10/29/24, 7:08 AM 2024 Newest|ICH GCP for CCRC Exam Prep|2024-2025 UPDATE| COMPLETE FREQUENTLY TESTED QUESTIONS WITH…
2024 Newest|ICH GCP for CCRC Exam
Prep|2024-2025 UPDATE| COMPLETE
FREQUENTLY TESTED QUESTIONS WITH
VERIFIED ANSWERS|GET IT 100% ACCURATE!!
Terms in this set (543)
Adverse Drug Reaction All noxious and unintended responses to a
(ADR) medicinal product related to any dose
E6(R1) 1 Glossary of terms
Any untoward medical occurrence in a patient or
clinical investigation subject administered a
pharmaceutical product and which does not
necessarily have a causal relationship with this
Adverse Event (AE)
treatment--any unfavorable and unintended sign ,
symptom, or disease temporally associated with the
use of a medicinal product, whether or not related
to the medicinal product
Applicable Regulatory Any law(s) and regulation(s) addressing the conduct
Requirements of clinical trials of investigational products
The affirmative decision of the IRB that the clinical
trial has been reviewed and may be conducted at
Institutional Review
the institution site within the constraints set forth by
Board Approval
the IRB, the institution, Good Clinical Practice (GCP),
and the applicable regulatory requirements
, 10/29/24, 7:08 AM 2024 Newest|ICH GCP for CCRC Exam Prep|2024-2025 UPDATE| COMPLETE FREQUENTLY TESTED QUESTIONS WITH…
A systematic and independent examination of trial
related activities and documents to determine
whether the evaluated trial related activities were
conducted, and the data were recorded, analyzed
Audit
and accurately reported according to the protocol,
sponsor's standard operating procedures, (SOPs),
Good Clinical Practice (GCP), and the applicable
regulatory requirement(s)
A declaration of confirmation by the auditor that an
Audit Certificate
audit has taken place
A written evaluation by the sponsor's auditor of the
Audit Report
results of the audit
Documentation that allows reconstruction of the
Audit Trail
course of events
A procedure in which one or more parties to the
Blinding/Masking trial are kept unaware of the treatment
assignment(s).
A printed, optical, or electronic document designed
Case Report Form (CRF) to record all of the protocol required information to
be reported to the sponsor on each trial subject.
Any investigation in human subjects intended to
discover or verify the clinical, pharmacological
and/or other pharmacodynamic effects of an
investigational product(s), and/or to identify any
Clinical Trial/Study adverse reactions to an investigational product(s),
and/or to study absorption, distribution,
metabolism, and excretion of an investigational
product(s) with the object of ascertaining its safety
and/or efficacy
A written description of a trial/study of any
therapeutic, prophylactic, or diagnostic agent
Clinical Trial/Study
conducted in human subjects, in which the clinical
Report
and statistical description, presentations, and
analyses are fully integrated into a single report
An investigational or marketed product, or placebo,
Comparator (Product)
used as a reference in a clinical trial.
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 CodedNurse. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $0.00. You're not tied to anything after your purchase.
