

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.

Maximum tolerated dose

PK

PD

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

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

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.

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

Answer :
Supportive Care Trial.

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.

Paramedic Interview Questions

Question 18. What Are Pk Parameters?

Answer :

Pharmacokinetic parameters determine the characteristics of thedrug’s Absorption,

Distribution, Metabolism and Excretion (ADME).

Question 19. What Is Adme?

Answer :

Absorption, Distribution Metabolism and Excretion

Question 20. What Is Bioavailability?

Answer :

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

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.

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

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

Answer :

Phase I - 20 to 80

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

Answer :

SAD(Single Ascending Dose)

MAD(Multiple Ascending Dose) and Food Effect

Phase II - 200 - 300

Phase III - 300 to 3000

Phase IV - Thousands of patients who are being treated

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

Answer :
Reasons for failure of Phase I trials:

Pre-clinical animal models not equal to behavior in humans

Inadequate pre-clinical data

Change in drug formulation from pre-clinical testing to clinical testing

PK/PD relationship

Poorly designed clinical studies

Drug too toxic in humans

Reasons for failure in phase II and Phase III trials:

Infrequent ADR s

Drug-drug interaction

Drug-disease interaction

Genetic

Effectiveness insufficient

Economic

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

Answer :

Phase IIA and Phase IIB

Question 27. What Is Efficacy?

Answer :

The measure of the maximum strength of the drug

Clinical SAS Interview Questions

Question 28. What Is Potency?

Answer :

The amount of drug required for its specific effect.

Question 29. What Is Nce?

Answer :

New Chemical Entity

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

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

Answer :

Detailed reports of pre-clinical studies

Detailed reports of clinical studies

Information on composition and manufacture of the drug and on controls and

facilities used in manufacture

Samples of drug and its labeling

Full case reports of the persons who received the drug, needed only in limited
circumstances
Patient information

Material previously submitted to FDA in the IND application or in periodic reports

must be included by reference in the NDA

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

Answer :

Not Approvable

Approvable

Approval

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

Answer :

By the size of the trial

Clinical trial management system Interview Questions

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

Answer :

USA , European Union and Japan

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.

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

Research on human beings should be based on the results from laboratory and
animal experimentations

Research protocols should be reviewed by an independent committee prior to

initiation

Informed consent from research participants is necessary

Research should be conducted by medically scientifically qualified individuals

Risks should not exceed benefits

Medical Assistant Interview Questions

Question 37. What Does Nuremberg Code State?

Answer :

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

Question 38. List The Salient Feature Of Belmont Report?

Answer :

The three basic principles of Belmont report are

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

Individuals should be treated as autonomous agents

Persons with diminished autonomy are entitled to protection

Informed consent (3 elements)

Information

Comprehension

Voluntary ness

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

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

Answer :

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.

Available clinical and non clinical information on the product should adequate to
support the proposed clinical trial
Trial should be scientifically sound and described in a clear, detailed protocol

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.

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.

Each individual involved in conducting a trial should be qualified by education,

training, and experience to perform his or her respective task(s)

Freely given informed consent should be obtained from every subject prior to
clinical trial participation.

All clinical trial information should be recorded, handled, and stored in a way that
allows its accurate reporting, interpretation and verification.

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)

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.

Systems with procedures that assure the quality of every aspect of thetrial should
be implemented

Question 40. Who Are The Observers Of Ich?

Answer :

The World Health Organization (WHO)

The European Free Trade Area (EFTA), represented at ICH by Switzerland

Canada, represented at ICH by Health Canada

Paramedic Interview Questions

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

Question 42. Who Are The Participants Of Pharmacovigilance?

Answer :

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

Clinical Laboratory Technician Interview Questions

Question 43. What Is The Need Of Pharmacovigilance?

Answer :

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

Question 44. Describe The Attributes Of Ae?

Answer :

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

Question 45. Schedule Y Requirements According To Sae?

Answer :

Unsuspected adverse events are communicated from:

Sponsor to regulatory authorities within 14 days

Investigator to sponsor within 24 hours

Investigator to ethics committee in 7 days

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.

Question 47. What Is Ctms?

Answer :

A CTMS describes the responsibilities of those involved in running the trial on a

day-to-day basis.

Question 48. What Is Cdms?

Answer :

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

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:

Description of the drug substance and the formulation

Summary of the pharmacological and toxicological effects

Summary of information relating to its safety and effectiveness in humans

Description of possible risks and adverse reactions to be anticipated, and the

precautions or special monitoring that the investigator should take.

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.

