SoCRA /CERTIFICATION EXAM QUESTIONS
AND ANSWERS UPDATED FOR 2024 - 2025
Biometrics,ANS,-
,,A,method,of,verifying,an,individual's,identity,based,on,measurement,of,the,individual's,physical,features,
or,repeatable,actions,where,those,features,and,or,actions,are,both,unique,to,that,individual,and,measura
ble.,(21,CFR,,Sec.,11.3)
Closed,System,ANS,-
,,An,environment,in,which,system,access,is,controlled,by,persons,who,are,responsible,for,the,content,of,el
ectronic,records,that,are,on,the,system.,(21,CFR,,Sec.,11.3)
Digital,Signature,ANS,-
,,An,electronic,signature,based,upon,cryptographic,methods,of,originator,authentication,,computed,by,us
ing,a,set,of,rules,and,a,set,of,parameters,such,that,the,identity,of,the,signer,and,the,integrity,of,the,data,c
an,be,verified.,(21,CFR,,Sec.,11.3)
Electronic,Record,ANS,-
,,Any,combination,of,text,,graphics,,data,,audio,,pictorial,,or,other,information,representation,in,digital,for
m,that,is,created,,modified,,maintained,,archived,,retrieved,or,distributed,by,a,computer,system.,(21,CFR,
,Sec.,11.3)
Electronic,Signature,ANS,-
,,A,computer,data,compilation,of,any,symbol,or,series,of,symbols,executed,,adopted,,or,authorized,by,an,i
ndividual,to,be,legally,binding,equivalent,of,the,handwritten,signature.,(21,CFR,,Sec.,11.3)
Open,system,ANS,-
,,An,environment,in,which,system,access,is,not,controlled,by,persons,who,are,responsible,for,the,content,
of,the,electronic,records,that,are,on,the,system.,(21,CFR,,Sec.,11.3)
Clinical,Investigation,ANS,-
,,Any,experiment,that,involves,a,test,article,and,one,or,more,human,subjects,and,that,either,is,subject,to,r
equirements,for,prior,submission,to,the,Food,and,Drug,Administration,under,section,505(i),or,520(g),of,th
e,act,,or,is,not,subject,to,requirements,for,prior,submission,to,the,Food,and,Drug,Administration,under,th
ese,sections,of,the,Act,,but,the,results,of,which,are,intended,to,be,submitted,later,to,,or,held,for,inspectio
,n,by,,the,Food,and,Drug,Administration,as,part,of,an,application,for,a,research,or,marketing,permit.,(21,CF
R,,sec.,50.3)
Investigator,ANS,-
,,An,individual,who,actually,conducts,a,clinical,investigation,,i.e.,,under,whose,immediate,direction,the,tes
t,article,is,administered,or,dispensed,to,,or,used,involving,,a,subject,,or,,in,the,event,of,an,investigation,co
nducted,by,a,team,of,individuals,,is,the,responsible,leader,of,that,team.,(21,CFR,,sec.,50.3)
Sponsor,ANS,-
,,A,person,who,initiates,a,clinical,investigation,but,who,does,not,actually,conduct,the,investigation,,i.e.,,th
e,test,article,is,administered,or,dispensed,to,,or,used,involving,,a,subject,under,the,immediate,direction,o
f,another,individual.,A,person,other,than,the,individual,(e.g.,,corporation,or,agency),that,uses,one,or,mor
e,of,its,own,employees,to,conduct,a,clinical,investigation,it,has,initiated,it,has,initiated,is,considered,to,be,
a,sponsor,(not,a,sponsor-
investigator),,and,the,employees,are,considered,to,be,investigators.,(21,CFR,,sec.,50.3)
Sponsor-Investigator,ANS,-
,,An,individual,who,both,initiates,and,actually,conducts,,alone,or,with,others,,a,clinical,investigation,,i.e.,,u
nder,whose,immediate,direction,the,test,article,is,administered,or,dispensed,to,,or,used,involving,,a,subje
ct.,The,term,does,not,include,any,other,person,other,than,an,individual,,e.g.,corporation,or,agency.,(21,CF
R,,sec.,50.3)
Handwritten,Signature,ANS,-
,,The,scripted,name,or,legal,mark,of,an,individual,handwritten,by,that,individual.,(21,CFR,,Sec.,11.3)
Act,ANS,-,,The,Food,,Drug,and,Cosmetic,Act,,as,amended.
