Clinical Trials Research
Graduate Certificate in Clinical Trials Research
(GradCertClinT(R)) KG020 or GCCLITRR1000
Graduate Diploma in Clinical Trials Research
(GradDipClinT(R)) KF061 or GNCLITRR1000
Master of Clinical Trials Research
(MClinT(R)) KC096 or MACLITRR1000
| Course | Credit points for award | Duration |
|---|---|---|
| GradCertClinT(R) | 24 | 1 to 3 years* |
| GradDipClinT(R) | 36 | 1.5 to 3 years* |
| MClinT(R) | 48 | 2 to 6 years* |
*currently offered on a part-time basis only
Overview
The aim of the online Clinical Trials Research course is to provide a distinctive program targeted at medical doctors and allied health professionals, to help them acquire the expertise needed to design, develop, lead and conduct clinical trials. The course is led by the NHMRC Clinical Trials Centre (CTC), Australia's premier academic clinical trials research organisation. The NHMRC CTC course focuses on clinical trials design and research methodology and is offered via distance learning only. Graduates will gain a solid understanding of clinical trials methodologies underpinning the design of high quality studies, and the knowledge to lead, conduct and appropriately interpret the results of single and multi-centre clinical trials.
Course outcomes
Graduates will:
- understand the advantages and limitations of various trial designs
- gain a solid understanding of different scientific research methods that underpin the design of high quality clinical studies
- be able to lead and/or contribute to designing, efficiently conducting and appropriately interpreting the results of single and multi-centre clinical trials
- be able to identify and understand the appropriate literature with respect to clinical questions and clinical trials design
- have a solid understanding of the clinical trial process including the design, scheduling of intervention, the statistical and ethical considerations, selection of participants and delivery of the intervention.
Information about the programs
The graduate certificate requires students to undertake 24 credit points of study comprising four core units of study.
The graduate diploma requires 36 credit points of study comprising six core units of study.
The master's requires 48 credit points of study comprising six core units, a choice of electives (up to 6 credit points), and a capstone unit. The capstone unit will require each student to bring together concepts, principles and applications developed in the previous units of coursework study into a workable research protocol or project. The capstone will test the student's ability to integrate and consolidate their learning.
Flexible learning
The Clinical Trials Research courses are delivered 100 percent online, including lectures, tutorials, discussion forums and supplementary materials.
Pattern of enrolment
In order to progress through the program, the following pattern of enrolment is suggested.
Year 1
| UoS code and name | Credit points |
|---|---|
| Semester 1 | |
| CLTR5000 Critical Appraisal of Evidence |
6 |
| CLTR5001 Trial Design and Methods |
6 |
| Semester 2 | |
| NURS5068 Clinical Trials in Practice |
6 |
| CLTR5007 Statistical Principles & Clinical Trials |
6 |
Year 2
| UoS code and name | Credit points |
|---|---|
| Semester 1 | |
| CLTR5002 Interpretation of Trial Analyses |
6 |
| CLTR5003 Leadership and Problem Solving |
6 |
| Semester 2 | |
| Elective | 6 |
| CLTR5008 Research Project |
6 |
Further enquiries
Adrienne Kirby
Phone: +61 2 9562 5064
Email:
Website: http://www.ctc.usyd.edu.au/education.aspx
Degree resolutions
Sydney Medical School resolutions and the printed handbook are the official statement of Faculty policy. The resolutions contained in the printed handbook are accurate as at August 2013. If a conflict is perceived between the content of the printed handbook and information available elsewhere, Sydney Medical School resolutions and the information available in the handbook online shall always take precedence. See the handbook online website:
sydney.edu.au/handbooks/medicine/
See the Policy Online website: sydney.edu.au/policy, for copies of University policies.
Master of Clinical Trials Research
These resolutions must be read in conjunction with applicable University By-laws, Rules and policies including (but not limited to) the University of Sydney (Coursework) Rule 2000 (the 'Coursework Rule'), the Resolutions of the Faculty, the University of Sydney (Student Appeals against Academic Decisions) Rule 2006 (as amended) and the Academic Board policies on Academic Dishonesty and Plagiarism.
Course resolutions
1 Course codes
| Code | Course title |
|---|---|
| KG020 |
Graduate Certificate in Clinical Trials Research |
| KF061 | Graduate Diploma in Clinical Trials Research |
| KC096 | Master of Clinical Trials Research |
2 Attendance pattern
3 Master's type
0.
