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SOCRA - CCRP (high level) Exam With Correct Answers
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SOCRA - CCRP (high level) Exam WithCorrect Answers
Nuremberg nnCode nn(1947) nn- nnANSWER: nn✔ nnA nnresearch nnethics nncode nnthat nnarose nnin nnresponse nnto nnthe
nnNazis' nninhumane nnexperimentation nn(nuremberg nntrials) nn- nnholocaust, nnracial nnhygiene nn/ nneugenics nn/
nnmaster nnrace.
The nnNuremberg nnCode nn- nn10 nnpoints nn- nnANSWER: nn✔ nn1. nnvoluntary
2. nnnecessary nnfor nnresults
3. nnlogical nndesign nnand nnresults
4. nnavoid nnunnecessary nnharm
5. nncannot nnresult nnin nndeath nnor nndisablement
6. nnrisk nnassessment
7. nnprotect nnsubjects nnagainst nnharm
8. nnqualified nninvestigators
9. nnright nnto nnwithdrawal
10. nnright nnto nnend nntrial nnif nnneeded
Belmont nnReport nn(1979) nn- nnANSWER: nn✔ nnThree nncore nnprinciples nnare nnidentified: nnrespect nnfor nnpersons,
nnbeneficence, nnand nnjustice.
Arose nnin nnresponse nnto nnTuskegee nnSyphilis nnStudy nn- nnstudying nnuntreated nnsyphilis nnon nnAfrican-American
nnmen nnunaware nnof nntheir nntrue nncondition nnand nntx nnplan.
Belmont nnReport nn- nndefinitions nnof nncore nn- nnANSWER: nn✔ nn1. nnRespect nnfor nnpersons: nninformed nnconsent
nn+ nnno nndeception
2. nnBeneficence: nnmaximize nnbenefits nnand nnminimize nnrisk
3: nnJustice: nnfair nnprocedures nnconsidering nnrisk nnanalysis.
,Belmont nnReport nn- nncurrent nnrole nn- nnANSWER: nn✔ nnServes nnas nna nnhistorical nndocument nnand nnprovides
nnthe nnmoral nnframework nnfor nnunderstanding nnregulations nnin nnthe nnUnited nnStates nnon nnthe nnuse nnof
nnhumans nnin nnexperimental nnmethods.
Belmont nnReport nn- nnreview nnof nn7 nnitems nnfor nnresearch nntrials nn- nnANSWER: nn✔ nn1. nnIRB nnapproved
2. nnObtain nninformed nnconsent
3. nnEnsure nnunderstanding
4. nnNo nncoercion
5. nnMonitor nnadverse nnevents
6. nnMaintain nnprivacy
7. nnEnsure nnpatients nnreceive nnminimal nncare nnfor nntheir nncondition
Declaration nnof nnHelsinki nn(1964, nn1975) nn- nnANSWER: nn✔ nnSet nnof nnethical nnprinciples nnregarding nnhuman
nnexperimentation nndeveloped nnfor nnthe nnmedical nncommunity nnby nnthe nnWorld nnMedical nnAssociation
nn(WMA)
Good nnClinical nnPractice nn(GCP) nn- nnANSWER: nn✔ nnICH-GCP nnand nnISO-GCP nn(medical nndevice) nnenforces
nnguidelines nnon nnethical nnaspects nnof nna nnclinical nntrial.
Covers nnhuman nnrights, nnstandards nnon nntrial nnconduct, nnroles nnand nnresponsibilities nn(IRB, nnPI, nnsponsor,
nnmonitors).
GCP nnv nnDeclaration nnof nnHelinski nn- nnANSWER: nn✔ nnGCP nnlacks nnmoral nnprinciples nnand nnguidance
nnsurrounding nnCOI, nnstudy nndesign, nnbenefits, nnresult nnreporting.
Also nnrestricts nnplacebo nnin nncontrol nngroup nnv nneffective nnalternative nntx
Common nnRule nn- nnANSWER: nn✔ nnUS nnfederal nnpolicy nnthat nnspecifies nnethics nnregulations nnfor nnhuman
nnsubjects nnresearch
1. nnICF nnin nnreasonable nnlanguage, nnreasons nnwhy nnthey nnwould nnnot nnwant nnto nnparticipate nnin nnresearch
,2. nnDisclosure nnof nnuse nnof nnde-identified nndata nn/ nnspecimens nnfor nnfuture nnstudies, nncommercial nnprofit,
nnclinically nnrelevant nnresults nndisclosed, nngenome nnsequencing
3. nnConsent nnwaiver nnonly nnif nnresearch nncould nnnot nnbe nncarried nnout nnwithout nnaccessing nn/ nnusing
nninformation nn/ nnspecimens nnin nnan nnidentifiable nnformat. nnPre-screening nnfor nntrial nnpermitted nnif nnable nnto
nnobtain nnoral nnor nnwritten nncommunication nnOR nnaccess nnrecords nn/ nnstored nnbiospecimens.
