GCP Quizzes & Trivia

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GCP Questions & Answers

Can you define GCP in your own words?
Is a standard provided by ICH, that defines a set of standards, which governments can thenuse into regulations for clinical trials involving human subjects
What are some key elements included in the Investigators Brochure?
Investigators brochure is the compilation of Chemistry-chemical properties, physical properties ,pharmaceutical properties and formulationof the drug, Manufacturing details- tells about the details whether drugs are manufactured as per as GMP, Contro
What is the most important consideration when conducting a clinical trial according to the principles of ICH GCP? 
The most important consideration to take when conducting clinical trials is the protection of trial subjects
Which chapter of ICH GCP is essential documents listed in?
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).