Q1.Document mandatory to enrol subject in clinical research study?

A. protocol
B. case report for,
C. informed consent form
D. investigator brochure

Q2.To begin clinical research study it is mandatory to get approval from?

A. Sponsor
B. Regulator
C. Regulators and ethics committee
D. None of the above

Q3.Whose responsibility is to prepare essential documents like protocol/ investigators

brochure/ informed consent form/ case report form in clinical trials?
A. Investigators
B. Ethics Committee
C. Scientist
D. sponsor

Q4. What role can the investigator play in the Ethics Committee review of a study?

A. None-they cant attend

B. They can give information and vote
C. Then can give information but cant vote
D. None of the above

Q5.If a study was described as a "Dose-tolerance study" which of the following is it most
likely to be?

A. Human Pharmacology
B. Therapeutic Exploratory
C. Therapeutic use
D. Therapeutic confirmatory

Q6.Characterisation of a drug's absorption, distribution, metabolism, and excretion is usually

referred to as?

A. Efficacy
B. Safety
C. Pharmacokinetic
D. Pharmacodynamics

Q7.Which type of study would most likely be used to identify less common adverse
reactions?
 A. Human Pharmacology
B. Therapeutic Exploratory
C. Therapeutic use
D. Therapeutic confirmatory

Q8. Distribution records for drug products must reference or contain all of the following
EXCEPT:

A. Name and address of the consignee

B. Name, strength of the product and description of the dosage form
C. Lot or control number and date quantity shipped
D. Purchase order number and date ordered

Q9. Which is true about electronic submissions?

A. If you file an eCTD, all subsequent amendments to the marketing application

must be electronic
B. The FDA does not have a preferred format/file structure for e-submissions
C. Only NDAs may be submitted electronically
D. All FDA divisions accept electronic submissions

Q10.Subacute toxicity testing should be performed?

A. In two rodent species

B. In one rodent and one non-rodent species
C. For a minimum of two weeks
D. For a minimum of six months

Q11.While examining complaint files, a quality assurance practitioner notices that there are
several complaints of microbial contamination of one product lot. To determine the possible
source of the problem, what records should be examined first?

A. Sterilization and water system validations

B. Environmental monitoring
C. Raw material/supplier records
D. Batch or product history record

Q12. Which of the following is NOT a responsibility of clinical investigators?

A. Submitting notices to the IRB of deviations from the investigational plan

B. Maintaining records of receipt, use and disposition of investigational product
C. Reporting to the sponsor withdrawal of IRB approval
D. Submitting unanticipated adverse event reports to regulatory body

Q13. Which of the following does NOT discuss the protection of human subjects?

A. Nuremberg Code
B. Declaration of Helsinki
 C. Drug Amendment of 1962
D. Food Drug and Cosmetic Act of 1938

Q14. The protocol for a non-clinical laboratory study must contain all of the following
EXCEPT:

A. The species, strain and age of the test system

B. The dated signature of the sponsor representative
C. A description of the methods for the control of bias
D. The type and frequency of tests and measurements

Q15. During a monitoring visit, the sponsor discovers that an investigator had used a device
in a clinical investigation without obtaining informed consent from the subject. Which of the
following should the regulatory affairs professional do?

A. Predate the informed consent with a memo to the site file

B. Contact the patient to obtain the informed consent immediately
C. Ensure that the study director from the sponsor discusses the issue with the
investigator
D. Report the protocol deviation to the IRB

Q16. FDA/MHLW/EMEA will do a for-cause inspection of an investigator if the

investigator:

A. Conducts a number of pivotal NDA studies

B. Is only participating in a small number of studies
C. Appears to have an excessive number of study projects
D. Consistently reports results different from other investigators

Q17. A clinical study sponsor's representative conducts periodic monitoring site visits for all
of the following purposes EXCEPT to:

A. Review raw data

B. Ensure compliance with the protocol
C. Review the protocol with the investigator
D. Ensure the adequacy of the IRB and its procedures

Q18. A company is using a clinical research organization (CR0) to develop the protocol and
monitor the clinical investigators for the company's clinical trial. The regulatory affairs
professional may interact with the CR0 in which of the following situations?

A. Making presentations to the reviewing IRBs

B. Making presentations to the reviewing division at FDA
C. Witnessing the signing of patient consent forms
D. Arranging for FDA investigators to observe treatment of subjects at clinical sites

Q19. At what interval are quality assurance audits conducted for nonclinical studies lasting
more than six months?
 A. One month
B. Quarterly
C. At completion
D. Periodically

Q20.What is the best design to study the incidence of a disease?

A. Cross-sectional study
B. Case-control study
C. Cohort study
D. RCT

Q21. Safety Monitoring is done by?

A. Investigator
B. IRB/IECs
C. Sponsor
D. Monitor
E. All of the above.

Q22. Phase I safety monitoring is done in carried out in how many patients?

A. 20-80
B. 100-300
C. 1000-3000
D. None of the above

Q23.List out the methods of collecting adverse events in clinical trials?

A. Volunteer reporting
B. Investigator observation
C. Checklist
D. All of the above

Q24. The responsibilities of a clinical research coordinator are classified as?

A. General responsibilities
B. Trial specific responsibilities
C. None of the above
D. Both A and B

Q25. A huge collection of the information or data accumulated form several different sources
is known as ________

A. Data management
B. Data mining
C. Data warehouse
D. Both B and C