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.
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.
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.
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 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.
Dates
Monday 21 - Tuesday 22nd November 2022
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 regsiter 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.
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