SOCRA Certification QUIZZES WITH
COMPLETE SOLUTIONS
Investigator,should,(qualifications/agreements),ANS,-,,Be,qualified,by,training/education,and,expertise,
Be,familiar,with,the,product,investigational
Be,aware,and,comply,with,GCP,and,regulatory,requirements,
Permit,auditing/monitoring
Delegate,authority,and,maintain,a,log
Be,responsible,for,the,training,of,the,staff
Nuremberg,Code,ANS,-,,(1947),Ten,guidelines,for,the,ethical,treatment,of,human,subjects,in,research,-
,Came,about,after,Nuremberg,trial,in,Germany,during,world,war,II
Legal,force,of,the,document,was,NOT,established,or,incorporated,directly,into,the,American,or,German,la
w
Nuremberg,Code,10,Ethical,Guidelines,ANS,-
,,1.,Voluntary,consent,of,the,human,subject,is,absolutely,essential.,
2.,The,experiment,should,be,such,as,to,productive,results,for,the,good,of,society,unprocuable,by,other,m
ethods,or,means,and,not,ransom,and,unnecessary,in,nature.
3.,The,experiment,should,be,so,designed,and,based,on,the,results,of,animal,experimentation,and,a,knowl
edge,of,the,natural,history,of,the,disease.
4.,The,experiment,should,be,so,conducted,as,to,avoid,all,unnecessary,physical,and,mental,suffering,and,in
jury.
5.,No,experiment,should,be,conducted,where,there,is,an,a,prior,reason,to,believe,that,death,or,disabling,i
njury,will,occur.
6.,The,degree,of,risk,to,be,taken,should,never,exceed,that,determined,by,the,humanitarian,importance,of,
the
problem,to,be,solved,by,the,experiment.
7.,Proper,preparations,should,be,made,and,adequate,facilities,provided,to,protect,the,experimental,subje
ct,against,even,remote,possibilities,of,injury,,disability,,or,death.
,8.,The,experiment,should,be,conducted,only,by,scientifically,qualified,persons.,The,highest,degree,of,skill,
and,care.
9.,During,the,course,of,the,experiment,the,human,subject,should,be,at,liberty,to,bring,the,experiment,to,
an,end.
10.,During,the,course,of,the,experiment,the,scientist,in,charge,must,be,prepared,to,terminate,the,experi
ment,at,any,stage.
Nuremberg,Code,-,Key,Principles,ANS,-,,1.,Voluntary,participation
2.,Informed,Consent
3.,Minimization,of,risk
The,Nuremberg,Code,and,the,Declaration,of,Helsinki,are,the,basis,for,the...,ANS,-
,,Code,of,Federal,Regulations,Title,45,Volume,46,which,are,regulations,issued,by,the,United,states,depart
ment,of,heath,and,human,services
Declaration,of,Helsinki,ANS,-
,,(1964),Is,a,set,of,ethical,principles,regarding,human,experimentation,developed,for,the,medical,commun
ity,by,the,WMA,(World,Medical,Association).
Declaration,is,addressed,primarily,to,physicians.