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

Answer :

Throughvolunteer database

Radio advertisements

News paper advertisements

TV advertisements

Internet recruitment

By posting notices at the places like to be visited by patients like clinics,

pharmacies etc

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.

Question 53. Why Is Randomization Required In A Trial?

Answer :

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

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.

Question 55. What Is Data?

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

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.

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.

Signed FDA form 1572

CVs of all investigators

Signed approved protocol

Informed consents / all amended informed consents

Investigator’s Brochure

IRB approval

IRB membership
Assurance number

Drug accountability

IND safety reports

Annual/interim reports

All information given to the subjects

CRF s on each subject (signed, dated)

AE reports

All source documents not kept in Medical record

Meeting minutes/correspondence

Signature log/equipment logs

Laboratory documentation a. Certification

Abnormal range table with dates

Specimen handling

Instructions/labels/shipping

Staff education records

Financial agreements

Sponsor

Subject

study agreement grant

Letter of indemnification

Advertisements

End of study report

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.

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).

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.
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.

Question 62. Define Digitization?

Answer :

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

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.

Question 64. What Is The Best Analytical Tool?

Answer :

SAS 9.0 environment

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.

Discrepancies are resolved through the Data Clarification Form (DCF) or the Data
Query Form (DQF).

DCF is generated and sent to the site (investigator) for clarification.

After the corrected values are received from the investigator as a response to the
DCF, the responses are updated in the database.

After ensuring that the data is error free, the database is locked to avoid further
unauthorized Modifications.

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)

Question 67. What Is Rdc?

Answer :

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

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

Answer :

Criteria under which electronic records and signatures are considered trustworthy,
reliable, and generally equivalent to paper records and handwritten signatures.

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

Does not apply to paper records that are, or have been, transmitted by electronic
means.

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

Question 69. What Does Part 11 Describe?

Answer :

Electronic Records and Electronic signatures.

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

Question 71. What Does Section 11.2 Describes?

Answer :

Section 11.2 of 21 CFR Part 11 describes the Implementation.

Question 72. What Is Act?

Answer :

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

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.
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.

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.

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

Answer :

Signature manifestation

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

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.

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

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.

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.

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

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.

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

Answer :

Version 4

Question 79. Who Is Gcdmp Meant For?

Answer :

Data managers

Data processors

Statisticians

Site personnel

Clinical professionals

Compliance auditors

Regulatory affairs personnel

All clinical research professionals making decisions regarding or using the clinical
trial data

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

Answer :

Protocol review and approval by an Institutional Review Board (IRB)

Right to informed consent

Right of the subject to withdraw consent

Right to notice of disclosure

Confidential collection and submission of data

Question 81. What Is External Data?

Answer :

Laboratory and PK/PD data

Device data (ECG, flowmetry, vital signs, images etc)

Electronic patient diaries

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.

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.
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.

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.

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

Question 87. What Is The Upcoming Model In Cdisc?

Answer :

Protocol Standards

Question 88. Describe Odm Standard?

Answer :

ODM stands for Operational Data Model.

It defines standards for the storage, archival and exchange of clinical trial data

ODM is vendor and platform independent

ODM includes metadata associated with clinical data, administration data,
reference data and audit trails

All information that needs to be shared among different Software systems during
setup, operation analysis, submission and long term retention of data

ODM utilizes xml technology

Question 89. What Is The Importance Of Lab Standards?

Answer :

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

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.

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

Question 92. What Is Metadata?

Answer :

Metadata is data about data.

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

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

Answer :

210 and 211

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

Answer :

58

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

Answer :

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

management.

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.

Question 98. Define Uadr?

Answer :

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

protocol or IB.

Question 99. Define Risk In Clinical Trial?

Answer :

The probable harm or discomfort caused to the trial subject.

Question 100. What Is Safety In Clinical Trial?

Answer :

Freedom from harm.

Question 101. What Is Raw Data?

Answer :

Records of original observations.

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.

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

Answer :

The physical and mental integrity of the subject.

Question 104. What Is Compliance?

Answer :

Adherence to all regulatory requirements.

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

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.

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.

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.

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.

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:

Protocol title

Name and address of Sponsor and Monitor

Name of authorized person

Name of Sponsor’s medical expert

Name of Investigator responsible for the trial

Name of physician responsible for trial - related medical decisions

Name of clinical laboratory and other institutions involved in the trial

Name and description of the clinical trial protocol

Summary of results from nonclinical studies

Potential risks and benefits to human subjects

Description and justification for route of administration, dosage, and treatment
plan

Compliance to GCP

Description of the population to be studied

Reference literature and related data

Standard operating procedures

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.

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.

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

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)