The CITI Good Clinical Practice Course for
i i i i i i i
Clinical Trials Involving Drugs and Devices
i i i i i
GeorgeWashington University - GCPEnglish Quiz
i i i i i i i
Results
Youi correctlyi answeredi 3i ofi 3i quizi questions.
Question 1 i
Questioni Whichi ofi thei followingi arei thei threei principlesi includedi ini thei Belmonti Report?
Youri
Respecti fori Persons,i Beneficence,i Justice.
answer
Result Correct
Thei Belmonti Report’si basici ethicali principlesi includei Respecti fori Persons,i
Commenti
Beneficence,i andi Justice.
Question 2 i
Whichi ofi thei followingi isi ani examplei ofi howi thei Principlei ofi Beneficencei cani bei
Questioni
appliedi toi ai studyi employingi humani subjects?
Youri
Determiningi thati thei studyi hasi maximizedi benefitsi andi minimizedi risks.
answer
Result
Correct
i Comment
Thei Belmonti Report’si principlei ofi beneficencei includesi thei twoi generali rulesi asi
complementaryi expressionsi ofi beneficenti actionsi (1)i doi noti harmi andi (2)i
maximizei possiblei benefitsi andi minimizei possiblei harms.i Providingi detailedi
informationi abouti thei studyi andi obtainingi thei subject’si consenti toi participatei
wouldi bei ani examplei ofi thei principlei ofi respecti fori persons.i Ensuringi thati thei
selectioni ofi subjectsi includesi peoplei fromi alli segmentsi ofi thei populationi wouldi bei
ani examplei ofi thei principlei ofi justice.i Finally,i ensuringi thati confidentialityi isi
maintainedi isi ai regulatoryi requirementi peri HHSi regulationsi 45i CFRi 46.i Ensuringi
confidentialityi couldi bei supportedi byi respecti fori personsi (extendingi thei ideai thati
thei subject’si righti toi autonomyi could
, includei theiri righti toi privacyi andi confidentiality)i andi beneficencei (thati maintainingi
privacyi andi confidentialityi helpsi toi protecti subjectsi fromi potentiali harmsi ofi ai
breachi ofi confidentialityi withi sensitivei information),i buti iti isi noti thei besti responsei
fori thisi questioni sincei iti isi noti directlyi ani examplei ofi thei principlei ofi beneficencei
ini humani subjectsi research.
Question 3 i
Whichi ofi thei followingi besti describesi thei principlei ofi informedi consenti asi
Questioni
describedi ini thei Belmonti Report?
Youri
Information,i comprehension,i voluntariness.
answer
Result Correct
Respecti fori personsi requiresi thati subjects,i toi thei degreei thati theyi arei capable,i bei
giveni thei opportunityi toi choosei whati shalli ori shalli noti happeni toi them.i Thisi
opportunityi isi providedi wheni adequatei standardsi fori informedi consenti arei satisfied.i
Whilei the
Commenti importancei ofi informedi consenti isi unquestioned,i controversyi prevailsi overi thei
naturei andi possibilityi ofi ani informedi consent.i Nonetheless,i therei isi widespreadi
agreementi thati thei consenti processi cani bei analyzedi asi containingi threei elements:i
information,i comprehensioni andi voluntariness.
, Whichi ofi thei followingi arei thei threei principlesi discussedi ini thei Belmonti Report?
Respecti fori Persons,i Beneficence,i Justice.
Whichi ofi thei followingi isi ani examplei ofi howi thei Principlei ofi Beneficencei cani bei appliedi toi ai
studyi employingi humani subjects?
Determiningi thati thei studyi hasi ai maximizationi ofi benefitsi andi ai minimizationi ofi risks.i
Alli ofi thei followingi arei truei regardingi thei Belmonti Report,i EXCEPT:
Thei Belmonti Reporti indicatesi thati iti isi necessaryi toi rigorouslyi avoidi conflictsi ofi interest.i
Thei researcher'si failurei toi protecti researchi subjectsi fromi deductivei disclosurei isi thei
primaryi ethicali violationi ini whichi ofi thei followingi studies?
