Exam (elaborations)
ACRP CP FINAL EXAM LATEST 2024
- Course
- Institution
ACRP CP FINAL EXAM LATEST 2024
[Show more]
Content preview
ACRP CP FINAL EXAM LATEST 2024/2025 REALEXAM
1571 ` - ANSWER IND application; Permit to do research on humans for the first
time; has background info; and rationale; updated annually
1572 - ANSWER Investigator statement; commitment, done nationally and
internationally by sponsors intending to hava marketing aproval for IP
IB - ANSWER Clinical and non-clinical data on the investigational product that is
relevant to the study in human subjects; supplied prior to regulatory approval
Study type - Open Label - ANSWER everyone knows the treatment
Study type - Single blind - ANSWER one party knows Tx, usually the patient does
not know but the monitoring team does
Study type - Double Blind - ANSWER 2 or more people are blinded, usually the
patient and monitoring tram do not know which drug is given.
A 3rd party unblinded pharmacist is used and an unblinded CRA is needed
Study Type - Double dummy - ANSWER Use to blind similar Tx's; one is active and
one is placebo. This occurs when the drug and placebo cannot be made identical
(pill vs liquid)
Study Type - Parallel - ANSWER Two groups of treatments. One group receives
only treatment A and another group receives only treatment B
Study Type - Crossover - ANSWER Usually Chronic disease; receives more than
one Tx with a washout in between. A then B; could be randomized so the sequence
changes
Overall Survival - ANSWER the length of time from treatment until time of death. In
a clinical trial, measuring the overall survival is one way to see how well a new
treatment works.
Cohort - ANSWER Subjects are matched for similar groups; ex: Smokers, sex and
age
Study Type - Placebo control - ANSWER in addition to a group of subjects that
receives the treatment to be evaluated, a separate control group receives a placebo
Study Type - Active control - ANSWER Done when use of placebo is unethical like
antibiotics studies.
Means that a known, effective treatment (as opposed to a placebo) is compared to
an experimental treatment
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 leonardmuriithi061. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $17.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
81633 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now