MCQ's -Clinical Research

Clinical research MCQ’s

1. Rationalism implies all except [a] It is the pursuit of knowledge through reasoning. [b] leads to formal truth, which may or may not be materially true. [c] provides hypothesis for testing. [d] does not need empirical proof for its conclusions. Answer –d

2. True meaning of Empiricism is [a] Verication Verication by e!perimentation e!perimentation and observation. [b] "ractice based on opinion rather than evidence. [c] #o role in the pursuit of knowledge. [d] $omplementary to rationalism. Answer –d

3. The null hypothesis [a] Is the opposite of the research hypothesis. [b] "rovides, when re%ected, susupport for the research research hypothesis. [c] Is a tool in the reasoning process. [d] All of the above. Answer &d

4. hich statement is true association of a factor !ith an outcome [a] It is not a proof of causation. [b] 'e(uires 'e(uires further analysis before considering the factor as the cause. [c] )uggests causality if the outcome fails to occur without the factor [d] All the above Answer &d

". hich statement a#out sur$ey is true [a] It is a non&interventional study. [b] It is called case&control if it is retrospective. retrospective. [c] If it is prospective, is also called a cohort study.

[d] All the above Answer –d % &ll is true a#out clinical trials of 'rugs except [a] *hey are interventional studies. [b] *hey are e!periments. [c] *hey can be prospective or retrospective. [d] *hey usually have either parallel&groups or cross&over design. Answer &c

(. Metho'ological lan'mar)s in clinical trials inclu'e [a] +se of placebo as a control. [b] 'andomiation to remove bias in assignment. [c] -asking of treatment identity to remove bias in assessment. [d] All the above Answer –d

*. &ll is true a#out +eclaration of ,elsin)i except [a] It is the current I$ standard of ethics in biomedical e!periments on human sub%ects. [b] It was revised latest in /000 at 1dinburgh. [c] It has an e!planatory note on the use of placebo as control, issued in /00/. [d] It was adopted by the 2-A in 3456. Answer &a

-. The ethics of human experimentation ha$e #een outline' #y except [a] *he 27 in 8eclaration of elsinki [b] India in the I$-' guidelines [c] *he $8)$7 in its 9$" guidelines [d] *he +) :8A in its 9$" guidelines Answer &a

1. /C0 or goo' clinical practice [a] Is applicable only to clinical trials of drugs and devices.

[b] Aims to protect the rights and safety of the research sub%ects. [c] 8oes not aim to prevent fraud and misconduct. [d] Is outlined in I$: document 1;. Answer –b

11 hich of the follo!ing !oul' you most often associate 0hase  Trials !ith [a] uman "harmacology [b] *herapeutic +se [c] *herapeutic $onrmatory [d] *herapeutic 1!ploratory Answer –b

12 n !hich clinical phase !oul' you generally expect the trials to #e con'ucte' in a group of patients !ho are selecte' #y relati$ely narro! criteria lea'ing to a relati$ely homogeneous population !hich are closely monitore' 'uring the trial an' the trial is examining therapeutic e5cacy [a] "hase I [b] "hase II [c] "hase IIIa [d] "hase IIIb Answer –b

13 0hase  clinical trial loo) at the pharmaco)inetics of a test pro'uct. hichof the follo!ing statements is not true a#out pharmaco)inetics [a] "harmacokinetics looks at whether the product demonstrates e
14 & recent 'e$elopment in Clinical Trial 0hases has #een the concept of  0hase  Trials. hich of the follo!ing coul' potentially #e classi6e' as 0hase  [a] "re&clinical animal testing [b] :irst&in&man to study the pharmacokinetics and drug target e=ects of a low subtherapeutic dose [c] :irst&in&man trials for medical devices [d] *rials using human tissue collected from patients but not conducted in the patient Answer –b

1" 0hase  trials often loo) at &+ME of a pro'uct. The &+ME is sometimes exten'e' an' referre' to as 7&+ME. hat 'oes the 7 stan' for [a] >oading [b] >imiting [c] >iberation

TU [d] >imited S Answer –c