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Protocol Development

CTM201

The aim of this module is to be able to produce the protocol for a trial.

It is a core module for the MSc Clinical Trials and an option for the PG Diploma Clinical Trials.

The aim of this module is to be able to produce the protocol for a trial. Material in this module will build on the work of the core CT modules (or similar material), but will go further into the steps to be taken for preparing the protocol for a trial. For MSc CT students, it is recommended that this module is taken in the same year that students attempt the last of written papers.

Working in small groups over a 4 week period (in either autumn or spring), students will  critically appraise a systematic review provided and start drafting the background section for a trial protocol. Students can then use this as a basis for developing their own draft protocol for assessment. Note that this will not be the ‘final’ version of the protocol, but one that would be ready for consultation with stakeholders.

Credits

15 [150 hours]

Assessment

Formal assessment of the module is by an assessed assignment (80%) and 20% for contribution to group work. If you fail the module overall, you are allowed one further attempt.

For full information regarding this module please see the module specification.