CCRP SOCRA Focused on timelines Exam Review Questions and A Level Marking Scheme Latest 2024/2025
5 views 0 purchase
Module
CCRP SOCRA
Institution
CCRP SOCRA
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 u...
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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller KieranKent55. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for £9.33. You're not tied to anything after your purchase.