Harvardi "Tastes,i Ties,i andi Timei (T3)"i studyi (2006-2009)"i study
Whichi ofi thei followingi isi ani examplei ofi howi thei principlei ofi beneficencei isi appliedi toi ai studyi
involvingi humani subjects?
Ensuringi thati risksi arei reasonablei ini relationshipi toi anticipatedi benefits.
Humphreysi collectingi datai fori thei Tearoomi Tradei studyi underi thei pretensei thati hei wasi ai
lookouti isi ani examplei ofi ai violationi ofi thei principlei of:
Respecti fori persons.
Whichi ofi thei followingi studiesi isi linkedi mosti directlyi toi thei establishmenti ofi thei Nationali
Researchi Acti ini 1974i andi ultimatelyi toi thei Belmonti Reporti andi Federali regulationsi fori humani
subjecti protection?
Thei Publici Healthi Servicei Tuskegeei Studyi ofi Untreatedi Syphilisi ini thei Negroi Male.i
Accordingi toi thei Belmonti Report,i thei morali requirementi thati therei bei fairi outcomesi ini thei
selectioni ofi researchi subjects,i expressesi thei principlei of:
Justice.
Thei Belmonti Principlei ofi beneficencei requiresi thati
Potentiali benefitsi justifyi thei risksi ofi harm.
Ai subjecti ini ai clinicali researchi triali experiencesi ai serious,i unanticipatedi adversei drugi
experience.i Howi shouldi thei investigatori proceed,i withi respecti toi thei IRB,i afteri thei discoveryi
ofi thei adversei eventi occurrence?
Reporti thei adversei drugi experiencei ini ai timelyi manner,i ini keepingi withi thei IRB'si policiesi andi
procedures,i usingi thei formsi ori thei mechanismi providedi byi thei IRB.
i i i i i i i
Clinical Trials Involving Drugs and Devices
i i i i i
GeorgeWashington University - GCPEnglish Quiz
i i i i i i i
Results
Youi correctlyi answeredi 3i ofi 3i quizi questions.
Question 1 i
Questioni Whichi ofi thei followingi arei thei threei principlesi includedi ini thei Belmonti Report?
Youri
Respecti fori Persons,i Beneficence,i Justice.
answer
Result Correct
Thei Belmonti Report’si basici ethicali principlesi includei Respecti fori Persons,i
Commenti
Beneficence,i andi Justice.
Question 2 i
Whichi ofi thei followingi isi ani examplei ofi howi thei Principlei ofi Beneficencei cani bei
Questioni
appliedi toi ai studyi employingi humani subjects?
Youri
Determiningi thati thei studyi hasi maximizedi benefitsi andi minimizedi risks.
answer
Result
Correct
i Comment
Thei Belmonti Report’si principlei ofi beneficencei includesi thei twoi generali rulesi asi
complementaryi expressionsi ofi beneficenti actionsi (1)i doi noti harmi andi (2)i
maximizei possiblei benefitsi andi minimizei possiblei harms.i Providingi detailedi
informationi abouti thei studyi andi obtainingi thei subject’si consenti toi participatei
wouldi bei ani examplei ofi thei principlei ofi respecti fori persons.i Ensuringi thati thei
selectioni ofi subjectsi includesi peoplei fromi alli segmentsi ofi thei populationi wouldi bei
ani examplei ofi thei principlei ofi justice.i Finally,i ensuringi thati confidentialityi isi
maintainedi isi ai regulatoryi requirementi peri HHSi regulationsi 45i CFRi 46.i Ensuringi
confidentialityi couldi bei supportedi byi respecti fori personsi (extendingi thei ideai thati
thei subject’si righti toi autonomyi could
, includei theiri righti toi privacyi andi confidentiality)i andi beneficencei (thati maintainingi
privacyi andi confidentialityi helpsi toi protecti subjectsi fromi potentiali harmsi ofi ai
breachi ofi confidentialityi withi sensitivei information),i buti iti isi noti thei besti responsei
fori thisi questioni sincei iti isi noti directlyi ani examplei ofi thei principlei ofi beneficencei
ini humani subjectsi research.
