Clinical Trial Questions PDF
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This document contains a series of questions related to clinical trials. It covers topics such as the purpose of clinical trials, member requirements of ethics review committees, and the roles of different parties involved, such as investigators, sponsors, and participants. The document also includes questions about different phases of clinical trials.
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Why do researchers conducting clinical trials? To test the effectiveness of a new treatment To evaluate the side effect of a new treatment Both are correct Neither are correct 2. How many members should be there in an EC At least 3 At least 5 Al least 7 There is no specific...
Why do researchers conducting clinical trials? To test the effectiveness of a new treatment To evaluate the side effect of a new treatment Both are correct Neither are correct 2. How many members should be there in an EC At least 3 At least 5 Al least 7 There is no specification 3. What are the document mandatory to enrol in a clinical research Protocol CRF ICF IB 4. What role can the investigator play in the Ethics Committee review of the study/ None , they cant attend They can give information and vote They can give information but may not vote They can vote but cant give any further information about the study 5. Which of the following is not a requirement for EC under ICH GCP guidelines They should have SOPs They should have one member who is independent of the trial site They should not be paid They should make decisions about approvals only at meeting 6. Which of the following would not be considered a lay person for the purpose of EC Membership? A nurse An Accountant A social worker A common man 7. What is the role of an IRB/ IEC To design the protocol of a clinical trial To assess whether a clinical trial is ethical to perform in the given subject population To analyse the data from a clinical trial To assess whether a medical product should be granted a marketing authorization 8. Who is responsible for destruction of unused IMP The sponsor The investigator The subject The pharmacist 9. Who is responsible for communicating with the IEC regarding the study The member Secretary The sponsor The Sponsor and the Investigator The regulatory authority 10. Sometimes researcher in a clinical trial compare the new treatment to The age of participants Placebo An established treatment A new molecule 11. As a clinical trail progress this number usually increases The number of researchers The number of treatments The number of SAEs The number of participants 12. What is the term for research completed in the real world means Research design Filed research Qualitative research Observational research 13. What are researchers required to get before volunteers can participate in the study Results of all screening tests PI confirmation Informed consent form All the above 14. Which phase of trail is usually considered to start with the initiation of studies in which the primary objective is to explore therapeutic efficacy in patients Phase I Phase II Phase III Phase IV 15. ADR Reporting is mandatory during clinical trial Yes No Only if the condition may be serious Only if protocol describes Please explain your answer with a justification point
