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GCP Questions and Answers (Q&A)

Drsmita_singh
Answered: Feb 15, 2017
United States
Europe
Japan

3 Answers

1057 views
John Adney
Answered: Sep 06, 2017

The most important consideration to take when conducting clinical trials is the protection of trial subjects

3 Answers

703 views
VivyL
Answered: Aug 27, 2017

The correct answer should be 8: In ICH GCP E6 (R1), The chapter 8 is essential documents for the conduct of a clinical trial, chapter 6 is about protocol and protocol amendment (s).

4 Answers

412 views
D. Ronald, Writer
Answered: Oct 09, 2018
Before anything else, you should first understand what a TMF or a Trial Master File is. This is a set of important documents that will be referred to before the clinical trial will take place....Read More

1 Answer

368 views
Drsmita_singh
Answered: Feb 15, 2017
Investigators brochure is the compilation of Chemistry-chemical properties, physical properties ,pharmaceutical properties and formulationof the drug, Manufacturing details- tells about the details...Read More

6 Answers

364 views
A. Cook, English Professor
Answered: Jun 20, 2019
The correct answer to this question is A, 6. GCP stands for good clinical practice. It is a standard code of conduct which the International Council for Harmonisation of Technical Requirements...Read More

3 Answers

323 views
Figueise
Answered: Feb 24, 2017
Is a standard provided by ICH, that defines a set of standards, which governments can thenuse into regulations for clinical trials involving human subjects

6 Answers

264 views
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