roles and responsibilities of CRCs Certification Review Exam Questions And Answers Accurately Solved.
3 views 0 purchase
Course
CRCB
Institution
CRCB
What is a clinical trial? - correct answer Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational products, and/or to study absorption, distribution, m...
What is a clinical trial? - correct answer Any investigation in human subjects
intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an
investigational products, and/or to study absorption, distribution, metabolism, and excretion of an
investigational products with the object of ascertaining its safety and/or efficacy. the terms clinical trial
and clinical study are synonymous
what is human research? - correct answer human research is research
involving human participants, who may participate through:
1) taking part in survey, interviews or focus groups
2) undergoing psychological, medical testing or treatment
3) being observed by researchers
4) researchers having access to their personal documents or other materials
5) the collection and use of their body organs, tissues or fluids (eg skin, blood,urine, saliva, bones, hair ,
other biopsy specimens)
6) Their information (in individually identifiable, re-identifiable or non-identifiable form) being assessed
as part of an existing published or unpublished source or database
general organizational chart for clinical trial - correct answer compenent
authorities (HSA) --> Sponsor
Sponsor -->
1)Clinical laboratory analysis
2) the investigator and study team members --> Subjects
3) ethics committee
sponsor-initiated trial - correct answer Sponsor (drug company ) --> CRA+ CTA
--> Clinical trial site ( hospitals, medical institutions)
CT team: Principal investigator, Investigators, Clinical research coordinator (CRC)
, investigator - initiated trials (IITs) - correct answer Clinical trial site( hospitals,
medical institutions) --> CT team: Pricinpal investigator, investigator and clinical research coordinator
(CRC)
Clinical Research Coordinator (CRC) - correct answer - a specialized research
professional, working with & under the direction of, the Clinical Investigator
- Handles the bulk of daily clinical trial activities
Clinical investigator - correct answer legally responsible for the management
of a clinical trial at a site
Background of CRCs - correct answer medical professionals: Nurses, physician
assistants,etc.
non-medical professionals: Science background, experience-based training
training of CRC - correct answer - on the job training by experienced CRCs
- sponsor companies: protocol or study specific
- investigator meetings: formal presentation and informal interaction
- Formal training courses : professional organization, universities and NYP
- Increasing trend of the overseas universities offering undergraduate and graduate degrees in clinical
research management
- Certification for CRCs has been very well accepted over the past several years.
personality and skills, CRC job is multi faceted, with a mixture of duties - correct answer
administrative, business, medical and patient oriented
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 RealGrades. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $13.99. You're not tied to anything after your purchase.
