Trials that are successfully delivered on time and to the recruitment target require the employment of good project management. High quality data is driven through data and quality management processes, and these must be combined with an understanding of the trial safety reporting requirements, and the ongoing assessment and evaluation of trial risks.
This 2 day programme will focus on the fundamentals of the project management of trials. It will explore how to plan for and respond to clinical trial challenges, maximising effectiveness, efficiency and data quality. It is aimed at individuals involved in trial co-ordination and management who have some experience at a junior level, and who would like to build on this skill set.
- Determine the factors that may contribute to the success or failure of a trial project plan for site and participant recruitment.
- Defend the implementation of flexible and adaptive trial management plans.
- Analyse the impact of one amendment or change on wider aspects of the trial.
- Describe the key risks to trial data, and formulate strategies and tools to maximise data quality.
- Discuss the potential challenges in the management of trial safety data, and propose solutions for effective trial management.
- Identify the potential barriers to effective communication, and analyse the impact of these barriers on efficient trial delivery.
The Birmingham Centre for Clinical Trials (BCCT) brings together the clinical trial expertise from across the University of Birmingham and, in particular The Birmingham Clinical Trials Unit (BCTU), and The Cancer Research UK Clinical Trials Unit (CRCTU). BCCT is one of the leading centres in the UK for designing and implementing high quality trials across a wide range of diseases and clinical settings. This course is organised by Razia Meer-Baloch (Training and Education Lead, BCTU) and Dr Sara Brookes (Training and Education Lead, CRCTU) and the programme is delivered by a wide range of clinical trials experts from across BCCT.
Is this course accredited?
The course has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 16 category 1 (external) CPD credit(s).
Who is the course for?
This course is suitable for any individual working within clinical trials who have any responsibility for trial and/or data management. This includes Trial Co-ordinators, Trial Managers, Data Managers, Project Managers, Trial Administrators, Research Nurses.
Monday 29th - Tuesday 30th November 2021