The master's degrees in these resolutions are advanced learning master's courses, as defined by the Coursework Rule.
4 Cross-faculty management
(1)
Candidates in Clinical Trials Research courses will be under the general supervision of the Faculty of Medicine and will be governed by the resolutions of the Faculty of Medicine.
(2)
Candidates in Clinical Trials Practice courses will be under the general supervision of the Faculty of Nursing and Midwifery and will be governed by the resolutions of the Faculty of Nursing and Midwifery.
(3)
The Deans of the Faculty of Medicine and the Faculty of Nursing and Midwifery shall jointly exercise authority in any matter concerned with the combined course units not otherwise dealt with in these resolutions.
5 Embedded courses in this sequence
(2)
Providing candidates satisfy the admission requirements for each stage, a candidate may progress to the award of any of the courses in this sequence. Only the longest award completed will be conferred.
6 Admission to candidature
(1)
Available places will be offered to qualified applicants according to the following admission criteria. In exceptional circumstances the dean may admit applicants without this qualification who, in the opinion of the Faculty, have qualifications, evidence of experience and achievement sufficient to successfully undertake the award.
0.0
a bachelor's degree in a relevant discipline from the University of Sydney or equivalent qualification.
0.0
a bachelor's degree in a relevant discipline from the University of Sydney or equivalent qualification;
0.0
completion of the requirements of the embedded Graduate Certificate in Clinical Trials Research from the University of Sydney;
0.0
a Graduate Certificate in Clinical Trials Practice from the University of Sydney, or equivalent qualification.
0.0
a bachelor's degree with a first or second class honours in a relevant discipline from the University of Sydney or equivalent qualification;
0.0
a Graduate Certificate in Clinical Trials Practice from the University of Sydney or equivalent qualification;
0.0
a graduate diploma in a relevant discipline from the University of Sydney or equivalent qualification;
0.0
completion of the requirements of the embedded Graduate Certificate or Graduate Diploma in Clinical Trials Research from the University of Sydney, or equivalent qualification.
7 Requirements for award
(1)
The units of study that may be taken for the courses are set out in the Table of Units of Study: Clinical Trials Research
(2)
To qualify for the award of the Graduate Certificate in Clinical Trials Research a candidate must successfully complete 24 credit points of core units of study.
(3)
To qualify for the award of the Graduate Diploma in Clinical Trials Research, a candidate must successfully complete 36 credit points of core units of study
(4)
To qualify for the award of the Master of Clinical Trials Research, a candidate must successfully complete 48 credit points, including:
(5)
Candidates are required to attend clinical simulation and fieldwork as prescribed. Where appropriate, the Faculty may require individual candidates to undertake further or remedial theoretical, clinical or practical study in addition to the above requirements.
8 Credit
0.
Students in the Graduate Diploma in Clinical Trials Research and Master of Clinical Trials Research who have previously completed the Graduate Certificate in Clinical Trials Practice, Graduate Diploma in Clinical Trials Practice or Master of Clinical Trials Practice may be granted up to a maximum of 12 credit points of credit toward the new award for units of study undertaken in the previous courses. Credit shall otherwise be granted in accordance with the Coursework Rule.
