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ACRP - MDP Subspeciality

This class was created by Brainscape user Courtney Elliott. Visit their profile to learn more about the creator.

By: Courtney Elliott
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Decks in this class (13)

Declaration Of Helsinki (DOH)
When date and by whom was the dec...,
How often is the doh revised,
Why was the doh developed
36  cards
Abbreviation List
Adr,
Ae,
Alcoac
70  cards
ICH-E2A
Definition of an ae,
Can an abnormal lab finding be an ae,
Adr defintion for pre approval cl...
33  cards
ICH-E6A - General Defintions
What is gcp,
What is the objective of ich e6,
What is an audit trail
25  cards
ICH-E6A IRB/IEC
Clinical trials should be conduct...,
True or false before a trial is i...,
True or false clinical trials sho...
26  cards
ICH-E6 - Investigator, IRB/IEC and Sponsor
The investigator should be able t...,
The investigator should have suff...,
The investigator should have avai...
96  cards
ICH-E6A - Location of Essential Documents
Name the location and purpose of said essential documents
56  cards
ICH-E6A - Protocols and IB
What general information should b...,
What background information shoul...,
What should the trial object and ...
32  cards
ICH-E8
What type of study has the follow...,
Examples of human pharmacology st...,
What type of study has the follow...
42  cards
ICH-E9 - Statistical Principles
What does the term bias mean,
In ich e9 many of the principles ...,
The presence of bias may seriousl...
65  cards
ICH E9 Glossary
Bayesian approaches,
Bias statistical operational,
Blind review
27  cards
ICH E11 -CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION
True or falsedrug development pro...,
Whos responsibility is it to prot...,
Justification for the timing and ...
47  cards
ISO14155:2011
What does iso14155 overall address,
This international standard speci...,
True or falseiso does apply to in...
169  cards

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ACRP - MDP Subspeciality

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