SOCRA CCRP REPORTING & TIMELINES
QUESTIONS WITH RIGHT ACTUAL
ANSWERS.
A,sponsor,who,determines,and,unanticipated,AE,presents,unreasonable,risk,,termination,shall,o
ccur,within,_____,working,days,and,not,later,than,___,working,days,after,sponsor,first,received,
notice,of,effect,,ANS,-,5,,15
IRB,determinations,for,emergency,situations,are,to,be,retained,by,IRB,for,at,least,___,years,after,
completion,of,clinical,investigation,,ANS,-,3
Al,IRB,records,need,to,be,kept,for,____,years,follow,completion,of,research,,ANS,-,3
FDA,will,provide,written,determination,within,____,days,after,FDA,receives,IND,or,IDE,,ANS,-,30
If,immediate,use,of,test,article,is,required,(as,determined,by,PI),where,independent,determinati
on,cannot,be,granted,,a,statement,with,exemption,from,but,PI,and,independent,clinician,must,b
e,submitted,to,IRB,within,___,working,days,after,use,of,article,,ANS,-,5
An,institution,or,organizations,decision,to,disband,a,registered,IRB,also,must,be,reported,to,OHR
P,in,writing,within,___,days,after,permanent,cessation,of,ORBs,review,of,supported,research,(45
cfr46.505),,ANS,-,30
For,Fatal,or,life,threatening,Unexpected,ADRs,or,adverse,events,regulatory,agencies,should,be,n
otified,____,but,no,later,than,____,calendar,days,after,first,knowledge,by,sponsor,,follow,by,a,co
mpleted,as,possible,report,within,____,additional,calendar,days,,ANS,-,ASAP,,7,,8,(total,15,days)
IRB,must,renew,registration,every,___,years,(45CFR46.505),,ANS,-,3
No,more,than,_____,days,after,imposing,a,clinical,hold,on,an,IND,will,the,division,director,provid
e,sponsor,a,written,explanation,for,the,hold,,ANS,-,30,days
If,all,investigators,covered,by,an,IND,Regina,on,clinical,hold,for,______,or,more,,IND,will,be,inacti
vated,,ANS,-,1,year
A,sponsor,shall,within,_____,days,of,anniversary,date,the,IND,went,into,effect,provide,a,brief,rep
ort,,ANS,-,60
Serious,unexpected,ADRs,that,are,not,fatal,or,life,threatening,must,be,filed,ASAP,but,no,later,tha
n,____,calendar,days,after,first,knowledge,by,sponsor,that,case,meets,criteria,,ANS,-,15
QUESTIONS WITH RIGHT ACTUAL
ANSWERS.
A,sponsor,who,determines,and,unanticipated,AE,presents,unreasonable,risk,,termination,shall,o
ccur,within,_____,working,days,and,not,later,than,___,working,days,after,sponsor,first,received,
notice,of,effect,,ANS,-,5,,15
IRB,determinations,for,emergency,situations,are,to,be,retained,by,IRB,for,at,least,___,years,after,
completion,of,clinical,investigation,,ANS,-,3
Al,IRB,records,need,to,be,kept,for,____,years,follow,completion,of,research,,ANS,-,3
FDA,will,provide,written,determination,within,____,days,after,FDA,receives,IND,or,IDE,,ANS,-,30
If,immediate,use,of,test,article,is,required,(as,determined,by,PI),where,independent,determinati
on,cannot,be,granted,,a,statement,with,exemption,from,but,PI,and,independent,clinician,must,b
e,submitted,to,IRB,within,___,working,days,after,use,of,article,,ANS,-,5
An,institution,or,organizations,decision,to,disband,a,registered,IRB,also,must,be,reported,to,OHR
P,in,writing,within,___,days,after,permanent,cessation,of,ORBs,review,of,supported,research,(45
cfr46.505),,ANS,-,30
For,Fatal,or,life,threatening,Unexpected,ADRs,or,adverse,events,regulatory,agencies,should,be,n
otified,____,but,no,later,than,____,calendar,days,after,first,knowledge,by,sponsor,,follow,by,a,co
mpleted,as,possible,report,within,____,additional,calendar,days,,ANS,-,ASAP,,7,,8,(total,15,days)
IRB,must,renew,registration,every,___,years,(45CFR46.505),,ANS,-,3
No,more,than,_____,days,after,imposing,a,clinical,hold,on,an,IND,will,the,division,director,provid
e,sponsor,a,written,explanation,for,the,hold,,ANS,-,30,days
If,all,investigators,covered,by,an,IND,Regina,on,clinical,hold,for,______,or,more,,IND,will,be,inacti
vated,,ANS,-,1,year
A,sponsor,shall,within,_____,days,of,anniversary,date,the,IND,went,into,effect,provide,a,brief,rep
ort,,ANS,-,60
Serious,unexpected,ADRs,that,are,not,fatal,or,life,threatening,must,be,filed,ASAP,but,no,later,tha
n,____,calendar,days,after,first,knowledge,by,sponsor,that,case,meets,criteria,,ANS,-,15