Question 3 i
Whichi ofi thei followingi besti describesi thei principlei ofi informedi consenti asi
Questioni
describedi ini thei Belmonti Report?
Youri
Information,i comprehension,i voluntariness.
answer
Result Correct
Respecti fori personsi requiresi thati subjects,i toi thei degreei thati theyi arei capable,i bei
giveni thei opportunityi toi choosei whati shalli ori shalli noti happeni toi them.i Thisi
opportunityi isi providedi wheni adequatei standardsi fori informedi consenti arei satisfied.i
Whilei the
Commenti importancei ofi informedi consenti isi unquestioned,i controversyi prevailsi overi thei
naturei andi possibilityi ofi ani informedi consent.i Nonetheless,i therei isi widespreadi
agreementi thati thei consenti processi cani bei analyzedi asi containingi threei elements:i
information,i comprehensioni andi voluntariness.
, Whichi ofi thei followingi arei thei threei principlesi discussedi ini thei Belmonti Report?
Respecti fori Persons,i Beneficence,i Justice.
Whichi ofi thei followingi isi ani examplei ofi howi thei Principlei ofi Beneficencei cani bei appliedi toi ai
studyi employingi humani subjects?
Determiningi thati thei studyi hasi ai maximizationi ofi benefitsi andi ai minimizationi ofi risks.i
Alli ofi thei followingi arei truei regardingi thei Belmonti Report,i EXCEPT:
Thei Belmonti Reporti indicatesi thati iti isi necessaryi toi rigorouslyi avoidi conflictsi ofi interest.i
Thei researcher'si failurei toi protecti researchi subjectsi fromi deductivei disclosurei isi thei
primaryi ethicali violationi ini whichi ofi thei followingi studies?
Harvardi "Tastes,i Ties,i andi Timei (T3)"i studyi (2006-2009)"i study
Whichi ofi thei followingi isi ani examplei ofi howi thei principlei ofi beneficencei isi appliedi toi ai studyi
involvingi humani subjects?
Ensuringi thati risksi arei reasonablei ini relationshipi toi anticipatedi benefits.
Humphreysi collectingi datai fori thei Tearoomi Tradei studyi underi thei pretensei thati hei wasi ai
lookouti isi ani examplei ofi ai violationi ofi thei principlei of:
Respecti fori persons.
Whichi ofi thei followingi studiesi isi linkedi mosti directlyi toi thei establishmenti ofi thei Nationali
Researchi Acti ini 1974i andi ultimatelyi toi thei Belmonti Reporti andi Federali regulationsi fori humani
subjecti protection?
Thei Publici Healthi Servicei Tuskegeei Studyi ofi Untreatedi Syphilisi ini thei Negroi Male.i
Accordingi toi thei Belmonti Report,i thei morali requirementi thati therei bei fairi outcomesi ini thei
selectioni ofi researchi subjects,i expressesi thei principlei of:
Justice.
Thei Belmonti Principlei ofi beneficencei requiresi thati
Potentiali benefitsi justifyi thei risksi ofi harm.
Ai subjecti ini ai clinicali researchi triali experiencesi ai serious,i unanticipatedi adversei drugi
experience.i Howi shouldi thei investigatori proceed,i withi respecti toi thei IRB,i afteri thei discoveryi
ofi thei adversei eventi occurrence?
Reporti thei adversei drugi experiencei ini ai timelyi manner,i ini keepingi withi thei IRB'si policiesi andi
procedures,i usingi thei formsi ori thei mechanismi providedi byi thei IRB.