Human,Subject,ANS,-
,,An,individual,who,is,or,becomes,a,participant,in,research,,either,as,a,recipient,of,the,test,article,or,as,a,co
ntrol.,A,subject,may,be,either,a,healthy,human,or,a,patient.,(21,CFR,,sec.,50.3)
Institution,ANS,-
,,Any,public,or,private,entity,or,agency,(including,Federal,,State,or,other,agencies).,The,word,facility,as,use
d,in,section,520(g),of,the,Act,is,deemed,to,by,synonymous,with,the,term,institution,for,purposes,of,this,pa
rt.(21,CFR,,sec.,50.3)
, Institutional,Review,Board,(IRB),ANS,-
,,Any,board,,committee,,or,other,group,formally,designated,by,an,institution,to,review,biomedical,researc
h,involving,humans,as,subjects,,to,approve,the,initiation,of,and,conduct,periodic,review,of,such,research.,
The,term,has,the,same,meaning,as,the,phrase,institutional,review,committee,as,used,in,section,520(g),of,t
he,act.,(21,CFR,,sec.,50.3)
Test,Article,ANS,-
,,Any,food,or,drug,(including,a,biological,product,for,human,use),,medical,device,for,human,use,,human,fo
od,additive,,color,additive,,electronic,product,,or,any,other,article,subject,to,regulation,under,the,act,or,u
nder,sections,351,,and,354-360F,of,the,Public,Health,Services,Act.,(21,CFR,,sec.,50.3)
Minimal,Risk,ANS,-
,,Means,that,the,probability,and,magnitude,of,harm,or,discomfort,anticipated,in,the,research,are,no,great
er,in,an,of,themselves,than,those,ordinarily,encountered,in,daily,life,or,during,the,performance,of,routine,
physical,or,psychological,examinations,or,tests.,(21,CFR,,sec.,50.3)
Legally,Authorized,Representative,ANS,-
,,An,individual,or,judicial,or,other,body,authorized,under,applicable,law,to,consent,on,behalf,of,a,prospect
ive,subject,to,the,subject's,participation,in,the,procedures,involved.,(21,CFR,,sec.,50.3)
Family,Member,ANS,-
,,Any,one,of,the,following,legally,competent,persons:,spouse;,parents;,children,(including,adopted,childre
n);,brothers,,sisters,and,spouses,of,brothers,and,sisters;,and,any,individual,related,by,blood,or,affinity,wh
ose,close,association,with,the,subject,is,equivalent,of,a,family,relationship.,(21,CFR,,sec.,50.3)
Assent,ANS,-
,,A,child's,affirmative,agreement,to,participate,in,a,clinical,investigation.,Mere,failure,to,object,may,not,,a
bsent,affirmative,agreement,,be,construed,as,assent.,(21,CFR,,sec.,50.3)
Children,ANS,-
,,Persons,who,have,not,attained,the,legal,age,for,consent,to,treatment,or,procedures,involved,in,clinical,in
vestigations,,under,the,applicable,law,of,the,jurisdiction,in,which,the,clinical,investigation,will,be,conduct
ed.,(21,CFR,,sec.,50.3)
Parent,ANS,-,,A,child's,biological,or,adoptive,parent.,(21,CFR,,sec.,50.3)
AND ANSWERS UPDATED FOR 2024 - 2025
Biometrics,ANS,-
,,A,method,of,verifying,an,individual's,identity,based,on,measurement,of,the,individual's,physical,features,
or,repeatable,actions,where,those,features,and,or,actions,are,both,unique,to,that,individual,and,measura
ble.,(21,CFR,,Sec.,11.3)
Closed,System,ANS,-
,,An,environment,in,which,system,access,is,controlled,by,persons,who,are,responsible,for,the,content,of,el
ectronic,records,that,are,on,the,system.,(21,CFR,,Sec.,11.3)
Digital,Signature,ANS,-
,,An,electronic,signature,based,upon,cryptographic,methods,of,originator,authentication,,computed,by,us
ing,a,set,of,rules,and,a,set,of,parameters,such,that,the,identity,of,the,signer,and,the,integrity,of,the,data,c
an,be,verified.,(21,CFR,,Sec.,11.3)
Electronic,Record,ANS,-
,,Any,combination,of,text,,graphics,,data,,audio,,pictorial,,or,other,information,representation,in,digital,for
m,that,is,created,,modified,,maintained,,archived,,retrieved,or,distributed,by,a,computer,system.,(21,CFR,
,Sec.,11.3)
Electronic,Signature,ANS,-
,,A,computer,data,compilation,of,any,symbol,or,series,of,symbols,executed,,adopted,,or,authorized,by,an,i
ndividual,to,be,legally,binding,equivalent,of,the,handwritten,signature.,(21,CFR,,Sec.,11.3)
Open,system,ANS,-
,,An,environment,in,which,system,access,is,not,controlled,by,persons,who,are,responsible,for,the,content,
of,the,electronic,records,that,are,on,the,system.,(21,CFR,,Sec.,11.3)
Clinical,Investigation,ANS,-
,,Any,experiment,that,involves,a,test,article,and,one,or,more,human,subjects,and,that,either,is,subject,to,r
equirements,for,prior,submission,to,the,Food,and,Drug,Administration,under,section,505(i),or,520(g),of,th
e,act,,or,is,not,subject,to,requirements,for,prior,submission,to,the,Food,and,Drug,Administration,under,th
