Best GCP Questions and Answers (Q&A) - ProProfs Discuss

What are the 3 Geographical Regions involved in ICH?

Drsmita_singh
Answered: Feb 15, 2017

United States
Europe
Japan

3 Answers

1648 views

What is the most important consideration when conducting a clinical trial according to the principles of ICH GCP?

John Adney
Answered: Sep 06, 2017

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

3 Answers

1358 views

Which Chapter of ICH GCP is essential documents listed in?

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

771 views

What are some key elements included in the Investigators Brochure?

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

579 views

Who is responsible for creating the TMF (Trial Master File)?

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

566 views

What are GCP documents in Medical field?

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

428 views

Can you define GCP in your own words?

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

376 views

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