Good Scientific Practice (gsp) and Good Clinical Practice (gcp)
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The importance of Good Clinical Practice guidelines and its role in clinical trials
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. It also serves to protect the rights, integrity and confidentiality of trial subjects. It is very important to understand the background of the formation of the ICH-GCP guidelines as this, in it...
متن کاملForum: The need for Good Clinical Practice in health care research
Randomised controlled trials form the foundation for ‘evidence-based-medicine’, but the results of such research can be relied upon only if it was conducted according to principles and standards collectively referred to as ‘Good Clinical Practice’ (GCP). The GCP was established as a basis both for the scientific and ethical integrity of research involving human subjects and for generating valid...
متن کاملGood clinical practice: issues and challenges.
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials involving the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, integrity and confidentiality and well being of trial subjects are ...
متن کاملGood clinical practice: historical background and key aspects.
Clinical research trials (both academic and industry sponsored) are increasingly playing a role in various medical disciplines, including younger fields of clinical trial interest, such as nuclear medicine research. Knowledge for and compliance with good clinical practice (GCP) is essential for anyone involved. In this review article, key aspects of GCP and the responsibilities of investigators...
متن کاملGood clinical practice in clinical interventional studies
Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise 'frequently asked questions' format. While compliance to current rules and regulations is our mission, we also wish to play devil's advocate attempting to translate the rules into sizeable ...
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