Examen
ACRP-CP Exam Review(Based On Declaration Of Helsinki) 89 Questions and Answers Rated 100% Correct!!
- Cours
- Établissement
ACRP-CP Exam Review(Based On Declaration Of Helsinki) 89 Questions and Answers Rated 100% Correct!!
[Montrer plus]
Vendeur
S'abonner
NurseSallyD
Avis reçus
Aperçu du contenu
ACRP-CP Exam Review(Based On Declaration OfHelsinki) 89 Questions and Answers Rated 100%
Correct!!
Adverse Drug Reaction (ADR) - -All noxious and unintended responses to a medicinal
product related to any dose (causal relationship is at least a reasonable possibility).
Regarding marketed medicinal products: a response to a drug which is noxious and
unintended and which occurs at doses normally used in man for prophylaxis, diagnosis,
or therapy of diseases or for modification of physiological function
-Adverse Event (AE) - -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 treatment. (ICH GCP E6 1.2)
-Audit - -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 and accurately reported according to the protocol,
sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the
applicable regulatory requirement(s).
-Audit Trail - -Documentation that allows reconstruction of the course of events.
-Blinding/Masking - -A procedure in which one or more parties to the trial are kept
unaware of the treatment assignment. Single-blinding usually refers to the subject(s)
being unaware, and double- blinding usually refers to the subject(s), investigator(s),
monitor, and, in some cases, data analyst(s) being unaware of the treatment
assignment(s). (ICH GCP E6 1.10)
, -Case Report Form (CRF) - -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.
-Clinical Trial/Study - -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 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.
-Clinical Trial/Study Report - -A written description of a trial/study of any therapeutic,
prophylactic or diagnostic agent conducted in human subjects, in which the clinical and
statistical description, presentations, and analysis are fully integrated into a single
report. (ICH GCP E6 1.13)
-Comparator (Product) - -An investigational or marketed product (i.e., active control),
or placebo, used as a reference in a clinical trial.
-Compliance (in relation to trials) - -Adherence to all the trial-related requirements,
Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
-Direct Access - -Permission to examine, analyze, verify, and reproduce any records
and reports that are important to evaluation of a clinical trial.
-Documentation - -All records, in any form (including, but not limited to, written,
electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms)
that describe or record the methods, conduct, and/or results of a trial, the factors
affecting a trial, and the actions taken.
-Essential Documents - -Documents which individually and collectively permit
evaluation of the conduct of a study and the quality of the data produced.
Les avantages d'acheter des résumés chez Stuvia:
Qualité garantie par les avis des clients
Les clients de Stuvia ont évalués plus de 700 000 résumés. C'est comme ça que vous savez que vous achetez les meilleurs documents.
L’achat facile et rapide
Vous pouvez payer rapidement avec iDeal, carte de crédit ou Stuvia-crédit pour les résumés. Il n'y a pas d'adhésion nécessaire.
Focus sur l’essentiel
Vos camarades écrivent eux-mêmes les notes d’étude, c’est pourquoi les documents sont toujours fiables et à jour. Cela garantit que vous arrivez rapidement au coeur du matériel.
Foire aux questions
Qu'est-ce que j'obtiens en achetant ce document ?
Vous obtenez un PDF, disponible immédiatement après votre achat. Le document acheté est accessible à tout moment, n'importe où et indéfiniment via votre profil.
Garantie de remboursement : comment ça marche ?
Notre garantie de satisfaction garantit que vous trouverez toujours un document d'étude qui vous convient. Vous remplissez un formulaire et notre équipe du service client s'occupe du reste.
Auprès de qui est-ce que j'achète ce résumé ?
Stuvia est une place de marché. Alors, vous n'achetez donc pas ce document chez nous, mais auprès du vendeur NurseSallyD. Stuvia facilite les paiements au vendeur.
Est-ce que j'aurai un abonnement?
Non, vous n'achetez ce résumé que pour €11,52. Vous n'êtes lié à rien après votre achat.
Peut-on faire confiance à Stuvia ?
4.6 étoiles sur Google & Trustpilot (+1000 avis)
78998 résumés ont été vendus ces 30 derniers jours
Fondée en 2010, la référence pour acheter des résumés depuis déjà 14 ans