SOCRA EXAM QUESTIONS WITH
CORRECT ANSWERS.
Electronic,Records,,ANS,-
,Use,of,electronic,records,must,have,procedures,to,ensure,the,authenticity,,integrity,and,confidentiality,o
f,records.,Also,,the,procedures,must,ensure,the,signer,cannot,readily,repudiate,the,signed,records,a,snot,
genuine
Electronic,Records,-,Audit,Trail,,ANS,-,Electronic,records,must,use,secure,,computer,generated,,time-
stamped,audit,trails,to,independently,record,the,date,and,time,of,entries,and,actions,that,create,,modify,
or,delete,records.
Electronic,Records,-,Changes,,ANS,-,Record,changes,must,not,obscure,previously,recorded,information
Electronic,Records,-,Audit,Trail,Retention,,ANS,-
,Audit,trail,documentation,must,be,retained,for,a,period,at,least,as,long,as,that,required,for,the,subject,el
ectronic,records,and,must,be,available,for,agency,(FDA),review,and,copying.
Electronic,records,-,Controls,over,systems,documentation,,ANS,-
,1.,Controls,over,the,distribution,of,,access,to,,and,use,of,documentation,for,system,operation,and,mainte
nance
2.,Revision,and,change,control,procedures,to,maintain,an,audit,trail,that,documents,time-
sequenced,development,and,modification,of,systems,documentation
Electronic,records,-,Open,system,,ANS,-
,Procedures,and,controls,must,be,used,to,ensure,the,authenticity,,integrity,and,confidentiality,of,electron
ic,records,from,the,point,of,creation,to,the,point,of,receipt.
Examples:,Encryption,,Use,of,digital,signatures
Signed,Electronic,Records,,ANS,-
,Must,contain,information,associated,with,the,signing,that,clearly,indicate,all,of,the,following:
1.,Printed,name,of,signer
2.,Date,and,time,when,signature,was,executed
,3.,Meaning,(such,as,review,,approval,,responsibility,or,authorship),associated,with,signature
Electronic,Signature,Verification,,ANS,-
,Before,any,organization,establishes,,assigns,,certifies,or,otherwise,sanctions,an,individual's,electronic,sig
nature,,the,identity,of,the,individual,must,be,verified
Electronic,Signature,Certification,,ANS,-
,Prior,to,using,their,electronic,signature,,one,must,certify,to,the,agency,that,the,electronic,signatures,in,th
eir,system,,used,on,or,after,8/20/97,,are,intended,to,be,the,legally,binding,equivalent,of,traditional,hand
written,signatures
1.,Certification,must,be,submitted,in,paper,form,and,signed,with,a,traditional,handwritten,signature
2.,Upon,agency,request,,must,provide,additional,certification,or,testimony,that,a,specific,electronic,signat
ure,is,the,legally,binding,equivalent,of,the,handwritten,signature
Electronic,Signatures,not,based,on,biometrics,,ANS,-
,1.,Employ,at,least,2,distinct,identification,components,such,as,identification,code,and,password
a.,During,a,series,of,signings,over,a,continuous,period,of,controlled,system,access,,the,first,signing,uses,all
,electronic,signature,components,while,each,subsequent,signature,uses,at,least,1,electronic,signature,co
mponent,that,is,only,executable,by,the,individual
2.,Be,used,by,the,genuine,owners
3.,Administered,and,executed,to,ensure,that,attempted,use,of,an,electronic,signature,by,anyone,other,th
an,its,genuine,owner,requires,the,collaboration,of,2,or,more,individuals
Electronic,Signatures,based,on,biometrics,,ANS,-
,Designed,to,ensure,that,they,cannot,be,used,by,anyone,other,that,their,genuine,owners
Security,and,Integrity,of,identification,codes/passwords,,ANS,-
,1.,Maintain,uniqueness,of,each,combined,ID,code,and,password,(No,2,people,have,same,combo)
2.,ID,code,and,password,are,periodically,checked,,recalled,,revised,(Prevent,PW,aging)
3.,Loss,management,procedures,to,deauthorize,lost,,stolen,,missing,or,otherwise,compromised,devices,t
hat,generate,ID,code,or,PW,information,and,issue,replacements
4.,Use,of,safeguards,to,prevent,unauthorized,use,of,PWs,and/or,ID,codes,and,to,detect,and,report,any,att
empts,at,their,unauthorized,use
,5.,Initial,and,periodic,testing,of,devices,that,generate,ID,or,PW,information,to,ensure,they,function,proper
ly
General,Requirements,for,informed,consent,,ANS,-,Must,obtain,legally,effective,informed,consent
