100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
CCRA EXAM LATEST QUESTIONS AND ANSWERS $9.69   Add to cart

Exam (elaborations)

CCRA EXAM LATEST QUESTIONS AND ANSWERS

 1 view  0 purchase
  • Course
  • Institution

CCRA EXAM LATEST QUESTIONS AND ANSWERS What is 21 CFR 812? IDE What is 21 CFR 600? Biological Products What is 21 CFR 11? Electronic Records What is 21 CFR 50? Informed Consent What is ICH E6: 8 Essential Documents What is the purpose of maintaining study document and records? Insure ...

[Show more]

Preview 1 out of 1  pages

  • January 28, 2024
  • 1
  • 2023/2024
  • Exam (elaborations)
  • Questions & answers
avatar-seller
CCRA EXAM LATEST QUESTIONS AND ANSWERS
What is 21 CFR 812?
IDE
What is 21 CFR 600?
Biological Products
What is 21 CFR 11?
Electronic Records
What is 21 CFR 50?
Informed Consent
What is ICH E6: 8
Essential Documents
What is the purpose of maintaining study document and records?
Insure compliance; dealing with safety of patient, things have to be written down
What are source document?
First place data is written
What are case report forms?
Provides format for collecting protocol-required data
What is a Confidentiality Agreement?
Sponsor can protect information, don't want the researcher to disclose information
What is FDA 1572?
Legal contract between FDA and the investigator for investigational drug studies
What is the device equivalent of form FDA 1572?
Investigator Agreement or a Statement of Investigator
What law requires a CV for PI?
21 CFR 312; 21 CFR 812
What is the Financial Disclosure Certification (absense of financial interest) form?
Form 3454
What is the Financial Disclosure form for stating financial interest?
Form 3455
How long must the sponsor disclose financial interests?
One Year
How long must the sponsor maintain records after approval of the marketing
application?
2 years
Why is it important to have a Delagation of Authority Log?
Whoever is doing that specific treatment is trained; who is allowed to do what at each
site
Product safety information : adverse events, and is made available to each
investigator and routinely update. Which of the following regulatory documents
contains this information?
Investigator's Brochure

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

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

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

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 LectDan. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $9.69. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

81989 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 14 years now

Start selling
$9.69
  • (0)
  Add to cart