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Short course

Clinical Trial Management: Maximising Effectiveness

Start date
Monday 21 November 2022
Duration
Two days
Mode
Online
Cost
£250 per person
Subject
Clinical Trial Management
Level
Postgraduate Short-Course (CPD)
This 2 day programme will focus on the fundamentals of the project management of trials. The teaching will be delivered through a combination of pre-recorded lectures; independent reading and live online sessions.

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, and who would like to build on this skill set.  

Course faculty:

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 the programme is delivered by a wide range of clinical trials experts from across BCCT.

Dates of the course:

  • 21st - 22nd November 2022 
  • 20th - 21st March 2023
  • 20th - 21st November 2023

Course programme (to be confirmed):

Day 1
09.00  Section 1: Introduction: LIVE online (Zoom) Razia Meer-Baloch
09.45  Section 2: Assessing Sites and Their Readiness to Recruit: LIVE online (Zoom) Razia Meer-Baloch & Becky Bishop
11.00  Break  
11.15  Section 3: Project Management Tools  Manjinder Kaur
11.45  Section 4: The ALL-RIC Trial (reading)  
12.30  Section 5: Trial Recruitment  Razia Meer-Baloch
13.00  Lunch  
14.00  Section 5: Trial Recruitment: LIVE online (Zoom)  Razia Meer-Baloch & Becky Bishop
15.15  Break  
15.45  Section 6: Management Safety: LIVE online (Zoom)  Matt Soden & Andrea Hodgkinson
17.00  Close  
Day 2
09.00  Section 7: Re-cap of day 1: LIVE online (Zoom) Razia Meer-Baloch & Becky Bishop
09.30  Section 8: Communication: LIVE online (Zoom) Razia Meer-Baloch & Sara Brookes
10.30  Break  
10.45  Section 9: Data Management Kirandeep Sunner 
11.30  Section 10: Risk Assessment Susannah Mee
12.00  Section 9: Data Management: LIVE online (Zoom) Matt Soden
13.15  Lunch  
14.00  Section 11: Monitoring Razia Meer-Baloch
14.30  Section 11: Monitoring: LIVE online (Zoom) Razia Meer-Baloch
15.30  Break  
16.00 Section 10: Risk Assessment: LIVE online (Zoom) All
17.00 Section 12: Summary Razia Meer-Baloch & Becky Bishop
17.30  Close  

How to apply:

Registration is open, you can register for the course using a debit/credit on the university's online shop. The courses have minimum required attendance levels and the University reserves the right to cancel or postpone the course if the minimum required number of delegates has not been achieved for the course.

For enquiries, please complete our enquiry form

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This course is suitable for individuals working within academic CTUs, NHS Trusts or industry who on behalf of the sponsor manage the trial and/or the data. This includes Trial Co-ordinators, Trial Managers, Data Managers, Project Managers, Trial Administrators & Research Nurses. The focus is on managing the trial from the sponsor perspective.

Accreditation:

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).

Learning outcomes:

  • 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.

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