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GCP Questions and Answers (Q&A)

Drsmita_singh
Answered: Feb 15, 2017
United States
Europe
Japan

3 Answers

559 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

315 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

314 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

289 views
Bergeront Tiffney, Computer Engineer
Answered: May 02, 2019
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...Read More

2 Answers

274 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

256 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

243 views
Angela
Answered: Apr 04, 2020
6

1 Answer

231 views
John Adney
Answered: Sep 07, 2017
Sec. 312.57 Recordkeeping and record retention. (a) A sponsor shall maintain adequate records showing the receipt, shipment, or other disposition of the investigational drug. These record...Read More

2 Answers

224 views
Sumalee_sp
Answered: Jan 25, 2017
Requires inpatient hospitalization or prolongation of existing hospitalization

2 Answers

220 views
John Smith
Answered: Apr 04, 2020
Subjects must sign the informed consent document prior to the conduct of study-specific procedures (that are not part of routine care)

1 Answer

217 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

214 views
John Smith
Answered: Apr 04, 2020
True

21 CFR 312.64(b) - An investigator shall promptly report to the sponsor any adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the...Read More

2 Answers

206 views
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