SOCRA PRACTICE TEST QUESTIONS AND
RIGHT ACTUAL ANSWERS 2025 - 2026
Which,of,the,following,is,a,disclosure,of,financial,interests,form?,,ANS,-,FDA,Form,3455
Which,of,the,following,is,a,certification,of,financial,interest,form?,,ANS,-,FDA,Form,3454
If,the,investigator,did,have,financial,arrangement,with,the,sponsor,,he/she,would,submit,the,following,for
m:,,ANS,-,FDA,Form,3455
This,form,is,submitted,by,sponsor,to,the,FDA,prior,to,the,beginning,of,the,drug,trial,,ANS,-
,Investigational,New,Drug,Application,(1571)
In,the,top,right,corner,,form,have,OMB,number.,What,does,it,stand,for?,,ANS,-
,Office,of,Management,and,Budget
The,form,,which,is,submitted,to,the,FDA,to,report,an,Adverse,Event,is,,ANS,-,3500
Medical,device,adverse,events/problems,are,reported,via,a,form:,,ANS,-,3500A
What,is,FDA,form,1571?,,ANS,-,Cover-sheet,for,Investigational,New,Drug,Applications
21,CFR,312,deals,with,,ANS,-,Investigational,New,Drug,Application
Investigational,new,drug,means,,ANS,-,A,new,drug,or,biological,drug,that,is,used,in,a,clinical,investigation
The,immediate,package,of,an,investigational,new,drug,intended,for,human,use,shall,bear,a,label,with,the,
statement,,ANS,-,"Caution:,New,Drug—Limited,by,Federal,(or,United,States),law,to,investigational,use."
Which,of,the,following,is,not,listed,on,FDA,form,1571:,,ANS,-,Approved,informed,consent,document
, "Any,adverse,drug,experience,that,places,the,patient,or,subject,,in,the,view,of,the,investigator,,at,immedi
ate,risk,of,death,from,the,reaction,as,it,occurred",Is...,,ANS,-,Life,threatening,adverse,drug,experience
What,are,the,three,main,basic,ethical,principles,of,the,Belmont,Report?,,ANS,-,1.,Respect,for,Persons
2.,Beneficence
3.,Justice
What,are,the,applications,for,the,Belmont,Report?,,ANS,-,1.,Informed,Consent
2.,Assessment,of,Risk,and,Benefits
3.,Selection,of,Subjects
What,phrase,of,a,drug,trial,usually,includes,hundreds,to,thousands,of,volunteers?,,ANS,-
,Phase,3:,These,studies,gather,more,information,about,safety,and,effectiveness,,study,different,populatio
ns,and,different,dosages,,and,uses,the,drug,in,combination,with,other,drugs.
What,is,a,drug,as,defined,by,the,FDA?,,ANS,-
,A,drug,is,an,product,that,is,intended,for,use,in,the,diagnosis,,cure,mitigation,,treatment,,or,prevention,of,
disease;,and,that,is,intended,to,affect,the,structure,or,any,function,of,the,body.
What,is,Phase,1,of,a,clinical,trial?,,ANS,-,20-
80:,Typical,number,of,healthy,volunteers,used,in,Phase,1:,this,phase,emphasizes,SAFETY.
What,is,Phase,2,of,a,clinical,trial?,,ANS,-
,100s:,Typical,number,of,patients,used,in,Phase,2;,this,phase,emphasizes,EFFECTIVENESS
What,is,Phase,3,of,a,clinical,trial?,,ANS,-
,1000's,:Typical,number,of,patients,used,in,Phase.,3.,These,studies,gather,more,information,about,safety,
and,effectiveness,,study,different,populations,and,different,dosages,,and,uses,the,drug,in,combination,wi
th,other,drugs.
