CCRP SOCRA Focused on timelines Exam
Review Questions and A Level Marking
Scheme Latest 2024/2025
5 working days report to fda - correct answer notice of change
to the ide
5 working days report to fda, investigators and irbs - correct
answer termination of study after determination due to a uade
that presents an unreasonable risk
5 working days to sponsor - correct answer investigator to
notify sponsor regarding irb withdrawal of approval
5 working days to fda, other participating irbs and pis - correct
answer sponsor to notify all other irbs and pis that another irb
withdrew approval
5 working days to sponsor and irb - correct answer investigator
to report to sponsor and irb use of a device without informed
consent (emergency use)
5 working days to all participating irbs and pis - correct answer
sponsor to notify irbs and pis of withdrawal of fda approval
5 working days to fda - correct answer sponsor becoming aware
that a device used without consent (emergency use by pi)
,5 working days to fda about irbs opinion - correct answer irb to
notify fda if it determines the device sponsor had proposed
device as non-significant risk is a significant risk
5 working days to all irb's, pis and fda - correct answer sponsor
determines the drug presents a unreasonable and significant risk
to subjects
Termination shall occur not later than 5 working days after the
sponsor makes
This determination and not later than 15 working days after the
sponsor first received notice of the effect - correct answer
sponsor to report to fda, investigators and irbs once they
determines the drug is an unreasonable risk to subjects
7 calendar days to notify, then 8 additional days to submit report
- correct answer report fatal or life threatening unexpected
adverse drug reaction
10 working days to fda, all irbs and all pis - correct answer
sponsor conducts an evaluation of a unanticipated adverse
device effect and reports the results
Sponsor has 10 working days to request to fda - correct answer
request a regulatory hearing in response to fda ind termination
Sponsor has 15 calendar days to report to fda - correct answer
ind safety reports of potential serious risks
, Sponsor has 15 calendar days to report to fda - correct answer
if fda requests additional info/data of ind safety report, how many
days does sponsor have to report to fda?
Sponsor has 15 working days to report to fda and all irbs -
correct answer if sponsor determines that a unanticipated
adverse device effect presents an unreasonable risk, how many
days to report to fda and irbs?
15 working days to notify fda - correct answer if pi wants to use
a drugs as part of an expanded access emergency must notify fda
Sponsor has 15 working days to report to fda - correct answer
sponsor report serious unexpected adverse drug reactions to fda
5 working days from when they make determination; 15 working
days to determine uade has occurred from first notice - correct
answer sponsor to notify fda after it determines that a
unanticipated adverse device effect occurred
Sponsor has max of 15 working days to request additional
information - correct answer suspected serious adverse
drug(sad) reaction reported to fda sponsor response time
Sponsor has max of 15 working days to submit a ind safety
report - correct answer event not initially determined
reportable but is now determined to be a suspected sad
Review Questions and A Level Marking
Scheme Latest 2024/2025
5 working days report to fda - correct answer notice of change
to the ide
5 working days report to fda, investigators and irbs - correct
answer termination of study after determination due to a uade
that presents an unreasonable risk
5 working days to sponsor - correct answer investigator to
notify sponsor regarding irb withdrawal of approval
5 working days to fda, other participating irbs and pis - correct
answer sponsor to notify all other irbs and pis that another irb
withdrew approval
5 working days to sponsor and irb - correct answer investigator
to report to sponsor and irb use of a device without informed
consent (emergency use)
5 working days to all participating irbs and pis - correct answer
sponsor to notify irbs and pis of withdrawal of fda approval
5 working days to fda - correct answer sponsor becoming aware
that a device used without consent (emergency use by pi)
,5 working days to fda about irbs opinion - correct answer irb to
notify fda if it determines the device sponsor had proposed
device as non-significant risk is a significant risk
5 working days to all irb's, pis and fda - correct answer sponsor
determines the drug presents a unreasonable and significant risk
to subjects
Termination shall occur not later than 5 working days after the
sponsor makes
This determination and not later than 15 working days after the
sponsor first received notice of the effect - correct answer
sponsor to report to fda, investigators and irbs once they
determines the drug is an unreasonable risk to subjects
7 calendar days to notify, then 8 additional days to submit report
- correct answer report fatal or life threatening unexpected
adverse drug reaction
10 working days to fda, all irbs and all pis - correct answer
sponsor conducts an evaluation of a unanticipated adverse
device effect and reports the results
Sponsor has 10 working days to request to fda - correct answer
request a regulatory hearing in response to fda ind termination
Sponsor has 15 calendar days to report to fda - correct answer
ind safety reports of potential serious risks
, Sponsor has 15 calendar days to report to fda - correct answer
if fda requests additional info/data of ind safety report, how many
days does sponsor have to report to fda?
Sponsor has 15 working days to report to fda and all irbs -
correct answer if sponsor determines that a unanticipated
adverse device effect presents an unreasonable risk, how many
days to report to fda and irbs?
15 working days to notify fda - correct answer if pi wants to use
a drugs as part of an expanded access emergency must notify fda
Sponsor has 15 working days to report to fda - correct answer
sponsor report serious unexpected adverse drug reactions to fda
5 working days from when they make determination; 15 working
days to determine uade has occurred from first notice - correct
answer sponsor to notify fda after it determines that a
unanticipated adverse device effect occurred
Sponsor has max of 15 working days to request additional
information - correct answer suspected serious adverse
drug(sad) reaction reported to fda sponsor response time
Sponsor has max of 15 working days to submit a ind safety
report - correct answer event not initially determined
reportable but is now determined to be a suspected sad
