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Potential Interview Questions


1. Define GCPs
International ethical and scientific quality standard for designing, conducting, reporting and
reporting trials that involves participation of human subjects ?


2. ICH GCP Guidelines came into force in the year _____
1997


3. Total number of Principles specified in ICG-GCP Guidelines.
13


4. Define Phases of clinical trials.
Phase I : To establish initial safety and maximum tolerance, pharmacokinetics etc. in 20-80 healthy human
volunteers. Also called as First in Man.
Phase II : Universally accepted as a standard requirement for the evaluation of efficacy and safety of the
drug. Careful observations are made to determine the dose and adverse reactions in 100-200 patients with the
relevant indication e.g. randomized, placebo control, blinded etc.
Phase III: Final pre-marketing phase; multi-centric, several patients; safety and efficacy data to establish a
drug's risk- benefit relationship; the basis of Regulatory submissions.
Phase IV (Post marketing studies) : additional safety data; tests the approved drug for additional conditions;
expand to much larger patient population.


5. Clinical Trial Phase that evaluates Safety only (2)?
Phase I and Phase II


6. An individual or a company or an institution that takes responsibility for the overall trial conduct?
Sponsor


7. Applicable GCP Guidelines in India (3)
1. Ethical Guidelines for Biomedical Research on Human Subjects,2006
2. Schedule Y ( Amended Version-2005) of Drugs and Cosmetics Act,1940
3. Indian GCP,2001


8. Who should comply to GCP (4)?
1. Sponsor/CRO
2. Investigator
3. Regulatory Bodies
4. Ethics Committee



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9. Application filed to regulatory agency for initiating Phase-I clinical trials.
Investigational New Drug (IND) Application


10. Expand EMEA
The European Agency for the Evaluation of Medicinal Products


11. Application filed to regulatory agency for seeking marketing permission
New Drug Application (NDA)


12. Application for seeking clinical trial permission in India is filed in ___ format
Form 44


13. Animal pharmacological data requirements as per Schedule-Y (3)
Specific pharmacological actions, General pharmacological actions, ADME


14. Expand MHRA
Medicines and Healthcare Product Regulatory Agency


15. Clinical Trials Regulatory Authority in India
Drugs Controller General of India (DCGI)


16. Clinical Research Regulations of USA
Code of Federal Regulations (CFR)


17. Regulatory Application for seeking the marketing permission of a generic drug product
ANDA


18. Application for the permission to import investigational product in India is filed in _____
Form 12


19. Animal toxicology data requirements as per Schedule-Y (4)
Male fertility studies, female reproduction studies, genotoxicity studies, carcinogenicity studies


20. Duration of approval for an import license (2)
1 year, Quantity specified in the import license


21. Potential Investigator Sites are Identified on the basis of (3)
Recruitment potential, Qualification/Capabilities of the Investigator, Past clinical trial experience,
Availability of required infrastructure


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22. Names of Master Trial Files (4)
Trial Master File, Investigator Master File, Investigator Site File, Vendor File


23. Essential trial documents before initiating a clinical trial (5)
Protocol, ICF, IB, Translation of ICF, CRF


24. Essential trial documents during the clinical conduct of a trial (5)
Protocol amendment, ICF amendment, IB amendment, EC approval of amendments, CV of new
site personnel


25. Who signs the Informed Consent Form in case of literate subject (2)?
Study subject, Investigator

26. Criteria for a valid SAE Case (4)
Identifiable Reporter, Identifiable patient, Study Drug, Seriousness criteria


27. Criteria that makes an AE as SAE (5)
Death, Life-threatening, Hospitalization, Permanent Disability, Congenital Anomaly


28. EC quorum as per Schedule Y (5)?
1. Basic Medical Scientists (preferably one Pharmacologist)
2. Clinicians
3. Legal Experts
4. Social Scientist (non-science member)
5. Lay person from the community


29. Minimum number of ERB/IRB members as prescribed by ICH-GCP _____ and Schedule Y ____ (2)
5, 7


30. What all constitute source data (5)
Medical notes, Lab reports, Radiographs, ECG tracings, IPD/OPD charts


31. Archival timeframe for ERB/IRB, ICH-GCP _____, Schedule-Y _____ (2)
3 years after completion of study, 5 years after completion of study


32. Monitoring is the act of overseeing the progress of a clinical trial, and of ensuring that it is
conducted, recorded, and reported in accordance with the _____ (4)
Protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable
Regulatory Requirements





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33. Critical Elements of Clinical Trial Monitoring (5)
Source Data Verification/CRF Review, Investigational Product Accountability, Informed Consent
Document (ICD) Review, Serious Adverse Events (SAEs) Review, Protocol Compliance, Regulatory
Compliance, Investigator's Team Training/Re-training, Review of Facility and Resources,
Deviations and Actionable, Record Retention and Archival


34. Review of Facility and Resources includes verifying that ___________ remains adequate throughout
the duration of trial (4)
Laboratories, Equipments, Drug Storage, Staff


35. SAE reporting timelines to ERB (2)
i. ICH-GCP: 7 days
ii. Schedule-Y: 7 working days


36. Other general questions such as:
i. Tell us something about about yourself,
ii. Tell us your education background,
iii. What are your strengths and weakness,
iv. Why you want to join clinical research field,
v. Your interests, achievements, salary expectations etc.