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GCP Questions and Answers (Q&A)

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 ,Nonclinical- and clinical Information

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

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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 high standards. The guidelines tell how to conduct clinical trials and define the role of the conductor.

Performing quality endurance tests is how people ensure the instructions are being followed. Despite its strict nature, it has been seen as less moral than other guidelines due to conflicts of interest and disclosures. And Like the United States, the Europen Union also has such a set of instructions.

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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 person is forced to participate in a trial especially if the person does not want to do so.

Some investigators and lawyers try to persuade people in order to improve their case or to prove that the case has been solved even if it hasn’t been solved yet. It is best that people will always know when to say no and if they are being forced to participate, they should report this soon.

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Requires inpatient hospitalization or prolongation of existing hospitalization

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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 who created this in the beginning.

This seems to be around ever since clinical practice has taken place. This used to be kept in various file cabinets but because of modern times, it can now be placed electronically in different computers and gadgets. A lot of countries support the use of TMF since this can make things clearer.

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