Must,allow,for,sufficient,opportunity,to,consider,whether,or,not,to,participate
Minimize,possibility,of,coercion,or,undue,influence
Must,use,language,understandable,by,participant
Informed,consent,-,Language,may,not,,ANS,-
,Language,may,not,include,exculpatory,language,in,which,the,subject,is,made,to,waive,or,appear,to,waive,
their,legal,rights,or,releases,or,appears,to,release,the,investigator,,the,sponsor,or,its,agents,from,liability,o
r,negligence
Exception-,Obtaining,informed,consent,,ANS,-
,Obtaining,informed,consent,is,deemed,feasible,unless,both,the,investigator,and,a,physician,who,is,not,no
t,participating,in,clinical,investigation,certify,in,writing,all,of,the,following:
1.,Subject,is,confronted,by,life-threatening,situation,necessitating,the,use,of,the,test,article
2.,Informed,consent,cannot,be,obtained,from,the,subject,because,of,an,inability,to,communicate,with,,or,
obtain,legally,effective,consent,from,,the,subject
3.,Time,is,not,sufficient,to,obtain,consent,from,the,subject's,legal,representative
4.,There,is,now,alternative,method,available,or,approved,or,generally,recognized,therapy,that,provides,a
n,equal,or,greater,likelihood,of,saving,the,life,of,the,subject
Immediate,use,of,the,test,article,,ANS,-
,If,immediate,use,is,required,,in,the,opinion,of,the,investigator,,to,preserve,the,life,of,the,subject,and,time
,is,not,sufficient,to,obtain,independent,determination,,the,determination,of,the,investigator,shall,be,mad
e,and,,within,5,working,days,of,the,use,of,the,article,,be,reviewed,and,evaluated,in,writing,by,a,physician,
who,is,not,participating,in,the,clinical,investigation
Documentation,for,exception,in,obtaining,informed,consent,,ANS,-
,Documentation,required,for,waiving,informed,consent,must,be,submitted,to,the,IRB,within,5,working,da
ys,after,the,use,of,the,test,article
, Waiver,of,consent,-,President,,ANS,-
,The,president,may,waive,prior,consent,for,the,administration,of,an,investigational,new,drug,to,a,member
,of,the,armed,forces,in,connection,with,the,member's,participation,in,a,particular,military,operation
The,president,must,determine,in,writing,that,obtaining,informed,consent,is,not,feasible,,is,contrary,to,the
,best,interests,of,the,military,member,,or,is,not,in,the,interest,of,national,security
Waiving,informed,consent,for,investigation,in,vitro,diagnostic,devices,used,to,identify,chemical,,biological
,,radiological,or,nuclear,agents,,ANS,-
,Before,use,of,the,test,article,,the,investigatory,and,uninvolved,physician,must,certify,in,writing:
1.,Subject,is,in,life-
threatening,situation,necessitating,the,use,of,the,product,to,identify,an,agent,that,would,suggest,a,terrori
sm,event,or,other,public,health,emergency
2.,Consent,cannot,be,obtained,because,the,person,collecting,the,specimen,could,not,know,there,would,b
e,a,need,to,use,the,product,on,that,specimen,and,time,is,not,sufficient,to,obtain,consent,without,risking,t
he,subject's,life
3.,Time,is,not,sufficient,to,obtain,consent,from,LAR
4.,No,available,alternative,method,of,diagnosis
Waiving,informed,consent,for,investigation,in,vitro,diagnostic,devices,used,to,identify,chemical,,biological
,,radiological,or,nuclear,agents,,ANS,-
,Before,use,of,the,test,article,,the,investigatory,and,uninvolved,physician,must,certify,in,writing:
1.,Subject,is,in,life-
threatening,situation,necessitating,the,use,of,the,product,to,identify,an,agent,that,would,suggest,a,terrori
sm,event,or,other,public,health,emergency
2.,Consent,cannot,be,obtained,because,the,person,collecting,the,specimen,could,know,there,would,be,a,n
eed,to,use,the,product,on,that,specimen,and,time,is,not,sufficient,to,botain,consent,without,risking,the,su
bject's,life
3.,Time,is,not,sufficient,to,obtain,consent,from,LAR
4.,No,available,alternative,method,of,diagnosis
Waiving,informed,consent,for,use,of,in-
vitro,diagnostic,device,and,not,sufficient,time,to,obtain,independent,determination,,ANS,-
,Before,using,the,device,,the,investigator,must,make,the,determination,and,it,must,be,reviewed,within,5,
working,days,by,uninvolved,physician
CORRECT ANSWERS.
