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Study-level Risk Management    Back

ICR -The Institute of Clinical Research Course Type: Short courses (CPD) Start Date: To be announced
Duration: Full time - 1 Day


This course to provides delegates with an understanding of a risk-based approach to clinical trials. By the end of this course delegates will be able to:

  • Review the basics principles of risk management and how to utilise them to take a risk-based approach

  • Plan a risk management workshop for a clinical trial

  • Identify the people to involve in a risk management workshop for a clinical trial

  • Document the risks identified during a risk management workshop

  • Prioritise risks and plan mitigation actions where necessary

Course outline

  • Review of basic risk management methodology

  • Who should do what?

  • What aspects of a clinical trial may generate risks?

  • What should the risk documentation look like and how do you use it?

  • When should risk assessment take place?

  • How do you decide what actions to take?

  • Who should be involved in trial risk assessment?

  • How do you get started?

Who will benefit?

This course is designed for, clinical trial monitors, data managers, statisticians, study managers and supporting roles within the wider study team.

Enquire on website for more information. 

Prior knowledge of basic FDA guidelines is a prerequisite of this course and therefore should be read prior to coming. A copy can be viewed at

Short courses (CPD) - Full time

1 Day
Teaching method:


Course contact information

This course meets 5 out of 9 IMI Education & Training shared quality standards ( Show Details)
  • A predefined set of teaching objectives, leading to defined learning outcomes
  • Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
  • A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
  • Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
  • Defined and transparent admission criteria
  • Quality assurance of teaching staff
  • Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
  • The facilities, infrastructure, leadership and competences available for the support of student learning
  • University accreditation OR a system for approving, monitoring and reviewing the training offered
Last update: 19/08/2016