SOCRA EXAM PREP QUESTIONS WITH
UPDATED ANSWERS.
Laws,,ANS,-,passed,by,national,legislative,bodies;,establish,authority,of,national,regulatory,body
Regulations,,ANS,-
,Passed,by,regulatory,authorities;,controls,how,medical,products,are,investigated,and,approved;,have,eff
ect,of,law
guidance,,ANS,-,"current,thinking",of,regulatory,bodies;,non-binding
ICH,,ANS,-
,Developed,to,keep,people,doing,things,the,same,way,across,the,world;,international,effort,to,harmonize,
the,technical,requirements,for,product,registration
SOPs,,ANS,-,developed,by,an,organization,(sponsor,,site,,CRO,,IRB)
Compliance,with,regulations,,ANS,-,goal,of,SOPs
organization,,ANS,-,SOPs,are,binding,only,for,this
European,Union,,Japan,,and,the,US,,ANS,-
,The,ICH,makes,recommendations,for,adoption,by,regulatory,authorities,in:
GCP,,ANS,-
,guidelines,developed,by,the,ICH,for,global,implementation,on,April,30,,1996;,developed,in,consideration,
of,the,current,practices,of,the,EU,,Japan,,US,as,well,as,Australia,,Canada,,the,Nordic,countries,,and,the,W
HO
GCP,Compliance,,ANS,-
,an,international,ethical,and,scientific,quality,standard,for,designing,,conducting,,recording,and,reporting,
,trials,that,involve,human,subjects;,provides,public,assurance,that,the,rights,,safety,and,well-
being,of,trial,subjects,are,protected,and,that,the,clinical,trial,data,are,credible
quality,(chemistry,manufacturing,and,control,data;,CMC),,ANS,-,ICH,Q
efficacy,,ANS,-,ICH,E
safety,,ANS,-,ICH,S
Multidisciplinary,,ANS,-,ICH,M
QESM,,ANS,-,4,series',of,the,ICH
ICH,E6,,ANS,-,guidance,for,industry;,GCP;,consolidated,guidance
ICH,E2A,,ANS,-,Clinical,Safety,Data,Management:,Definitions,and,Standards,for,Expedited,Reporting
CFR,and,FDA,,ANS,-,provide,guidance,for,compliance,in,the,US
CFR,Title,21,,ANS,-,focuses,on,conducting,clinical,research
21,CFR,11,,ANS,-,electronic,records,and,signatures
21,CFR,50,,ANS,-,informed,consent
21,CFR,54,,ANS,-,financial,disclosure
21,CFR,56,,ANS,-,IRBs
, 21,CFR,312,,ANS,-,Investigational,New,Drug,(IND),application
21,CFR,314,,ANS,-,New,Drug,Application,(NDA)
21,CFR,812,,ANS,-,Investigational,Device,Exemption,(IDE)
21,CFR,814,,ANS,-,Premarket,approval,for,Medical,Devices
45,CFR,46,,ANS,-,focuses,on,federal,research
21,CFR,50.27,,ANS,-,documentation,of,informed,consent
Phase,I,,ANS,-,bioavailability,,pharmacokinetics,,safety
Phase,II,,ANS,-,small,group,of,subjects,with,condition,of,interest
Phase,III,,ANS,-,more,experiments,,bigger,safety,profile
Drug,Development,,ANS,-
,identify,potential,new,compounds;,test,appropriate,laboratory,and,animal,models,to,assess,potential,acti
vity,in,humans;,screening,may,involve,thousands,of,molecules
dosage,development,,ANS,-
,manufacture,pure,,stable,drug,substance,(active,ingredient);,test,various,formulations,to,optimize,the,dr
ug,product;,stability,testing,in,packaging,planned,to,be,used,for,clinical,trials,and,marketed,product
Excipients,,ANS,-,inactive,substances,used,as,a,carrier,for,the,active,ingredients,of,a,medication
non/pre-clinical,activities,,ANS,-,drug,discovery,and,development,of,dosage
UPDATED ANSWERS.