Electronic,Records,,ANS,-
,Use,of,electronic,records,must,have,procedures,to,ensure,the,authenticity,,integrity,and,confidentiality,o
f,records.,Also,,the,procedures,must,ensure,the,signer,cannot,readily,repudiate,the,signed,records,a,snot,
genuine
Electronic,Records,-,Audit,Trail,,ANS,-,Electronic,records,must,use,secure,,computer,generated,,time-
stamped,audit,trails,to,independently,record,the,date,and,time,of,entries,and,actions,that,create,,modify,
or,delete,records.
Electronic,Records,-,Changes,,ANS,-,Record,changes,must,not,obscure,previously,recorded,information
Electronic,Records,-,Audit,Trail,Retention,,ANS,-
,Audit,trail,documentation,must,be,retained,for,a,period,at,least,as,long,as,that,required,for,the,subject,el
ectronic,records,and,must,be,available,for,agency,(FDA),review,and,copying.
Electronic,records,-,Controls,over,systems,documentation,,ANS,-
,1.,Controls,over,the,distribution,of,,access,to,,and,use,of,documentation,for,system,operation,and,mainte
nance
2.,Revision,and,change,control,procedures,to,maintain,an,audit,trail,that,documents,time-
sequenced,development,and,modification,of,systems,documentation
Electronic,records,-,Open,system,,ANS,-
,Procedures,and,controls,must,be,used,to,ensure,the,authenticity,,integrity,and,confidentiality,of,electron
ic,records,from,the,point,of,creation,to,the,point,of,receipt.
Examples:,Encryption,,Use,of,digital,signatures
Signed,Electronic,Records,,ANS,-
,Must,contain,information,associated,with,the,signing,that,clearly,indicate,all,of,the,following:
1.,Printed,name,of,signer
2.,Date,and,time,when,signature,was,executed
,3.,Meaning,(such,as,review,,approval,,responsibility,or,authorship),associated,with,signature
Electronic,Signature,Verification,,ANS,-
,Before,any,organization,establishes,,assigns,,certifies,or,otherwise,sanctions,an,individual's,electronic,sig
nature,,the,identity,of,the,individual,must,be,verified
Electronic,Signature,Certification,,ANS,-
,Prior,to,using,their,electronic,signature,,one,must,certify,to,the,agency,that,the,electronic,signatures,in,th
eir,system,,used,on,or,after,8/20/97,,are,intended,to,be,the,legally,binding,equivalent,of,traditional,hand
written,signatures
1.,Certification,must,be,submitted,in,paper,form,and,signed,with,a,traditional,handwritten,signature
2.,Upon,agency,request,,must,provide,additional,certification,or,testimony,that,a,specific,electronic,signat
ure,is,the,legally,binding,equivalent,of,the,handwritten,signature
Electronic,Signatures,not,based,on,biometrics,,ANS,-
,1.,Employ,at,least,2,distinct,identification,components,such,as,identification,code,and,password
a.,During,a,series,of,signings,over,a,continuous,period,of,controlled,system,access,,the,first,signing,uses,all
,electronic,signature,components,while,each,subsequent,signature,uses,at,least,1,electronic,signature,co
mponent,that,is,only,executable,by,the,individual
2.,Be,used,by,the,genuine,owners
3.,Administered,and,executed,to,ensure,that,attempted,use,of,an,electronic,signature,by,anyone,other,th
an,its,genuine,owner,requires,the,collaboration,of,2,or,more,individuals
Electronic,Signatures,based,on,biometrics,,ANS,-
,Designed,to,ensure,that,they,cannot,be,used,by,anyone,other,that,their,genuine,owners
Security,and,Integrity,of,identification,codes/passwords,,ANS,-
,1.,Maintain,uniqueness,of,each,combined,ID,code,and,password,(No,2,people,have,same,combo)
2.,ID,code,and,password,are,periodically,checked,,recalled,,revised,(Prevent,PW,aging)
3.,Loss,management,procedures,to,deauthorize,lost,,stolen,,missing,or,otherwise,compromised,devices,t
hat,generate,ID,code,or,PW,information,and,issue,replacements
4.,Use,of,safeguards,to,prevent,unauthorized,use,of,PWs,and/or,ID,codes,and,to,detect,and,report,any,att
empts,at,their,unauthorized,use
,5.,Initial,and,periodic,testing,of,devices,that,generate,ID,or,PW,information,to,ensure,they,function,proper
ly
General,Requirements,for,informed,consent,,ANS,-,Must,obtain,legally,effective,informed,consent
