100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Practice Questions for SOCRA exam VERIFIED 2022/2023 $15.52   Add to cart

Exam (elaborations)

Practice Questions for SOCRA exam VERIFIED 2022/2023

 0 view  0 purchase

Practice Questions for SOCRA exam VERIFIED 2022/2023

Preview 2 out of 10  pages

  • June 21, 2023
  • 10
  • 2022/2023
  • Exam (elaborations)
  • Questions & answers
All documents for this subject (2)
avatar-seller
vickerthedon
Practice Questions for SOCRA exam
latest

Which of the following is a disclosure of financial interests form? correct answer



Which of the following is a certification of financial interest form? correct answer



If the investigator did have financial arrangement with the sponsor, he/she would submit the following
form: correct answer



This form is submitted by sponsor to the FDA prior to the beginning of the drug trial correct
answerInvestigational New Drug Application



In the top right corner, form have OMB number. What does it stand for? correct answer



The form, which is submitted to the FDA to report an Adverse Event is correct answer



Medical device adverse events/problems are reported via a form: correct answer



What is FDA form 1571? correct answer



21 CFR 312 deals with correct answer



Investigational new drug means correct answerA new drug or biological drug that is used in a clinical
investigation



The immediate package of an investigational new drug intended for human use shall bear a label wit the
statement correct answer

, Which of the following is not listed on FDA form 1571: correct answera. name, address, phone number
of the sponsor

b. a commitment not to start the clinical investifation until the InD is in effect

c. identification of the phase of the trail

d. approved informed consent document



"Any adverse drug experience that places the patient or subject, in the view of the investigator, at
immediate risk of death from the reaction as it occurred" Is... correct answera. serious adverse drug
experience

b. life threatening adverse drug experience

c. none of the above



What are the three main basic ethical principles of the Belmont Report? correct answer1. Respect for
Persons

2. Beneficence

3. Justice



What are the applications for the Belmont Report? correct answer1. Informed Consent

2. Assessment of Risk and Benefits

3. Selection of Subjects



What phrase of a drug trial usually includes hundreds to thousands of volunteers? correct answerPhase
3: These studies gather more information about safety and effectiveness, study different populations
and different dosages, and uses the drug in combination with other drugs.



What is a drug as defined by the FDA? correct answerA drug is an product that is intended for use in the
diagnosis, cure mitigation, treatment, or prevention of disease; and that is intended to affect the
structure or any function of the body.



What is Phase 1 of a clinical trial? correct answer20-80: Typical number of healthy volunteers used in
Phase 1: this phase emphasizes SAFETY.

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 vickerthedon. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for $15.52. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

81531 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
$15.52
  • (0)
  Add to cart