Exam (elaborations)
MEGA SOCRA CCRP EXAM CONTENT Exam (Question and Answers) Review
- Course
- Institution
MEGA SOCRA CCRP EXAM CONTENT Exam (Question and Answers) Review
[Show more]
Seller
Follow
Content preview
MEGA SOCRA CCRP EXAM CONTENTExam (Question and Answers) Review
5 - correct answer The minimum number of IRB
members
Subjects cannot be enrolled until IRB/IEC approval has
been obtained - correct answer In a non-emergency
situation, under which of the following conditions, if any,
may subjects be enrolled into a study prior to IRB/IEC
approval?
The Sponsor - correct answer The responsibility for
ensuring that the investigator understands a clinical trial
lies with:
A subject has been enrolled on a study and was
randomized to the non-treatment arm. The protocol
outlines study procedures for all subjects to be performed
within one week of enrollment. Which of the following
statements about this case is correct? - correct answer
This subject should undergo all study procedures as
outlined in the protocol
A significant risk device is defined as an investigational
device that is: - correct answer a. Intended as an
,MEGA SOCRA CCRP EXAM CONTENT
Exam (Question and Answers) Review
implant and presents a potential for serious risk to the
health, safety, or welfare of a subject.
b. Purported or represented to be for a use in supporting
or sustaining human life and presents a potential risk to
the health, safety, or welfare of a subject.
c. For a use of substantial importance in diagnosing,
curing, mitigating, or treating disease, or otherwise
preventing impairment of human health and presents a
potential for serious risk to the health, safety, or welfare
of a subject.
With respect to IRB/IEC membership, both the FDA and
the ICH require that - correct answer At least one
member's primary area of interest is in a nonscientific
area
The rights, safety, and well-being of human subjects are
protected - correct answer A purpose of monitoring
clinical trials is to verify that:
,MEGA SOCRA CCRP EXAM CONTENT
Exam (Question and Answers) Review
Which of the following is the proper way to make a
correction to a CRF? - correct answer Add the initials of
the person making the change, the date of the change,
and, if necessary, a brief explanation of the change.
What details need to be documented in the subject
source documentation when an Adverse Event (AE)
occurs? Select all that apply - correct answer A. The
severity of the event
B. When the event occurred
C. Setting in which the event occurred
What is an Unexpected Adverse drug reaction? - correct
answer A reaction that is not consistent with the
applicable product information
The terms "serious" and "severe" are synonymous
according to ICH. - correct answer FALSE
A serious adverse event is any untoward medical
occurrence which at any dose is best described by which
of the following statements?
Select all that apply - correct answer A. Results in death
, MEGA SOCRA CCRP EXAM CONTENT
Exam (Question and Answers) Review
B. Is life-threatening
C. Is a congenital anomaly
. Which of the following options describes the term
"severe" in regards to ICH? - correct answer The
Intensity of a specific event
Subject 3826 had to stay in the hospital for three extra
days when his legs started swelling after participation in a
cardiac drug study. Swelling of the legs was listed in the
Investigator's Brochure as a possible side effect. Which of
the following options best describes this situation? -
correct answer Serious Adverse Drug Reaction
A subject in your diabetes research study developed
colon cancer, which the Investigator has determined to
be unrelated to the study. The subject is currently
asymptomatic. This will be considered a serious adverse
event because it is life threatening. Is this a true or false
statement? - correct answer FALSE
In pre-market approval studies, all noxious and
unintended responses to a medicinal product, even
possibly related to any dose, should be considered which
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 Ammelia. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $15.49. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
82215 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now