Clinical Trial Management: Maximising Effectiveness (Online)Non-credit

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.

The programme 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.

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.

Accreditation:

The course has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom for 13 category 1 (external) CPD credit(s).

Course faculty:

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 the university. It brings together the clinical trial expertise from Birmingham Clinical Trials Unit (BCTU), and the Cancer Research UK Clinical Trials Unit (CRCTU).

Dates of the course:

Iteration 1: 18^th – 19^th November 2024

Iteration 2: 24th - 25th March 2025

Iteration 3: 17th - 18th November 2025

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) - All17.00

Section 12: Summary - Razia Meer-Baloch & Becky Bishop

17.30 - Close

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.

£250 per person

Registration is open, you can register for the course using a debit/credit card 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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