Exam (elaborations)
CCRC(questions well answered)graded A+
- Course
- Institution
CCRC(questions well answered)graded A+
[Show more]
Content preview
CCRCAdverse Drug Reaction - correct answer ✔✔All noxious and unintended responses to a medicinal
product related to any dose should be considered an ADR.
Blinding - correct answer ✔✔A procedure in which one or more parties to the trial are kept unaware of
the treatment assignments.
Single Blind - correct answer ✔✔Refers to the subject being unaware of the treatment assignment
Double Blind - correct answer ✔✔Refers to the subject, investigator, monitor, and sometimes analyst
being unaware of the treatment.
Case Report Form (CRF) - correct answer ✔✔A printed, optical, or electronic document designed to
record all of the protocol required information to be reported to the sponsor on each trial subject.
Comparator - correct answer ✔✔An investigational or marketed product, or a placebo, used as reference
in a clinical trial.
Contract Research Organization - correct answer ✔✔A person or organization contracted by the sponsor
to preform one or more of a sponsor's trial-related duties and functions.
Good Clinical Practice (GCP) - correct answer ✔✔A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the
data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of
the trial subjects are protected.
Institutional Review Board - correct answer ✔✔An independent body constituted of medical, scientific,
and non-scientific members, whose responsibility is to ensure the protection of the rights, safety, and
well-being of human subjects involved in the trial.
, Investigational Product - correct answer ✔✔A pharmaceutical form of an active ingredient or placebo
being tested or used as reference in a clinical trial
Investigator's Brochure - correct answer ✔✔A compilation of the clinical and non-clinical data on the
investigational product(s) which is relevant to the study of the investigational product(s) in human
subjects.
Protocol - correct answer ✔✔A document that describes the objective(s), design, methodology,
statistical considerations, and organization of a trial.
Serious Adverse Event (SAE) - correct answer ✔✔Any untoward medical occurrence that at any dose:
-results in death,
-is life-threatening,
-requires inpatient hospitalization or prolongation
-results in persistent or significant disability/incapacity
Source data - correct answer ✔✔All information in original records and certified copies of original
records of clinical findings, observations, or other activities in a trial necessary for the reconstruction and
evaluation of the trial.
Sponsor - correct answer ✔✔An individual, company, institution, or organization which takes
responsibility for the initiation, management, and/or financing of a clinical trial.
Standard Operating Procedures (SOPs) - correct answer ✔✔Detailed, written instructions to achieve
uniformity of the performance of a specific function.
The purpose of an IRB is to: - correct answer ✔✔Protect the rights and welfare of human subjects of
research.
The investigator must obtain IRB approval of the study and the consent form: - correct answer
✔✔Before enrolling any patients in the study
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 $15.99. You're not tied to anything after your purchase.
Can Stuvia be trusted?
4.6 stars on Google & Trustpilot (+1000 reviews)
78252 documents were sold in the last 30 days
Founded in 2010, the go-to place to buy study notes for 14 years now