Exam (elaborations)
CCRC flashcards GCP Quiz with answers
- Course
- Institution
CCRC flashcards GCP Quiz with answers
[Show more]
Content preview
CCRC flashcards GCP QuizDo advertising materials need to be approved of by the IRB/IEC prior to distribution - correct answer
✔✔Yes
Which documents must be submitted to the IRB/IEC prior to the trial? - correct answer ✔✔The protocol
and the investigators brochure
What are expected or possible consequences of over-estimation of recruitment potential? - correct
answer ✔✔1- Running over the projected timeline due to difficulties in recruiting.
2-Multiple sites may be needed to be added to help with recruiting.
3-The study may be stopped due to lack of budget and there won't be the expected data produced in the
timeline projected.
Which of the following should be the first consideration when conducting a clinical trial - correct answer
✔✔Subject safety/welfare
When is the investigator allowed to deviate from the protocol? - correct answer ✔✔When there is a
hazard to the patient or subject.
Which conditions should be fulfilled when enrolling a subject into your trial? - correct answer ✔✔Do
they meet inclusion criteria and have they provided written informed consent.
When there is a reconsent or change in the Informed consent document for a trial the CRC/site needs to:
- correct answer ✔✔Reconsent all subjects and make them aware of any changes to the protocol.
What does "therapeutic misconception" mean? - correct answer ✔✔The subjects, patients, or
volunteers aren't receiving medical treatment for their condition. The study is for research only.
Who has ultimate trial responsibility for the each subject? - correct answer ✔✔The principal investigator
(PI)
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 BravelRadon. 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)
78140 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now