ese,sections,of,the,Act,,but,the,results,of,which,are,intended,to,be,submitted,later,to,,or,held,for,inspectio
,n,by,,the,Food,and,Drug,Administration,as,part,of,an,application,for,a,research,or,marketing,permit.,(21,CF
R,,sec.,50.3)
Investigator,ANS,-
,,An,individual,who,actually,conducts,a,clinical,investigation,,i.e.,,under,whose,immediate,direction,the,tes
t,article,is,administered,or,dispensed,to,,or,used,involving,,a,subject,,or,,in,the,event,of,an,investigation,co
nducted,by,a,team,of,individuals,,is,the,responsible,leader,of,that,team.,(21,CFR,,sec.,50.3)
Sponsor,ANS,-
,,A,person,who,initiates,a,clinical,investigation,but,who,does,not,actually,conduct,the,investigation,,i.e.,,th
e,test,article,is,administered,or,dispensed,to,,or,used,involving,,a,subject,under,the,immediate,direction,o
f,another,individual.,A,person,other,than,the,individual,(e.g.,,corporation,or,agency),that,uses,one,or,mor
e,of,its,own,employees,to,conduct,a,clinical,investigation,it,has,initiated,it,has,initiated,is,considered,to,be,
a,sponsor,(not,a,sponsor-
investigator),,and,the,employees,are,considered,to,be,investigators.,(21,CFR,,sec.,50.3)
Sponsor-Investigator,ANS,-
,,An,individual,who,both,initiates,and,actually,conducts,,alone,or,with,others,,a,clinical,investigation,,i.e.,,u
nder,whose,immediate,direction,the,test,article,is,administered,or,dispensed,to,,or,used,involving,,a,subje
ct.,The,term,does,not,include,any,other,person,other,than,an,individual,,e.g.,corporation,or,agency.,(21,CF
R,,sec.,50.3)
Handwritten,Signature,ANS,-
,,The,scripted,name,or,legal,mark,of,an,individual,handwritten,by,that,individual.,(21,CFR,,Sec.,11.3)
Act,ANS,-,,The,Food,,Drug,and,Cosmetic,Act,,as,amended.
Human,Subject,ANS,-
,,An,individual,who,is,or,becomes,a,participant,in,research,,either,as,a,recipient,of,the,test,article,or,as,a,co
ntrol.,A,subject,may,be,either,a,healthy,human,or,a,patient.,(21,CFR,,sec.,50.3)
Institution,ANS,-
,,Any,public,or,private,entity,or,agency,(including,Federal,,State,or,other,agencies).,The,word,facility,as,use
d,in,section,520(g),of,the,Act,is,deemed,to,by,synonymous,with,the,term,institution,for,purposes,of,this,pa
rt.(21,CFR,,sec.,50.3)
, Institutional,Review,Board,(IRB),ANS,-
,,Any,board,,committee,,or,other,group,formally,designated,by,an,institution,to,review,biomedical,researc
h,involving,humans,as,subjects,,to,approve,the,initiation,of,and,conduct,periodic,review,of,such,research.,
The,term,has,the,same,meaning,as,the,phrase,institutional,review,committee,as,used,in,section,520(g),of,t
he,act.,(21,CFR,,sec.,50.3)
Test,Article,ANS,-
,,Any,food,or,drug,(including,a,biological,product,for,human,use),,medical,device,for,human,use,,human,fo
od,additive,,color,additive,,electronic,product,,or,any,other,article,subject,to,regulation,under,the,act,or,u
nder,sections,351,,and,354-360F,of,the,Public,Health,Services,Act.,(21,CFR,,sec.,50.3)
Minimal,Risk,ANS,-
,,Means,that,the,probability,and,magnitude,of,harm,or,discomfort,anticipated,in,the,research,are,no,great
er,in,an,of,themselves,than,those,ordinarily,encountered,in,daily,life,or,during,the,performance,of,routine,
physical,or,psychological,examinations,or,tests.,(21,CFR,,sec.,50.3)
Legally,Authorized,Representative,ANS,-
,,An,individual,or,judicial,or,other,body,authorized,under,applicable,law,to,consent,on,behalf,of,a,prospect
ive,subject,to,the,subject's,participation,in,the,procedures,involved.,(21,CFR,,sec.,50.3)
Family,Member,ANS,-
,,Any,one,of,the,following,legally,competent,persons:,spouse;,parents;,children,(including,adopted,childre
n);,brothers,,sisters,and,spouses,of,brothers,and,sisters;,and,any,individual,related,by,blood,or,affinity,wh
ose,close,association,with,the,subject,is,equivalent,of,a,family,relationship.,(21,CFR,,sec.,50.3)
Assent,ANS,-
,,A,child's,affirmative,agreement,to,participate,in,a,clinical,investigation.,Mere,failure,to,object,may,not,,a
bsent,affirmative,agreement,,be,construed,as,assent.,(21,CFR,,sec.,50.3)
Children,ANS,-
,,Persons,who,have,not,attained,the,legal,age,for,consent,to,treatment,or,procedures,involved,in,clinical,in
vestigations,,under,the,applicable,law,of,the,jurisdiction,in,which,the,clinical,investigation,will,be,conduct
ed.,(21,CFR,,sec.,50.3)
Parent,ANS,-,,A,child's,biological,or,adoptive,parent.,(21,CFR,,sec.,50.3)
