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Students will carry out an independent research project supervised by a member of ICTM staff. Students will develop their projects in consultation with their ICTM supervisor and through their own self-directed reading and application of research methods.

In Term 1, students will choose a topic from a range of subjects, including reviews of literature, collecting and/or analysing data sets to provide new information relevant to clinical trials or addressing challenges in trials. There is a wealth of data from the many ongoing trials at ICTM. Research project could be based on trial data already collected as part of these trials and could focus on, for example, improving trial processes (e.g. use of electronic healthcare data in follow up of participants/ascertaining trial outcomes) or a secondary study addressing an aspect not previously explored. Some examples of projects are included below:

• Literature-based dissertation: critical study of existing clinical trial methodology (any aspect of clinical trial design, conduct, analysis or reporting) and suggestions for improvement
• Primary research: literature review and quantitative and/or qualitative data collection and analysis for which ethics board approval must be in place before student begins project (if required)
• Secondary data analysis: literature review and either secondary analysis of existing clinical trial data or meta-analysis of a number of published clinical trials
• Action plan: literature review and plan for future clinical trial or study within a trial. The dissertation would include a background and rationale for the trial/question and a description of the proposed methodology and analysis methods (eg. protocol)
• Develop a piece of training to improve clinical trial design, conduct, analysis or reporting

The students will be encouraged to explore their ideas with lecturers on the course or discuss with the Programme Leads who will be able to suggest a potential ICTM supervisor.

If required, the supervisor will ensure that ethical approval is obtained. The students will be expected to contribute to the writing of the ethics application and submission. This would be part of the detailed methodology of the project. If approval is not obtained in time, the Programme Lead will explore alternative options for the student’s project early on in Term 2.

During Term 1, the cohort will be guided on how to write a research proposal, with IT training and library support provided throughout. They will finalise their proposal during Term 1 so that they are ready to undertake the practical aspects of their project during Term 2.

In Term 2, during week 1 of teaching the students will present their project proposals. The rest of the term they will focus on their project work around their lectures which would be a the most be delivered over two days of the week.

In Term 3, the students will submit their dissertation.

Support will be available from the Project Supervisor and Programme Directors. The students will be expected to adhere to a series of deadlines to plan, draft and deliver their dissertations.

The cohort will be receive training on the following using a mixture of face-to-face and remote learning (as appropriate) to guide them through the different phases of the project:

• • Basic software packages for analysis and presentation of data (much of this would have been covered during Term 1)
  • Literature searches using PubMed - the students will receive guidance and support from Term 1 which will continue throughout Terms 2 & 3. The cohort will be guided on the use of EndNote or similar Reference manager
  • Powerpoint presentations
  • Interactive workshops on scientific writing
  • Various other workshops will be organised as the need arises using the expertise within ICTM