Documentation of Clinical Trial Monitoring: A practical guide compliant with Good Clinical Practice
Edyta Niebrzegowska
Feb 2019 · Troubador Publishing Ltd
5.0star
6 reviewsreport
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64
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About this ebook
This concise e-book provides clinicians as well as administrative personnel involved in clinical research with an understanding of documentation related to clinical trial monitoring activities at each stage of the study from planning and set up, through conduct and close-out.
It has been written by an experienced clinical research associate in accordance with ICH GCP (both E6 R1 and its updated E6 R2 version) as well as modern monitoring practices.
It includes complete templates of clinical trial monitoring plan, site initiation visit report, monitoring visit during trial conduct report as well as trial close-out visit report. Each comes with detailed description and instructions as well as rich examples based on a fictional clinical trial scenario to give the readers best understanding of different aspects of clinical trial monitoring.
This easy-to-use guide helps to learn how to write monitoring plans and reports from scratch as well as is a handy reference for experienced trial administrators.
It introduces the readers to clinical trial monitoring requirements as well as lists and conveniently summarises all types of clinical research monitoring documentation which can be found in Investigator and Trial Master File.
Created in a convenient electronic format, this book is an important resource for research and administrative staff including CRAs and trial managers as well as doctors, research nurses and other healthcare personnel.
It has been written by an experienced clinical research associate in accordance with ICH GCP (both E6 R1 and its updated E6 R2 version) as well as modern monitoring practices.
It includes complete templates of clinical trial monitoring plan, site initiation visit report, monitoring visit during trial conduct report as well as trial close-out visit report. Each comes with detailed description and instructions as well as rich examples based on a fictional clinical trial scenario to give the readers best understanding of different aspects of clinical trial monitoring.
This easy-to-use guide helps to learn how to write monitoring plans and reports from scratch as well as is a handy reference for experienced trial administrators.
It introduces the readers to clinical trial monitoring requirements as well as lists and conveniently summarises all types of clinical research monitoring documentation which can be found in Investigator and Trial Master File.
Created in a convenient electronic format, this book is an important resource for research and administrative staff including CRAs and trial managers as well as doctors, research nurses and other healthcare personnel.
Ratings and reviews
5.0
6 reviews
Dawid J.
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June 1, 2023
Easy to understand guide for all of those planning to work in a clinical trial monitoring field. Properly referenced with clinical research legislative acts such as ICH GCP and FDA. I highly recommend the book!
Cássio Martins
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August 11, 2020
Este livro é essencial para quem quer ou precisa se aprofundar em pesquisa clínica, ele mostra de forma simples e didática maneiras práticas de como abordar a problemática da pesquisa científica! Além do mais está repleto de exemplos práticos! Parabenizo a autora pela excelente obra! Super recomendo a obra!
Emmanuel COLIN
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July 5, 2023
Ce guide clair et bien structuré, conforme à la législation et ancré dans la pratique, constitue un ouvrage de référence pour toute personne concernée par le suivi des essais cliniques en recherche médicale.
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