4. nnExempt nn/ nnLimited nnIRB nnif
- nnrecord nnreview nnboth nnretrospectively nnAND nnpropectively
- nnbenign nnbehavioral nninteractions
- nncollect nnidentifiable nnsensitive nndata nnvia nnadults nnin nnsurveys/interviews
5. nnContinuing nnreview nn- nnnot nnrequired nnif nnexpedited nnlevel
6. nnMulti-instituitional nnresearch nnstudies nnrequired nnto nnuse nn1 nnIRB nn(effective nn01-19-2020)
Title nn21 nnUS nnCode nnof nnFederal nnRegulations nn(11, nn50, nn56, nn312, nn812) nn- nnANSWER: nn✔ nnTitle nn21 nnis
nnpart nnof nnthe nncode nnof nnfederal nnregulations nngoverning nngood nnand nndrugs nnfor nnthe nnFDA, nnDEA, nnand
nnONDCP nn(office nnof nnnational nndrug nncontrol nnpolicy)
11 nn- nne-records nn+ nne-signatures
50 nn- nnprotection nnhuman nnsubjects
56 nn- nnIRB nnthat nnoversee nntrials
312 nn- nndrug nntrial nnrequirements
812 nn- nncontrolled nnsubstances
Title nn21 nnCFR nnPart nn11 nn- nnANSWER: nn✔ nn1. nnControls nn- nnaudits, nnvalidators, nnaudit nntrails, nne-sigs,
nndocumentation nnfor nnsoftware nn+ nnsystems nnprocessing nne-data.
2. nnE-records nncannot nnbe nnillegible, nninaccessible, nnor nncorrupted
, 3. nn"Hard nncopies" nnare nnauthoritative nndocuments nnfor nnregulatory nnpurposes
Title nn21 nnCFR nnPart nn50 nn- nnANSWER: nn✔ nn
The nnNational nnResearch nnAct nnof nn1974 nn- nnANSWER: nn✔ nnEstablished nnthe nnNational nnCommission.
Issued nnin nn1974, nn45 nnCFR nn46 nnraised nnto nnregulatory nnstatus: nn- nnANSWER: nn✔ nnUS nnPublic nnHealth
nnService nnPolicy
Henry nnK. nnBeecher nnArticle nn(1966) nn- nnANSWER: nn✔ nnDetailed nn22 nnpublished nnmedical nnstudies
nnpresenting nnrisk nnto nnsubjects nnwithout nntheir nnknowledge nnor nnapproval.
Beecher's nnarticle nnclearly nndemonstrated nnthat nnunethical nnresearch nnwas nnnot nnconfined nnto nnNazi
nnatrocities.
U.S. nnPublic nnHealth nnService nn(PHS) nnStudy nnof nnUntreated nnSyphilis nn/ nnTuskegee nnSyphilis nnStudy nn(1932-
1972) nn- nnANSWER: nn✔ nnExamined nnthe nnnatural nncourse nnof nnuntreated nnsyphilis nnin nnBlack nnAmerican
nnmen.
All nnwere nnimpoverished nnsharecroppers nnfrom nnMacon nnCounty, nnAlabama, nnwere nnunknowing nnsubjects
nnin nnthe nnstudy; nnthey nnwere nnnot nntold nnthat nnthey nnhad nnsyphilis, nnnor nnwere nnthey nnoffered nneffective
nntreatment nnwhen nnit nnbecame nnavailable nnin nnthe nnlate nn1940s nnwith nnthe nnavailability nnof nnpenicillin.
Willowbrook nnstudies nn(1956-1970) nn- nnANSWER: nn✔ nnChildren nnwith nnintellectual nndisabilities nnwere
nndeliberately nninfected nnwith nnthe nnhepatitis nnvirus
Jewish nnChronic nnDisease nnHospital nnstudy nn(1963) nn- nnANSWER: nn✔ nnLive nncancer nncells nnwere nninjected
nninto nn22 nncognitively nnimpaired nnpatients.
National nnResearch nnAct nn(1974) nn- nnANSWER: nn✔ nnCongress nnpassed nnthis nnact nnin nnresponse nnto nnthe
nnconcern nnon nnprior nnstudies nn(PHS nnSyphilis, nnprisoner nnresearch, nnwillowbrook nnetc)
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