Documentation of Clinical Trial Monitoring

A practical guide compliant with Good Clinical Practice

by Edyta Niebrzegowska

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.

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About the Author

Edyta Niebrzegowska

BSc, MSc, RD, CCRC

Clinical Research Methodologist

Edyta graduated from Queen Mary University of London with MSc in Healthcare Research Methods. Since 2009, she has acted as a professional clinical researcher in United Kingdom holding appointments of research coordinator at Bart's Health NHS Trust and local investigator at UK Perioperative Medicine Clinical Trials Network as well as honorary clinical research associate at Queen Mary University of London. Edyta has worked on more than 40 research projects so far, including early and late phase randomised controlled trials of medicines, medical devices, new therapeutic interventions and biomarkers as well as observational and epidemiological studies at their various stages including design and set up as well as conduct, monitoring and closure. The scope of her research work includes critical care, emergency, perioperative and renal medicine as well as major surgery, immunology and genetics. She also is an ACRP certified clinical research coordinator.