Exam (elaborations)
CCRC Exam questions with verified answers
- Course
- Institution
CCRC Exam questions with verified answers
[Show more]
Content preview
CCRC ExamClinical Trial - correct answer ✔✔process of studying human subjects to assess the effect of a particular
intervention (Drug, biologic, device, procedure or behavior change) on a pre specified set of measurable
events.
Endpoint or Outcome - correct answer ✔✔Clinical event, measurable indicator, subject reported
response
Feasibility of a Study - correct answer ✔✔Assessment of resource needs, regulator requirements, and
potential level of risk of harm for human subjects participating in study
Necessary controls in Clinical trials - correct answer ✔✔Inclusion/ exclusion criteria(identify target),
randomization(avoid bias), Blinding(avoid observation bias), Primary and secondary endpoints(prove
hypothesis)
Current Good Manufacturing Practices - correct answer ✔✔cGMP
Food and Drug Administration (FDA) - correct answer ✔✔federal agency responsible for the regulation
and enforcement of drug evaluation and distribution policies
Investigational New Drug (IND) - correct answer ✔✔application to the FDA that contains all the animal
and cell testing data
Length of time a sponsor must wait before starting clinical trials after IND submission to FDA - correct
answer ✔✔30 calendar days
Non-significant Risk Devices - correct answer ✔✔Tongue depressor, adhesive bandages
Premarket Review - correct answer ✔✔FDA process to evaluate the safety and effectiveness of devices
that support or sustain human life, or which present a potential, unreasonable risk of illness or injury
,Investigational Device Exemption (IDE) - correct answer ✔✔Submission to FDA for significant risk device
before a clinical trial can begin, that allows the investigational device to be used to collect safety and
effectiveness data required to support Premarket Approval application (PMA)
Gold standard of Study Design - correct answer ✔✔Randomized, controlled, double-blind
Double-blind randomized trial - correct answer ✔✔Neither study staff, nor the subject know the
assignment until study is completed
Study Designs - correct answer ✔✔Randomized, controlled, double blind, Observational, Retrospective,
Historical
QA/QI - correct answer ✔✔uses retrospective data obtained through chart reviews to evaluate and
improve a process, program, or line of service.
phase 1 study - correct answer ✔✔Assess safety and tolerability of a study drug in mostly healthy
subjects
Phase 2 study - correct answer ✔✔Focuses on obtaining evidence of therapeutic efficacy indicating that
the molecule has the desired effect. Performed in subjects with specific condition targeted by
investigational product.
Phase 3 Study - correct answer ✔✔Uses information gathered from Phase 1 and 2 studies to determine
safety and effectiveness.
New Drug Application (NDA) - correct answer ✔✔Phase 1-3 clinical trials prove drug is effective and safe,
this application is submitted to the FDA.
Phase 4 Study - correct answer ✔✔FDA has approved a drug and it is commercially available, but may be
necessary to gather more information about product through controlled clinical trial, also known as a
post market trial.
, Study sponsor - correct answer ✔✔Initiator of clinical investigation, overseeing entire process, develops
regulatory strategies, funding source, and manages interactions with regulatory authorities.
Protocol - correct answer ✔✔Formal document containing details of the study design and all the
associated procedures to be followed during the course of the study. Deviations from this can risk
subject safety, damage integrity of trial data, and jeopardize regulatory approval of product.
Basic elements of a protocol - correct answer ✔✔Objectives, scientific background, Trial design,
Selection and enrollment of subjects, procedure and research events, management of AEs, Statistical
considerations, Data collection and recordkeeping, Quality control, assurance of safety of patients is
protected.
Principal Investigator (PI) - correct answer ✔✔The person who is primarily in charge of research on a
project that is sponsored or funded by an organization. Also responsible for all study conduct, including
protecting human subjects and ensuring the integrity of the data obtained during the course of the trial.
Statement of Investigator - correct answer ✔✔FDA 1572-Must be signed by all investigators participating
under the clinical trial under the IND. This is an agreement by the investigator to conduct the study in
compliance with FDA regulations
Sub-Investigator - correct answer ✔✔Assists the PI by performing delegated tasks that are outlined in
the protocol.
Study Monitor or CRA - correct answer ✔✔Typically employed by the sponsor or CRO and is responsible
for evaluating the overall conduct of the trial at a research site.
Institutional Review Board (IRB) - correct answer ✔✔committee of administrators, scientists, and
community members that reviews proposals for research involving human participants. Oversees the
ethical and scientific aspects of a study, with special focus on risk of harm vs benefit assessment for
participating subjects.
Clinical Trial Agreement (CTA) - correct answer ✔✔Legal contract between the clinical site, investigator
and sponsor. Regulatory, financial and ethical implications will be included.
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 $17.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
79373 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now