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Subtopics in this bank
DSMB roles and responsibilitiesEssential documentsEthics committeesIRB/Ethics Committee scope and boundariesInformed consentInformed consent procedures in GCPInvestigator & sponsor dutiesInvestigator's Brochure content and useLaboratory animal ethicsNDCT Rules 2019Phase II and Phase III trial designProtocol & amendmentsSAE reporting and trial continuance decisionsSAE/AE reporting & compensationSource data verification proceduresTrial phases
Sample questions, with the reasoning
Every question in the bank is explained like this — including why each wrong option is wrong.
A Bioavailability/Bioequivalence (BA/BE) study is defined as a clinical trial that evaluates:
A)Only therapeutic efficacy in disease treatment
B)The systemic availability of the active drug from a formulation✓
C)Only manufacturing processes without subject participation
D)Long-term safety after 5 years of treatment
Why B is correct
BA/BE trials are clinical pharmacology studies where human subjects receive the investigational formulation to measure drug absorption (bioavailability) and compare formulations (bioequivalence).
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A new drug has completed phase-I clinical trial in USA. The pharmaceutical company wants to do a multicentric, multinational trial including India. The firm will apply in India to conduct
A)Phase I-trial
B)Phase-II trial
C)Pre-clinical trial
D)Pharmacokinetic bridging trial✓
Why D is correct
Under Schedule Y's provisions for global clinical trials, when Phase I has already been completed abroad, India permits participation in the later-phase multinational trial on the strength of a pharmacokinetic bridging study (comparative PK data in the Indian population) rather than repeating a full local Phase I.
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According to GCP guidelines, the minimum number of members required in the quorum of an Ethics Committee to review a protocol is:
A)5✓
B)6
C)7
D)9
Why A is correct
Indian GCP guidelines require a minimum quorum of 5 members for an Ethics Committee to review a protocol.
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Practise S08 with real marking
50 questions · −1/3 negative marking · explanations after every answer. No sign-up needed to try.