Protocol Development (CTM201) support expertise on trial protocols and trial leadership capacity within your CTU
Meet David – Senior Trial Manager
David has been working in clinical trials for a few years and currently holds the role of Senior Trial Manager at a Clinical Trials Unit (CTU). He has managed several multi-centre trials and is experienced in coordinating teams, overseeing trial operations, and maintaining compliance with GCP and regulatory standards.
As David takes on more responsibility in leading trial development, he is increasingly involved in early-stage trial planning and protocol drafting. While he brings extensive operational knowledge to the table, he recognises the need to strengthen his skills in the scientific and methodological aspects of protocol development, ensuring the trials he helps design are not only operationally feasible, but also scientifically robust and methodologically sound.
CTM201: Protocol Development, offered by the London School of Hygiene & Tropical Medicine, is designed for professionals like David who are stepping into roles where protocol leadership is key. This Level 7 module offers targeted, practical training in the principles and process of developing a high-quality clinical trial protocol, aligned with international standards and best practice, delivered through highly flexible, distance learning.
By completing this module, David will be able to:
- Develop and refine a research question through critical appraisal of the existing literature
- Evaluate and justify the most appropriate trial design for a given research question
- Draft a trial protocol that addresses key methodological and operational considerations, in accordance with current regulatory and ethical guidelines
- Collaborate effectively in small groups to achieve defined milestones in protocol development
Apply this knowledge to develop high-quality, fit-for-purpose clinical trial protocols that support ethical, scientifically sound, and feasible trial delivery within their CTU.
CTM201: Protocol Development provides CTUs with a valuable opportunity to strengthen protocol-writing capacity within their teams, helping mid-career staff move confidently into leadership roles in trial development.
We would welcome the chance to explore how this and other modules could support your CTU’s training strategy.