Must,allow,for,sufficient,opportunity,to,consider,whether,or,not,to,participate
Minimize,possibility,of,coercion,or,undue,influence
Must,use,language,understandable,by,participant
Informed,consent,-,Language,may,not,,ANS,-
,Language,may,not,include,exculpatory,language,in,which,the,subject,is,made,to,waive,or,appear,to,waive,
their,legal,rights,or,releases,or,appears,to,release,the,investigator,,the,sponsor,or,its,agents,from,liability,o
r,negligence
Exception-,Obtaining,informed,consent,,ANS,-
,Obtaining,informed,consent,is,deemed,feasible,unless,both,the,investigator,and,a,physician,who,is,not,no
t,participating,in,clinical,investigation,certify,in,writing,all,of,the,following:
1.,Subject,is,confronted,by,life-threatening,situation,necessitating,the,use,of,the,test,article
2.,Informed,consent,cannot,be,obtained,from,the,subject,because,of,an,inability,to,communicate,with,,or,
obtain,legally,effective,consent,from,,the,subject
3.,Time,is,not,sufficient,to,obtain,consent,from,the,subject's,legal,representative
4.,There,is,now,alternative,method,available,or,approved,or,generally,recognized,therapy,that,provides,a
n,equal,or,greater,likelihood,of,saving,the,life,of,the,subject
Immediate,use,of,the,test,article,,ANS,-
,If,immediate,use,is,required,,in,the,opinion,of,the,investigator,,to,preserve,the,life,of,the,subject,and,time
,is,not,sufficient,to,obtain,independent,determination,,the,determination,of,the,investigator,shall,be,mad
e,and,,within,5,working,days,of,the,use,of,the,article,,be,reviewed,and,evaluated,in,writing,by,a,physician,
who,is,not,participating,in,the,clinical,investigation
Documentation,for,exception,in,obtaining,informed,consent,,ANS,-
,Documentation,required,for,waiving,informed,consent,must,be,submitted,to,the,IRB,within,5,working,da
ys,after,the,use,of,the,test,article
, Waiver,of,consent,-,President,,ANS,-
,The,president,may,waive,prior,consent,for,the,administration,of,an,investigational,new,drug,to,a,member
,of,the,armed,forces,in,connection,with,the,member's,participation,in,a,particular,military,operation
The,president,must,determine,in,writing,that,obtaining,informed,consent,is,not,feasible,,is,contrary,to,the
,best,interests,of,the,military,member,,or,is,not,in,the,interest,of,national,security
Waiving,informed,consent,for,investigation,in,vitro,diagnostic,devices,used,to,identify,chemical,,biological
,,radiological,or,nuclear,agents,,ANS,-
,Before,use,of,the,test,article,,the,investigatory,and,uninvolved,physician,must,certify,in,writing:
1.,Subject,is,in,life-
threatening,situation,necessitating,the,use,of,the,product,to,identify,an,agent,that,would,suggest,a,terrori
sm,event,or,other,public,health,emergency
2.,Consent,cannot,be,obtained,because,the,person,collecting,the,specimen,could,not,know,there,would,b
e,a,need,to,use,the,product,on,that,specimen,and,time,is,not,sufficient,to,obtain,consent,without,risking,t
he,subject's,life
3.,Time,is,not,sufficient,to,obtain,consent,from,LAR
4.,No,available,alternative,method,of,diagnosis
Waiving,informed,consent,for,investigation,in,vitro,diagnostic,devices,used,to,identify,chemical,,biological
,,radiological,or,nuclear,agents,,ANS,-
,Before,use,of,the,test,article,,the,investigatory,and,uninvolved,physician,must,certify,in,writing:
1.,Subject,is,in,life-
threatening,situation,necessitating,the,use,of,the,product,to,identify,an,agent,that,would,suggest,a,terrori
sm,event,or,other,public,health,emergency
2.,Consent,cannot,be,obtained,because,the,person,collecting,the,specimen,could,know,there,would,be,a,n
eed,to,use,the,product,on,that,specimen,and,time,is,not,sufficient,to,botain,consent,without,risking,the,su
bject's,life
3.,Time,is,not,sufficient,to,obtain,consent,from,LAR
4.,No,available,alternative,method,of,diagnosis
Waiving,informed,consent,for,use,of,in-
vitro,diagnostic,device,and,not,sufficient,time,to,obtain,independent,determination,,ANS,-
,Before,using,the,device,,the,investigator,must,make,the,determination,and,it,must,be,reviewed,within,5,
working,days,by,uninvolved,physician
