Clinical Trial Management

Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time): Module Code 7MCS0017

This module provides, over five days, an in-depth understanding of the practical issues associated with running clinical trials, including large scale multi-national projects, the standard tools available to managers to ensure that projects are completed according to plan and particularly the standard repertoire of activities and responses used to ensure optimal communication with investigators and other parties. This specialist module gives students the knowledge and skills needed to run clinical trials, including large multi-national ones. Students will learn the standard communication, tracking and problem solving tools that project managers use to ensure that projects are completed to plan.

• Gives students an in depth understanding of the roles and responsibilities of the clinical trial Investigator and investigator site staff.
• Provides an in depth understanding of the roles and responsibilities of the clinical trial Sponsor and Monitor.
• Instils a deep understanding and appreciation methods and technologies available to project manage clinical trials.
• Enable students to predict and problem-solve the common challenges withy the conduct of clinical trials.
• Provides students with an in-depth appreciation of the benefits and challenges with conducting multi-centre, multinational clinical trials.

By the end of this module students will be able to:

• Critically appraise systems that allow the generation and retrieval of clinical trial documentation required by regulations and good practice.
• Create a plan that maps the execution of a multisite clinical trials various activities, e.g., patient recruitment; adverse events and data collection against plans over the lifetime of the project, using suitable project tracking tools.
• Design strategies that address project problems, e.g., slow data flow, poor team dynamics, and quality of clinical trial supplies.

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject. The course will suit individuals seeking to develop a practical understanding of the management of clinical trials e.g. pharmaceutical physicians, scientists in R&D and medical affairs, and regulatory affairs personnel.