Exam (elaborations)

2024 SOCRA CCRP REPORTING TIMELINES QUESTIONS AND CORRECT VERIFIED ANSWERS

Rating

Sold

Pages

Grade

A+

Uploaded on

11-04-2026

Written in

2025/2026

2024 SOCRA CCRP REPORTING TIMELINES QUESTIONS AND CORRECT VERIFIED ANSWERS

Institution

CCRP

Course

CCRP

Content preview

2024 SOCRA CCRP REPORTING
TIMELINES QUESTIONS AND CORRECT
VERIFIED ANSWERS
21A2CFRA2PartA250

IfA2immediateA2useA2ofA2aA2testA2articleA2isA2warrantedA2(byA2theA2PI),A2withinA2whatA2timef
rameA2mustA2theA2determinationA2ofA2theA2investigatorA2beA2reviewedA2byA2anA2outsideA2p
hysician?A2-A2Ans--WithinA25A2workingA2daysA2afterA2theA2useA2ofA2theA2testA2article

21A2CFRA2PartA250

IfA2immediateA2useA2ofA2aA2testA2articleA2occurs,A2whenA2mustA2theA2investigatorA2notifyA2t
heA2IRB?A2-A2Ans--WithinA25A2workingA2daysA2afterA2useA2ofA2theA2testA2article

21A2CFRA2PartA250

DocumentsA2relatedA2toA2exceptionA2fromA2informedA2consentA2requirementsA2forA2emerg
encyA2researchA2mustA2beA2maintainedA2byA2theA2IRBA2forA2howA2long?A2-A2Ans--
3A2yearsA2afterA2completionA2ofA2theA2investigation

21A2CFRA2PartA256

HowA2oftenA2mustA2IRBsA2renewA2theirA2registration?A2-A2Ans--EveryA23A2years

21A2CFRA2PartA256

IfA2anA2IRB'sA2contactA2orA2chairpersonA2informationA2changes,A2whenA2mustA2thisA2infor
mationA2beA2submittedA2toA2theA2FDA?A2-A2Ans--WithinA290A2daysA2ofA2theA2change

21A2CFRA2PartA256

IfA2anA2IRBA2decidesA2toA2reviewA2newA2typesA2ofA2FDA-
regulatedA2productsA2orA2toA2discontinueA2reviewingA2investigationsA2regulatedA2byA2theA2
FDA,A2whenA2mustA2thisA2changeA2beA2reported?A2-A2Ans--
WithinA230A2daysA2ofA2theA2change

21A2CFRA2PartA256

IfA2anA2IRBA2decidesA2toA2disband,A2whenA2mustA2thisA2changeA2beA2reported?A2-A2Ans--
WithinA230A2daysA2ofA2theA2change

21A2CFRA2PartA256

, HowA2oftenA2mustA2theA2IRBA2conductA2continuingA2reviewA2ofA2research?A2-A2Ans--
AtA2leastA2annually

21A2CFRA2PartA256

RecordsA2ofA2anA2IRBA2mustA2beA2maintainedA2forA2howA2long?A2-A2Ans--
3A2yearsA2afterA2theA2completionA2ofA2theA2investigation

21A2CFRA2PartA2312

HowA2longA2canA2theA2sponsorA2chargeA2forA2theA2drugA2inA2aA2clinicalA2trial?A2-A2Ans--
ForA2theA2lengthA2ofA2theA2clinicalA2trial

21A2CFRA2PartA2312

HowA2longA2canA2chargingA2forA2expandedA2accessA2toA2anA2investigationalA2drugA2forA2tr
eatmentA2useA2continue?A2-A2Ans--1A2yearA2fromA2theA2timeA2ofA2FDAA2authorization

21A2CFRA2PartA2312

WhenA2willA2theA2FDAA2provideA2aA2writtenA2determinationA2regardingA2theA2INDA2forA2anA
2investigationA2involvingA2anA2exceptionA2fromA2informedA2consent?A2-A2Ans--
30A2daysA2afterA2theA2FDAA2receivesA2theA2IND

21A2CFRA2PartA2312

WhenA2mustA2theA2sponsorA2notifyA2theA2FDAA2ofA2aA2newA2investigatorA2beingA2addedA2t
oA2theA2IND?A2-A2Ans--WithinA230A2daysA2ofA2theA2investigatorA2beingA2added

21A2CFRA2PartA2312

ProtocolA2amendmentsA2toA2addA2newA2investigatorsA2orA2toA2provideA2additionalA2inform
ationA2aboutA2investigatorsA2canA2beA2submittedA2atA2____-dayA2intervals?A2-A2Ans--30

21A2CFRA2PartA2312

InformationA2amendmentsA2toA2theA2INDA2shouldA2NOTA2beA2submittedA2moreA2thanA2eve
ryA2____A2days?A2-A2Ans--30

21A2CFRA2PartA2312

WhenA2mustA2theA2sponsorA2notifyA2theA2FDAA2andA2investigatorsA2ofA2anyA2potentialA2ser
iousA2risksA2(e.g.,A2SUSARs)A2-A2Ans--
NoA2laterA2thanA215A2calendarA2daysA2afterA2theA2sponsorA2determinesA2thatA2theA2inform
ationA2qualifiesA2forA2reporting

Report Copyright Violation

Written for

Institution: CCRP
Course: CCRP

Document information

Uploaded on: April 11, 2026
Number of pages: 8
Written in: 2025/2026
Type: Exam (elaborations)
Contains: Questions & answers

Subjects

2024 socra ccrp reporting timelines questions and

$12.49

Get access to the full document:

Written by students who passed

Immediately available after payment

Read online or as PDF

Get to know the seller

LECTUREKIM

1.0

(2)

Get to know the seller

LECTUREKIM stuvia

View profile

Sold

Member since

6 months

Number of followers

Documents

3423

Last sold

1 week ago

1.0

2 reviews

Why students choose Stuvia

Created by fellow students, verified by reviews

Quality you can trust: written by students who passed their tests and reviewed by others who've used these notes.

Didn't get what you expected? Choose another document

No worries! You can instantly pick a different document that better fits what you're looking for.

Pay as you like, start learning right away

No subscription, no commitments. Pay the way you're used to via credit card and download your PDF document instantly.

“Bought, downloaded, and aced it. It really can be that simple.”

Alisha Student

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 LECTUREKIM. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $12.49. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews) 49593 documents were sold in the last 30 days Founded in 2010, the go-to place to buy study notes for 16 years now

2024 SOCRA CCRP REPORTING TIMELINES QUESTIONS AND CORRECT VERIFIED ANSWERS

Content preview

Written for

Document information

Subjects

Get to know the seller

Recently viewed by you

Why students choose Stuvia

Created by fellow students, verified by reviews

Didn't get what you expected? Choose another document

Pay as you like, start learning right away

Working on your references?

Frequently asked questions

What do I get when I buy this document?

Satisfaction guarantee: how does it work?

Who am I buying these notes from?

Will I be stuck with a subscription?

Can Stuvia be trusted?