Risk Management for Clinical Research

Ensure your clinical trials comply with the latest focus on GCP inspections and develop your own quality risk management principles and procedures

28 Mar 2019

& 23 Sep 2019

GBP 699
EUR 979
USD 1,090

Book now

Why you should attend?

Risk management is becoming increasingly important to running clinical trials. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, the revised ICH GCP R2 guideline, the revised EU Clinical Trial Regulation guideline on risk management and several other risk management clinical research standards and initiatives.

This essential one day course will explain the importance of using risk management techniques in clinical research to comply with the latest focus on GCP inspection in this area. It will show you how risk management can improve the quality of your clinical trials and demonstrate the importance of using risk analysis and risk management techniques in clinical trials. You will learn how to identify, evaluate and also how to implement specific risk-based techniques for risk management used in clinical trials.

Who should attend?

Anyone working on clinical trials including CRAs, monitors, clinical managers, project managers, lead clinical research associates, data managers and statisticians, study managers, quality assurance/audit and QC, document management. It will also be relevant to those who work alongside the study team, such as regulatory affairs.


An overview of risk management

  • Why risk management is important
  • Definitions of key risk management terminology
  • Brief overview of regulations and guidelines which cover risk management applied to clinical study-level risk management

Risk-based Quality Management System (QMS) – what does this really mean? How does it look?

  • What are the elements of a QMS which include Risk Management System (RMS)?
  • What a regulatory inspector would expect to be in place for clinical trials
  • Group discussion on RQM used

Risk-based process/tools and techniques

  • Examples of risk management process
  • Risk-based tools including
    • Root cause analysis
    • Risk breakdown structure
    • Risk log
    • Failure modes and effects analysis (FEMEA)
    • Risk matrix
    • Examples of pharmaceutical risk tools for clinical trials including RACT (Risk Assessment Categorization Tool)

Risk-based approach to the protocol

  • Quality by design (QbD) applied to the protocol
  • How this is being applied to the design of protocols

Risk-based approach to monitoring/data handling

  • Different approaches to risk-based monitoring and examples of how this is carried out – eg of a risk-based monitoring plan
  • Discussion of what approaches and documents are used
  • Case study example

Brief review of risk-based approaches to QC/QA (Auditing)

  • Example of best practice guide RQA (Research Quality Association)

Final Discussion


Laura Brown (28 Mar 2019)

Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.

Continuing professional development

This course qualifies for the following CPD programmes:

  • CPD certificate of attendance

Book now

28 Mar 2019
28 Mar 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
23 Sep 2019
23 Sep 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now

Previous customers include...

  • ADAMAS Consulting
  • AiCuris Anti-infective Cures GmbH
  • Bracco Imaging S.p.A.
  • Cancer Research UK
  • Dermal Laboratories Ltd
  • GE Healthcare Ltd
  • Glenmark Pharmaceuticals
  • GW Pharmaceuticals
  • Institut de Recherches Internationales Servier
  • Laboratoires SMB
  • Leo-Pharma A/S
  • Novo Nordisk A/S
  • ObsEva Sa
  • Opiant Pharmaceuticals
  • Sanofi Aventis Recherche & Développement
  • Summit Therapeutics

All excellent - thank you!

Christine Henderson, Group Quality & Training Director, ADAMAS Consulting