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In this module you will learn about some of the practical aspects of managing open trials, from the moment the first participant is recruited up until the trial is closed, the data is analysed and the results are communicated. We will cover how data is collected and managed, how trials are monitored and the process for reporting issues. We will also discuss how and why trials are amended, different strategies to ensure optimal recruitment and retention of participants and the role of audits and inspections in ensuring compliance with good clinical practice. You will learn how to close trials centrally, and at each active site, and the potential implications of trials being terminated prematurely. We will also discuss how the results of a trial are collated and written up for publication. You will learn the importance of patient and public involvement in trial oversight and when preparing and reporting trial results. Finally, we will discuss how clinical trials results are communicated appropriately and effectively to different audiences.

At the end of this module, you will be able to:

1. Construct/assess data management plans for a range of trials, identify possible data management risks and provide potential solutions.
2. Describe the importance of appropriate trial oversight and identify the roles and responsibilities of the trial team and other committees/stakeholders.
3. Identify the steps involved in closing a clinical trial and formulate a plan of action to manage the premature (and unexpected) closure of a trial either for benefit, for harm or for lack of benefit/futility.
4. Evaluate strategies for enhancing participant accrual, adherence and retention in clinical trials.
5. Communicate clinical trial results appropriately to different audiences.