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SOCRA CCRP Exam With Verified Answers
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SOCRA CCRP Exam With Verified Answers
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SOCRA CCRP Exam With Verified AnswersApril nn30 nn1996 nn- nnANSWER: nn✔ nnICH nnGCP nnDevelopment nnDate
Quality nn- nnANSWER: nn✔ nnICH nnQ
Efficacy nn- nnANSWER: nn✔ nnICH nnE
Safety nn- nnANSWER: nn✔ nnICH nnS
Multidisciplinary nn- nnANSWER: nn✔ nnICH nnM
guidance nnfor nnindustry, nnconsolidated nnguideance nn- nnANSWER: nn✔ nnICH nnE nn6
Clinical nnSafety nnData nnManagement nnDefinitions nnand nnStandards nn- nnANSWER: nn✔ nnICH nnE2A
Safety nnpharmacology nnstudies nnfor nnhuman nnpharmaceuticals nn- nnANSWER: nn✔ nnICH nnS7A
Electronic nnrecords, nnelectronic nnsignatures nn- nnANSWER: nn✔ nn21 nnCFR nnPart nn11
Informed nnConsent nn- nnANSWER: nn✔ nn21 nnCFR nnPart nn50
Financial nnDisclosures nn- nnANSWER: nn✔ nn21 nnCFR nnPart nn54
Institutional nnReview nnBoard nn- nnANSWER: nn✔ nn21 nnCFR nnPart nn56
IND nnApplication nn- nnANSWER: nn✔ nn21 nnCFR nn312
,New nnDrug nnApplication nn- nnANSWER: nn✔ nn21 nnCFR nn314
Investigational nnDevice nnExemption nn- nnANSWER: nn✔ nn21 nnCFR nn812
21 nnCFR nnPart nn814 nn- nnANSWER: nn✔ nnpre nnmarket nnapproval nnof nnmedical nndevices
45 nnCFR nnPart nn46 nn- nnANSWER: nn✔ nnFederal nnResearch
Studies nnthat nninvestigate nnthe nnpotential nnundesirable nnPD nneffects nnof nna nnsubstance nnon nnphysiological
nnfunctions nnin nnrelation nnto nnexposure nnin nnthe nntherapeutic nnrange nnor nnabove nn- nnANSWER: nn✔ nnSafety
nnPharmacology nnStudies nn(Pre-Clinical)
1) nnTo nnIdentify nnundesirable nnPD nnproperties nnof nna nnsubstance nnthat nnmay nnhave nnrelevance nnto nnits
nnhuman nnsafety. nn
2) nnTo nnevaluate nnadverse nnPD nnand/or nnpathophysio nneffects nnof nna nnsubstance nnobserved nnin nntoxicology
nnstudies
3)to nninvestigate nnthe nnmechanism nnof nnthe nnadverse nnPD nneffects nnobserved nnand/or nnsuspected nn-
nnANSWER: nn✔ nnDrug nnDevelopment nnSafety nnPharmacology nnStudy nnObjectives nn(3)
1) nnCardiovascular
2)Respiratory
3)CNS nn- nnANSWER: nn✔ nnThree nnvital nnorgan nnconsidered nnhighest nnpriority
1) nnPK nnand nntoxicokinetic
2) nnSingle nndose nntoxicity
3) nnRepeated nndose nntoxicity
4) nnLocal nntolerance
5) nnGenotoxicity
6) nnCarcinogenicity
, 7) nnReproduction nntoxicity
8) nnSupplemental nnstudies nnif nnneeded nn- nnANSWER: nn✔ nnTypes nnof nnNon-Clinical nnStudies nn(Animal nnTrials)
Study nnthat nninvestigates nnthe nnmode nnof nnaction nnand/or nneffects nnof nna nndrug nnsubstance nnin nnrelation nnto
nnits nndesired nntherapeutic nntarget nn- nnANSWER: nn✔ nnPrimary nnPharmacodynamic nnStudies
Studies nnthat nninvestigate nnthe nnmode nnof nnaction nnand/or nneffects nnof nna nndrug nnsubstance nnnot nnrelated
nnto nnits nndesire nntherapeutic nntarget nn- nnANSWER: nn✔ nnSecondary nnPharmacodynamic nnStudies
Blood nnPressure
Heart nnRate
ECG/EKG
Repolarization/conductance nnabnormalities nn- nnANSWER: nn✔ nnCore nnBattery nnfor nnCardiovascular nnSystem
Respiratory nnRate
Functional nnAssessments nn(tidal nnvolume, nnhgb nnOxygen nnsaturation) nn- nnANSWER: nn✔ nnCore nnBattery nnfor
nnRespiratory nnSystem
Motor nnactivity
behavioral nnchanges
coordination
sensory/motor nnreflex nnresponse
temperature nn- nnANSWER: nn✔ nnCore nnBattery nnfor nnCentral nnNervous nnSystem
Investigational nnNew nnDrug nnApplication
FDA nn- nnANSWER: nn✔ nnBefore nnclinical nntrials nncan nnbe nninitiated, nnan nnapplication nncontaining nnthe
nnappropriate nninformation nnmust nnbe nnsubmitted nnto nnregulatory nnauthorities, nnin nnthe nnUSA nnthis nnis
nncalled nnXXXX nnand nnsubmitted nnto nnthe nnXXX nn(21 nnCFR nnPart nn312)
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