What,is,Phase,4,of,a,clinical,trial?,,ANS,-
,Post,Marketing:,Because,it's,not,possible,to,predict,all,of,a,drug's,effects,during,clinical,trials,,monitoring,s
RIGHT ACTUAL ANSWERS 2025 - 2026
Which,of,the,following,is,a,disclosure,of,financial,interests,form?,,ANS,-,FDA,Form,3455
Which,of,the,following,is,a,certification,of,financial,interest,form?,,ANS,-,FDA,Form,3454
If,the,investigator,did,have,financial,arrangement,with,the,sponsor,,he/she,would,submit,the,following,for
m:,,ANS,-,FDA,Form,3455
This,form,is,submitted,by,sponsor,to,the,FDA,prior,to,the,beginning,of,the,drug,trial,,ANS,-
,Investigational,New,Drug,Application,(1571)
In,the,top,right,corner,,form,have,OMB,number.,What,does,it,stand,for?,,ANS,-
,Office,of,Management,and,Budget
The,form,,which,is,submitted,to,the,FDA,to,report,an,Adverse,Event,is,,ANS,-,3500
Medical,device,adverse,events/problems,are,reported,via,a,form:,,ANS,-,3500A
What,is,FDA,form,1571?,,ANS,-,Cover-sheet,for,Investigational,New,Drug,Applications
21,CFR,312,deals,with,,ANS,-,Investigational,New,Drug,Application
Investigational,new,drug,means,,ANS,-,A,new,drug,or,biological,drug,that,is,used,in,a,clinical,investigation
The,immediate,package,of,an,investigational,new,drug,intended,for,human,use,shall,bear,a,label,with,the,
statement,,ANS,-,"Caution:,New,Drug—Limited,by,Federal,(or,United,States),law,to,investigational,use."
Which,of,the,following,is,not,listed,on,FDA,form,1571:,,ANS,-,Approved,informed,consent,document
, "Any,adverse,drug,experience,that,places,the,patient,or,subject,,in,the,view,of,the,investigator,,at,immedi
ate,risk,of,death,from,the,reaction,as,it,occurred",Is...,,ANS,-,Life,threatening,adverse,drug,experience
What,are,the,three,main,basic,ethical,principles,of,the,Belmont,Report?,,ANS,-,1.,Respect,for,Persons
2.,Beneficence
3.,Justice
What,are,the,applications,for,the,Belmont,Report?,,ANS,-,1.,Informed,Consent
2.,Assessment,of,Risk,and,Benefits
3.,Selection,of,Subjects
What,phrase,of,a,drug,trial,usually,includes,hundreds,to,thousands,of,volunteers?,,ANS,-
,Phase,3:,These,studies,gather,more,information,about,safety,and,effectiveness,,study,different,populatio
ns,and,different,dosages,,and,uses,the,drug,in,combination,with,other,drugs.
What,is,a,drug,as,defined,by,the,FDA?,,ANS,-
,A,drug,is,an,product,that,is,intended,for,use,in,the,diagnosis,,cure,mitigation,,treatment,,or,prevention,of,
disease;,and,that,is,intended,to,affect,the,structure,or,any,function,of,the,body.
What,is,Phase,1,of,a,clinical,trial?,,ANS,-,20-
80:,Typical,number,of,healthy,volunteers,used,in,Phase,1:,this,phase,emphasizes,SAFETY.
What,is,Phase,2,of,a,clinical,trial?,,ANS,-
,100s:,Typical,number,of,patients,used,in,Phase,2;,this,phase,emphasizes,EFFECTIVENESS
What,is,Phase,3,of,a,clinical,trial?,,ANS,-
,1000's,:Typical,number,of,patients,used,in,Phase.,3.,These,studies,gather,more,information,about,safety,
and,effectiveness,,study,different,populations,and,different,dosages,,and,uses,the,drug,in,combination,wi
th,other,drugs.
What,is,Phase,4,of,a,clinical,trial?,,ANS,-
,Post,Marketing:,Because,it's,not,possible,to,predict,all,of,a,drug's,effects,during,clinical,trials,,monitoring,s
