Teaching and learning
The course is run sequentially over two semesters and consists of 4 modules. Learning is through a combination of formal teaching on campus for 6-8 hours on three sequential days during six blocks, directed home studies with review of selected educational material, and completion of projects for continuous assessments.
On successful completion of 30 credits, a student may exit with a Graduate Certificate in Clinical & Translational Research. These credits may also be applied towards requirements for a Graduate Diploma in Clinical & Translational Research (60 credits), ± an M.Sc. in Clinical & Translational Research: (90 credits), both of which may be completed part-time in 2014-2015.
This course requires completion of 5 modules; 4 required, and a choice of 1 of 2 optional modules.
Semester One - (Core Modules)
Principles and Practice of Clinical & Translational Research
This module forms part of the Graduate Certificate/Diploma/MSc in Clinical & Translational Research. The goal of this module is to provide an overview of the knowledge, skills and competencies that will allow them to complete a programme of clinical and translational research.
Specifically, this Module will:
- Explain the study designs used in clinical & translational research
Discuss practical methods for management of data and biological samples obtained during clinical & translational research studies
- Discuss the range of methods available for the analysis of samples obtained from clinical & translational research
- Explain statistical methods used to design and analyse clinical & translational research projects
- Review standards of Good Clinical Practice and Good Laboratory Practice in the conduct of clinical and translational research
On completion of this course students will demonstrate advanced knowledge of clinical & translational research methods. Specifically, students will be able to:
- Understand clinical & translational research principles, including study design
- Understand core methodologies used in the conduct of clinical & translational research, including data management, biological sample handling/storage, and basic data analysis
- Analyse the design of clinical & translational research projects
Data Management for Clinical Research
This module forms part of the Graduate Certificate in Cinical & Translational Research and the Graduate Diploma in Health Informatics. The goal of this module is to introduce students to key concepts in data management for clinical research. Specifically this Module will: ?- introduce students to the importance of data management for clinical research?- identify and evaluate source data?- describe methodologies for collection of data?- describe the creation of a data management plan for clinical research
On completion of this course students will be able to:
- Understand the importance of data management?
- Understand core considerations, including data security, source data, etc.?
- Create a data management plan for a clinical research project
Semester Two - (Core Modules)
Advanced Research Methods
This module prepares students working, or intending to work, in a population health or clinical setting to undertake all elements of a research project from concept through design, implementation and analysis to interpretation and presentation of findings. The focus of this module is primarily on quantitative methods, though applications to qualitative research is also covered.
At the end of this module students should be able to:
- design a quantitative epidemiological study to be carried out in a clinical, occupational or scientific setting
- develop a Research Protocol to a specified framework
- prepare a submission to a Research Ethics Committee to specified standard
- know the major epidemiological study designs
- choose the design most appropriate to the research question
- be familiar with relevant sources and types of data
- understand sampling methods and recruitment strategies
- understand power calculations / sample size estimation appropriate to the study design
- design and evaluate study instruments, including questionnaires and Case Report Forms
- oversee processes of data management, including data collection, entry and editing
- select appropriate statistical techniques for study data
- carry out basic statistical analysis
- interpret study data and present results
Biorepositories for Clinical & Translational Research
The goal of this module is to introduce students to key concepts in the collection, processing and storage of biological samples for clinical and translational research. Specifically, this Module will:
- introduce students to infrastructure of biorepository
- introduce students to the methodology of sample collection, processing and storage
- inform students of core ethical and legal considerations around sample collection
- describe in detail the theory and practicality of collection of all types of biological materials
- provide students with skills needed to create and execute a sampling plan
- provide students with invaluable practical experience of sample collection and processing
On completion of this module, students will be able to:
- understand the theory of biological material preservation
- understand the infrastructure needed to develop a biorepository
- gain practical experience in sample handing and processing
- create a sampling plan
- understand sample validation and quality control