The,WMA,(World,Medical,Association),encourages,others,who,are,involved,in,medical,research,involving,
human,subjects,to,adopt,these,principles.,Not,legally,mandated
Declaration,of,Helsinki,Key,Principles,ANS,-,,1.,Well-being,of,subjects,takes,precedence
2.,Respect,for,persons
3.,Protection,of,subjects,heath,and,rights
5.,Special,protection,for,vulnerable,populations
Declaration,of,Helsinki,has,undergone..,ANS,-,,7,revisions,and,2,clarifications,-,first,in,Finland,in,June,1964
, Who,developed,the,Declaration,of,Helsinki,and,why,ANS,-,,The,World,Medical,Associated,(WMA),-
,as,a,statement,of,ethical,principals,for,medical,research,involving,human,subjects,,including,research,on,i
dentifiable,human,material,and,data
General,Principals,of,the,Declaration,of,Helsinki,ANS,-
,,1.,"the,health,of,my,patient,will,be,my,first,consideration"
2.,It,is,the,duty,of,the,clinician,to,promote,and,safeguard,the,health,,well-being,and,rights,of,patients
3.,Medical,progress,is,based,on,research,that,ultimately,must,include,studies,involving,human,subjects
4.,The,primary,purpose,of,medical,research,involving,human,subjects,is,to,understand,the,causes,,develo
pment,and,effects,of,diseases
5.,Medical,research,is,subject,to,ethical,standards,that,promote,and,ensure,respect,for,all,human,subjects
,and,protect,their,heath,and,rights
6.,While,the,primary,purpose,of,medical,research,is,to,generate,new,knowledge,,this,goal,can,never,take,
precedence,over,the,rights,and,interests,of,individual,research,subjects,
7.,It,is,the,duty,of,clinicians,who,are,involved,in,medical,research,to,protect,the,life,,health,,dignity,,integri
ty,,right,to,self-determination,,privacy,,and,confidentiality,of,personal,information,of,research,subjects,
8.,Physicians,must,consider,the,ethical,,legal,and,regulatory,norms,and,standards,for,research,involving,h
uman,subjects,in,their,own,countries,as,well,as,applicable,international,norms,and,standards
9.,Medical,research,must,be,conducted,in,a,manner,that,minimizes,possible,harm,to,the,environment
10.,Medical,research,involving,human,subjects,must,be,conducted,only,by,individuals,with,the,appropriat
e,ethics,and,and,scientific,education,,training,and,qualifications
11.,Groups,that,are,underrepresented,in,medical,research,should,be,provided,appropriate,access,to,parti
cipation,in,research
12.,Physicians,who,combine,medical,research,with,medical,care,should,involve,their,patients,in,research,
only,to,the,extent,that,is,justified,by,its,potential,preventative,,diagnostic,or,therapeutic,value,
13.,Appropriate,compensation,and,treatment,for,subjects,who,are,harmed,as,a,result,of,participating,in,r
esear
The,Belmont,Report,ANS,-,,April,18th,,1979
1.,Respect,for,persons-informed,consent,,protection,of,vulnerable,populations
2.,Beneficence-non,malfeasance
3.,Justice-fairness
COMPLETE SOLUTIONS
Investigator,should,(qualifications/agreements),ANS,-,,Be,qualified,by,training/education,and,expertise,
Be,familiar,with,the,product,investigational
Be,aware,and,comply,with,GCP,and,regulatory,requirements,
Permit,auditing/monitoring
Delegate,authority,and,maintain,a,log
Be,responsible,for,the,training,of,the,staff
Nuremberg,Code,ANS,-,,(1947),Ten,guidelines,for,the,ethical,treatment,of,human,subjects,in,research,-
,Came,about,after,Nuremberg,trial,in,Germany,during,world,war,II
Legal,force,of,the,document,was,NOT,established,or,incorporated,directly,into,the,American,or,German,la
w
Nuremberg,Code,10,Ethical,Guidelines,ANS,-
,,1.,Voluntary,consent,of,the,human,subject,is,absolutely,essential.,
2.,The,experiment,should,be,such,as,to,productive,results,for,the,good,of,society,unprocuable,by,other,m
ethods,or,means,and,not,ransom,and,unnecessary,in,nature.
3.,The,experiment,should,be,so,designed,and,based,on,the,results,of,animal,experimentation,and,a,knowl
edge,of,the,natural,history,of,the,disease.
4.,The,experiment,should,be,so,conducted,as,to,avoid,all,unnecessary,physical,and,mental,suffering,and,in
jury.
5.,No,experiment,should,be,conducted,where,there,is,an,a,prior,reason,to,believe,that,death,or,disabling,i
njury,will,occur.
6.,The,degree,of,risk,to,be,taken,should,never,exceed,that,determined,by,the,humanitarian,importance,of,
the
problem,to,be,solved,by,the,experiment.
7.,Proper,preparations,should,be,made,and,adequate,facilities,provided,to,protect,the,experimental,subje
ct,against,even,remote,possibilities,of,injury,,disability,,or,death.
,8.,The,experiment,should,be,conducted,only,by,scientifically,qualified,persons.,The,highest,degree,of,skill,
and,care.
