Topics covered
- ICH GCP principles
- Trial phases and design
- Informed consent
- Ethics committee roles
- Essential documents
10 Clinical Research MCQs with answers
- Q1
ICH GCP is described in:
- AE6(R2)/E6(R3)
- BQ7
- CQ9
- DE2B
Explanation: ICH E6 (Good Clinical Practice) — current versions R2 and R3.
- Q2
Phase I trials primarily assess:
- AEfficacy
- BSafety, tolerability, PK
- CPost-marketing surveillance
- DComparative effectiveness
Explanation: Phase I evaluates safety, tolerability, and pharmacokinetics in small healthy volunteers (or patients for oncology).
- Q3
Informed Consent must be obtained:
- AAfter enrollment
- BBefore any study procedure
- COnly for Phase III
- DOnly for vulnerable subjects
Explanation: Informed consent precedes any study-related activity per ICH GCP.
- Q4
IRB / IEC stands for:
- AInstitutional Review Board / Independent Ethics Committee
- BInternational Research Body / International Ethics Council
- CInvestigator Reporting Board
- DIndustry Research Board
Explanation: IRB (US) and IEC (other regions) provide ethical review of clinical research.
- Q5
CRF stands for:
- ACase Report Form
- BClinical Research File
- CCompliance Reporting Form
- DCase Recording Folder
Explanation: CRF captures protocol-required information per subject.
- Q6
Phase IV trials are conducted:
- ABefore approval
- BPost-marketing
- CDuring Phase II
- DOnly on animals
Explanation: Phase IV (post-marketing) studies monitor long-term safety and effectiveness.
- Q7
Investigator's Brochure provides:
- AMarketing claims
- BClinical and nonclinical data of the IMP
- COnly manufacturing data
- DOnly labeling
Explanation: IB compiles all relevant clinical and nonclinical data on the investigational medicinal product.
- Q8
Source data verification (SDV) is done by:
- ASponsor's monitor
- BPatient
- CPharmacist
- DSales rep
Explanation: Clinical Research Associates (monitors) perform SDV on behalf of the sponsor.
- Q9
Randomization in clinical trials minimizes:
- ASelection bias
- BLab errors
- CStorage cost
- DDrug cost
Explanation: Randomization reduces selection bias and confounding.
- Q10
Double-blind means:
- ABoth investigator and subject are unaware of treatment assignment
- BOnly investigator is unaware
- COnly patient is unaware
- DSponsor is unaware
Explanation: Both parties are blinded to treatment to reduce bias.
Take the full Clinical Research test
The complete bank has 100 questions with a 30-minute timer, instant scoring and full answer review in the Quiz Engine.