Master of Science by Coursework in Clinical Trials

A. Definition of the Programme

The Divisional Board of Medical Sciences will offer a Master's Course in Clinical Trials at postgraduate level.

The Divisional Board of Medical Sciences will appoint an Organising Committee to supervise the course, which will have the power to arrange teaching, assessments and other instruction.

The Organising Committee will appoint a dissertation supervisor for each candidate.

B. Progression

Students admitted with the intention of studying towards the award of the MSc are required to matriculate, involving admission by a college of the University. Matriculation will be in absentia for MSc in Clinical Trials students.

C. Duration

To be eligible for the award of an MSc, each candidate will follow a course of study in Clinical Trials for at least six terms.

Candidates may be permitted in certain circumstances to suspend status, for a maximum of six terms. Any such period shall not count to the minimum permitted period of registration and no fee liability will be incurred during such periods.

D. Study criteria for eligibility for awards

The modules available within the Programme are specified in the Schedule below. Every candidate for the MSc award will be required to satisfy the examiners as detailed below:

(i) completion of all modules in schedulethe Schedule below;

(ii) submission of fourthree summative assessments as follows:

a) A report of not more than 2,500 words on a topic selected by the Examination Board and based on modules 1 and 2 studied as set out in the Schedule to be submitted online via the approved submission system atbefore endthe start of HilaryTrinity Term in Year 1.

b) A scientific poster based on materials studied in the first 4 modules incorporating material covered in Modules 3 and 4 to be submitted online via the approved submission system at the end of the Long Vacation in Year 1.

c) An essay of not more than 32,000500 words selected from a list provided by the Examination Board and based on modules 5 and 6 as set out in the Schedule to be submitted online via the approved submission system in MichaelmasHilary term in Year 2.

dc) A recorded 15-minute PowerPoint presentation onof ano topicmore selectedthan by10 theminutes Examination Board and based on material studied in modules 7 and 8 to be submitted online via the approved submission system at the end of Trinity term in Year 2.

(iii) Submission of a dissertation of not more than 10,000 words (excluding tables, graphs, references and bibliography), comprising a research proposal in the style of a grant application for a randomized trial, and to include a systematic review of previous evidence, on a topic selected by the candidate in consultation with the supervisor and approved by the Organising Committee. Approval must be sought no later than the end of Michaelmas term in the academic year of submission. The dissertation must be submitted online via the approved submission system, after the end of Trinity term in Year 2 on a date to be specified in the course handbook;

(iv) Attendance at theat firstleast one Residential School following at least 3 terms of study and prior to submission of the dissertation.

(v) An examination paper with questions referring to modules 1 to 4 set out in the Schedule to be held in the Long Vacation of Year 1.

E. Exit Awards

(i) Candidates who have failed the requirement of the MSc but have satisfied the requirements for the award of the Postgraduate Diploma (all the requirements for the MSc, except completion of the dissertation) may be awarded the Postgraduate Diploma.

(ii) Candidates who have satisfied the requirements for the award of the Postgraduate Diploma (all the requirements for the MSc, except completion of the dissertation) and who do not wish to continue their studies, may end their registration and at that point be awarded the Postgraduate Diploma.

Schedule

• 1. Introduction to the principles of randomised trials
  
• 2. Design to implementation
  
• 3. Data management and analysis
  
• 4. Regulatory and ethical framework and participant involvement
  
• 5. Big data, new technologies and routine health care
  
• 6. Health economics for clinical trials and patient reported outcomes
  
• 7. Meta-analysis and reporting
  
• 8. Different types of trials and populations