9.,During,the,course,of,the,experiment,the,human,subject,should,be,at,liberty,to,bring,the,experiment,to,
an,end.
10.,During,the,course,of,the,experiment,the,scientist,in,charge,must,be,prepared,to,terminate,the,experi
ment,at,any,stage.
Nuremberg,Code,-,Key,Principles,ANS,-,,1.,Voluntary,participation
2.,Informed,Consent
3.,Minimization,of,risk
The,Nuremberg,Code,and,the,Declaration,of,Helsinki,are,the,basis,for,the...,ANS,-
,,Code,of,Federal,Regulations,Title,45,Volume,46,which,are,regulations,issued,by,the,United,states,depart
ment,of,heath,and,human,services
Declaration,of,Helsinki,ANS,-
,,(1964),Is,a,set,of,ethical,principles,regarding,human,experimentation,developed,for,the,medical,commun
ity,by,the,WMA,(World,Medical,Association).
Declaration,is,addressed,primarily,to,physicians.
The,WMA,(World,Medical,Association),encourages,others,who,are,involved,in,medical,research,involving,
human,subjects,to,adopt,these,principles.,Not,legally,mandated
Declaration,of,Helsinki,Key,Principles,ANS,-,,1.,Well-being,of,subjects,takes,precedence
2.,Respect,for,persons
3.,Protection,of,subjects,heath,and,rights
5.,Special,protection,for,vulnerable,populations
Declaration,of,Helsinki,has,undergone..,ANS,-,,7,revisions,and,2,clarifications,-,first,in,Finland,in,June,1964
, Who,developed,the,Declaration,of,Helsinki,and,why,ANS,-,,The,World,Medical,Associated,(WMA),-
,as,a,statement,of,ethical,principals,for,medical,research,involving,human,subjects,,including,research,on,i
dentifiable,human,material,and,data
General,Principals,of,the,Declaration,of,Helsinki,ANS,-
,,1.,"the,health,of,my,patient,will,be,my,first,consideration"
2.,It,is,the,duty,of,the,clinician,to,promote,and,safeguard,the,health,,well-being,and,rights,of,patients
3.,Medical,progress,is,based,on,research,that,ultimately,must,include,studies,involving,human,subjects
4.,The,primary,purpose,of,medical,research,involving,human,subjects,is,to,understand,the,causes,,develo
pment,and,effects,of,diseases
5.,Medical,research,is,subject,to,ethical,standards,that,promote,and,ensure,respect,for,all,human,subjects
,and,protect,their,heath,and,rights
6.,While,the,primary,purpose,of,medical,research,is,to,generate,new,knowledge,,this,goal,can,never,take,
precedence,over,the,rights,and,interests,of,individual,research,subjects,
7.,It,is,the,duty,of,clinicians,who,are,involved,in,medical,research,to,protect,the,life,,health,,dignity,,integri
ty,,right,to,self-determination,,privacy,,and,confidentiality,of,personal,information,of,research,subjects,
8.,Physicians,must,consider,the,ethical,,legal,and,regulatory,norms,and,standards,for,research,involving,h
uman,subjects,in,their,own,countries,as,well,as,applicable,international,norms,and,standards
9.,Medical,research,must,be,conducted,in,a,manner,that,minimizes,possible,harm,to,the,environment
10.,Medical,research,involving,human,subjects,must,be,conducted,only,by,individuals,with,the,appropriat
e,ethics,and,and,scientific,education,,training,and,qualifications
11.,Groups,that,are,underrepresented,in,medical,research,should,be,provided,appropriate,access,to,parti
cipation,in,research
12.,Physicians,who,combine,medical,research,with,medical,care,should,involve,their,patients,in,research,
only,to,the,extent,that,is,justified,by,its,potential,preventative,,diagnostic,or,therapeutic,value,
13.,Appropriate,compensation,and,treatment,for,subjects,who,are,harmed,as,a,result,of,participating,in,r
esear
The,Belmont,Report,ANS,-,,April,18th,,1979
1.,Respect,for,persons-informed,consent,,protection,of,vulnerable,populations
2.,Beneficence-non,malfeasance
3.,Justice-fairness
