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GCP Questions and Answers (Q&A)

Explore hundreds of interesting GCP questions and answers (q & a).... Read More Become a part of the community, collaborate with the like-minded people from across the world, and share answers about GCP questions. You can also ask any question in case you do not find answers in our library or help someone by providing your best answer.
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, Control-Stability ,humidity ,storage ,purity etc...Read More

5 Answers

Is a standard provided by ICH, that defines a set of standards, which governments can thenuse into regulations for clinical trials involving human subjects

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United States

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

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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).

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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 for Pharmaceuticals for Human Us, abbreviated ICH, provides. GCP is strictly enforced, and they have...Read More

2 Answers

C is the answer to this question. It is important that people know their rights especially when it comes to the law. The laws, rules, and regulations are always changing. It can be complicated when you do not know what your rights are. What if people are already taking advantage of you? No...Read More

1 Answer

Requires inpatient hospitalization or prolongation of existing hospitalization

1 Answer

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. This can also be used for evaluation purposes. There is not enough information available that will say...Read More

1 Answer

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