Exam (elaborations)
SOCRA CCRP Reporting & Timelines (Q & A) 2024
- Course
- Institution
SOCRA CCRP Reporting & Timelines (Q & A) 2024
[Show more]
Content preview
SOCRA CCRP Reporting & Timelines (Q & A) 2024A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect Answer- 5, 15
IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation Answer- 3
Al IRB records need to be kept for ____ years follow completion of research Answer- 3
FDA will provide written determination within ____ days after FDA receives IND or IDE Answer- 30
If immediate use of test article is required (as determined by PI) where independent determination cannot be granted, a statement with exemption from but PI and independent clinician must be submitted to IRB within ___ working days after use of article Answer- 5
An institution or organizations decision to disband a registered IRB also must be reported to OHRP in writing within ___ days after permanent cessation of ORBs review of supported research (45cfr46.505) Answer- 30
For Fatal or life threatening Unexpected ADRs or adverse events regulatory agencies should be notified ____ but no later than ____ calendar days after first knowledge by sponsor, follow by a completed as possible report within ____ additional calendar days Answer- ASAP, 7, 8 (total 15 days)
IRB must renew registration every ___ years (45CFR46.505) Answer- 3
No more than _____ days after imposing a clinical hold on an IND will the division director provide sponsor a written explanation for the hold Answer- 30 days
If all investigators covered by an IND Regina on clinical hold for ______ or more, IND will be inactivated Answer- 1 year
A sponsor shall within _____ days of anniversary date the IND went into effect provide a brief report Answer- 60
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 or Stuvia-credit 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 EvaTee. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $9.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
75632 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now