This module provides students with theoretical and practical perspectives of the conduct of patient-centred research. In this clinical research course students will explore issues related to the management of clinical trials, safety monitoring, regulatory issues, data analysis, reporting of trials and contemporary study designs.
Principal module aims
This module enables students to:
Demonstrate data management and analysis approaches relevant to clinical trials.
Consider issues of safety and regulatory obligations involved in managing clinical trials.
Communicate effectively and clearly on clinical trial design, management, and outcomes.
Use appropriate project management techniques to manage clinical trials.
Identify and discuss important issues in data management in clinical trials.
Critically evaluate safety monitoring issues in clinical trials.
Compare and contrast local and international and global regulatory issues affecting the design and execution of clinical trials.
Identify the appropriate data analysis techniques appropriate to particular study objectives.
Evaluate the key elements of longitudinal data analysis and meta-analysis.
Explain contemporary clinical trial designs, including adaptive and translational study designs.
Demonstrate the capacity to communicate information on clinical trial design, conduct and outcomes to a range of audiences.
The outline syllabus gives an indication of the sort of topics that will be covered in the module.
Ethics, privacy and safety in clinical trials.
Clinical Trial management and conduct
Measurement of clinical trials and data capture.
Data monitoring and analysis.
Reporting of Results
Regulatory issues in clinical trials.
Part A: Critical Evaluation (80% of grade)
Review the provided scenarios. Critically evaluate the issues (including design, ethics and governance) inherent in developing, implementing, monitoring and reporting complex, multi-center Randomised Control Trials. Include proposed mechanisms for resolution of these issues.
Part B: Presentation (20% of grade)
A 10-minute pre-recorded presentation on the management of person-centred research