Mini-course Starter Kit – Data Monitoring Committees

Last update: 12 December 2016

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Introduction

This EUPATI Mini-course starter kit is designed for patient involvement in data monitoring committees.

EUPATI Mini-course starter kits have been derived from content found in the EUPATI toolbox and EUPATI Patient Expert Training Course. The starter kits are thought to address roles that patients play in medicines development for example those shown in the figure below.

The starter kits provide you with links to relevant background reading in the toolbox and associated PowerPoint slide decks and media in order to prepare a single or multi-day training on the subject. Each of the starter kits contains a selection of PPT slides which you may use to educate patients/advocates about the “basics” in that area, e.g. in a two-hour to one-day seminar.

The starter kits are based on existing content from the EUPATI Toolbox, plus additional links to add-on Toolbox material. None of the “starter kits” are “ready-made course” modules – they are a ready-to-reuse resource for an experienced trainer to prepare and execute a course. You will need to edit them and put them into context.

Before you begin please download and review the ‘Manual for Trainers’: A manual for trainers describing how to use the EUPATI mini-course starter kits to create trainings on patient involvement.

Data Monitoring Committees

This starter kit provides background reading, slides, and quizzes to create training for patients who intend to become involved in data monitoring committees.

Core reading

Phases of clinical development

Basics of Early Clinical Development

Phase I Trials

Phase II Trials

Types of Study in Early Clinical Development

Within-trial decisions: Unblinding and termination

Clinical Trial Data Safety Monitoring Board (DSMB)

Data collection in clinical trials

Statistics in Clinical Trials - Key Concepts

Assessing the value of clinical trial results

Efficacy and safety of medicines

Critical reading of clinical study results

Epidemiology

Evidence based medicine

Presentations

Early clinical development [coming soon]

Data collection in clinical trials [coming soon]

Additional Learning Resources

Are you ready to elevate your expertise with certifications in areas like Clinical Development, Medicine Discovery, and HTA Evaluation?

Explore the links below to access the EUPATI Open Classroom, choose the courses that match your interests, and embark on your learning adventure today!

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