Laws,,ANS,-,passed,by,national,legislative,bodies;,establish,authority,of,national,regulatory,body
Regulations,,ANS,-
,Passed,by,regulatory,authorities;,controls,how,medical,products,are,investigated,and,approved;,have,eff
ect,of,law
guidance,,ANS,-,"current,thinking",of,regulatory,bodies;,non-binding
ICH,,ANS,-
,Developed,to,keep,people,doing,things,the,same,way,across,the,world;,international,effort,to,harmonize,
the,technical,requirements,for,product,registration
SOPs,,ANS,-,developed,by,an,organization,(sponsor,,site,,CRO,,IRB)
Compliance,with,regulations,,ANS,-,goal,of,SOPs
organization,,ANS,-,SOPs,are,binding,only,for,this
European,Union,,Japan,,and,the,US,,ANS,-
,The,ICH,makes,recommendations,for,adoption,by,regulatory,authorities,in:
GCP,,ANS,-
,guidelines,developed,by,the,ICH,for,global,implementation,on,April,30,,1996;,developed,in,consideration,
of,the,current,practices,of,the,EU,,Japan,,US,as,well,as,Australia,,Canada,,the,Nordic,countries,,and,the,W
HO
GCP,Compliance,,ANS,-
,an,international,ethical,and,scientific,quality,standard,for,designing,,conducting,,recording,and,reporting,
,trials,that,involve,human,subjects;,provides,public,assurance,that,the,rights,,safety,and,well-
being,of,trial,subjects,are,protected,and,that,the,clinical,trial,data,are,credible
quality,(chemistry,manufacturing,and,control,data;,CMC),,ANS,-,ICH,Q
efficacy,,ANS,-,ICH,E
safety,,ANS,-,ICH,S
Multidisciplinary,,ANS,-,ICH,M
QESM,,ANS,-,4,series',of,the,ICH
ICH,E6,,ANS,-,guidance,for,industry;,GCP;,consolidated,guidance
ICH,E2A,,ANS,-,Clinical,Safety,Data,Management:,Definitions,and,Standards,for,Expedited,Reporting
CFR,and,FDA,,ANS,-,provide,guidance,for,compliance,in,the,US
CFR,Title,21,,ANS,-,focuses,on,conducting,clinical,research
21,CFR,11,,ANS,-,electronic,records,and,signatures
21,CFR,50,,ANS,-,informed,consent
21,CFR,54,,ANS,-,financial,disclosure
21,CFR,56,,ANS,-,IRBs
, 21,CFR,312,,ANS,-,Investigational,New,Drug,(IND),application
21,CFR,314,,ANS,-,New,Drug,Application,(NDA)
21,CFR,812,,ANS,-,Investigational,Device,Exemption,(IDE)
21,CFR,814,,ANS,-,Premarket,approval,for,Medical,Devices
45,CFR,46,,ANS,-,focuses,on,federal,research
21,CFR,50.27,,ANS,-,documentation,of,informed,consent
Phase,I,,ANS,-,bioavailability,,pharmacokinetics,,safety
Phase,II,,ANS,-,small,group,of,subjects,with,condition,of,interest
Phase,III,,ANS,-,more,experiments,,bigger,safety,profile
Drug,Development,,ANS,-
,identify,potential,new,compounds;,test,appropriate,laboratory,and,animal,models,to,assess,potential,acti
vity,in,humans;,screening,may,involve,thousands,of,molecules
dosage,development,,ANS,-
,manufacture,pure,,stable,drug,substance,(active,ingredient);,test,various,formulations,to,optimize,the,dr
ug,product;,stability,testing,in,packaging,planned,to,be,used,for,clinical,trials,and,marketed,product
Excipients,,ANS,-,inactive,substances,used,as,a,carrier,for,the,active,ingredients,of,a,medication
non/pre-clinical,activities,,ANS,-,drug,discovery,and,development,of,dosage