Table of units of study: Clinical Trials Research
| Unit of study | Credit points | A: Assumed knowledge P: Prerequisites C: Corequisites N: Prohibition | Session |
|---|---|---|---|
Core units |
|||
| CLTR5001 Trial Design and Methods |
6 | Semester 1 |
|
| CLTR5000 Critical Appraisal of Evidence |
6 | Semester 1 |
|
| CLTR5007 Statistical Principles & Clinical Trials |
6 | P CLTR5001 |
Semester 2 |
| NURS5068 Clinical Trials in Practice |
6 | Semester 2 |
|
Additional core units for diploma and master's students |
|||
| CLTR5002 Interpretation of Trial Analyses |
6 | P CLTR5001, CLTR5007 |
Semester 1 |
| CLTR5003 Leadership and Problem Solving |
6 | P CLTR5001 |
Semester 1 |
Elective units |
|||
| CLTR5004 Advanced Trial Design |
6 | P CLTR5001, CLTR5007 |
Semester 2 |
| CLTR5005 Global Biomarker Studies |
6 | P CLTR5001 |
Semester 2 |
| CLTR5006 Health Economics and Decision Analysis |
6 | P CLTR5001 |
Semester 2 |
Capstone for master's students |
|||
| CLTR5008 Research Project |
6 | P CLTR5001, CLTR5007 |
Semester 2 |
Units of study descriptions for 2013
CLTR5000 Critical Appraisal of Evidence
Credit points: 6 Session: Semester 1 Classes: discussion groups and problem based learning Assessment: 1quiz (10%), 2x assessments (40%) and (50%) Campus: Camperdown/Darlington Mode of delivery: On-line
The candidate will develop the skills necessary to synthesize evidence both in preparation for conducting a trial and how to incorporate trial results into existing evidence. This will include being able to conduct a systematic review of the literature, including understanding how to appropriately assess evidence. The principles of meta-analysis to combine the results of multiple trials will also be examined as well as the interpretation of these results and how they can be used in clinical practice guideline development. As part of the critical appraisal of available evidence, different patient outcomes and the corresponding summary endpoint measures will be examined. Additionally the sources of biases arising from different trial designs and outcome measures will be covered and incorporated as part of the critical appraisal of available evidence (including published papers).
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5001 Trial Design and Methods
Credit points: 6 Session: Semester 1 Classes: discussion groups and problem based learning Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
This unit of study will focus on the strengths and weaknesses of different clinical study designs. Designs considered will include cohort (retrospective and prospective), cross-sectional, case-control and randomized controlled designs. The different phases of clinical trial designs in the development of therapies will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Extension and adaption of randomized designs will also be covered including cluster and factorial designs and adaptive pilot studies. Students will gain the skills necessary to choose between these designs for best practice. Types of outcomes (continuous, categorical, time-to-event) will be discussed. Methods of allocating participants to interventions (randomization), as well blinding and allocation concealment will be covered together with aspects of protocol development. On completion of this unit, the student will be familiar with the differences between study types and study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop stratified randomisation schemes for their own studies.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5002 Interpretation of Trial Analyses
Credit points: 6 Session: Semester 1 Classes: discussion groups and problem based learning Prerequisites: CLTR5001, CLTR5007 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
This unit addresses a number of key issues that arise in the analysis of clinical trial data. It will equip students with the ability to critically evaluate and interpret trial analyses, as well as provide them with an understanding of the principles underpinning good analysis practices. Modules will provide an introduction to the interpretation of treatment effect estimates, adjusted analyses, subgroup analysis, interim analyses, and how to reach appropriate decisions about the continued evaluation of an intervention, or its recommended implementation in practice.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5003 Leadership and Problem Solving
Credit points: 6 Session: Semester 1 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: 2x quizzes (2x10%) 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
The candidate will understand how to effectively form, lead and successfully manage a clinical research project. The subject will address issues related to resource management (including team and finance). The key elements of putting together a solid funding application will also be covered. Specialized aspects of trial management and conduct will be presented. Issues involved in study start up (initiation), monitoring and quality assurance (including audit), and study outcome collection will be introduced. Aspects of scientific leadership including skills to address/solve problems in recruitment, follow up and event assessment will be taught. Students will gain a detailed understanding of how to plan for issues arising during a clinical trial in a practical sense including dealing with unexpected events during a trial, addressing event rates lower than that expected, changes in outcome definitions and ethical dilemmas. This is a key subject where students will gain an understaningof how to apply theory to practice.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5004 Advanced Trial Design
Credit points: 6 Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001, CLTR5007 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
Candidates will be taught skills to design and interpret equivalence trials, non-inferiority trials and cluster randomised trials. Specialised designs including enrichment and discontinuation designs will be discussed and special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite, co-primary and surrogate endpoints will be covered. Distinctions between event and chronological time directed outcomes will be discussed. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5005 Global Biomarker Studies
Credit points: 6 Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
The special skills of translational research will be highlighted in this unit. Candidates will understand how to incorporate bio-marker, DNA and tissue sample collection and analysis into clinical research projects. Use of these materials for predicting prognosis and responses to treatment will be taught. The complexities of international regulations regarding sample collection and shipment will be highlighted.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5006 Health Economics and Decision Analysis
Credit points: 6 Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
Candidates will acquire the ability to undertake decision analysis to inform policy. Practical application of health economic principles within clinical trials will be understood. The collection and analysis of patient related outcomes and health utilities will be taught. The principles of cost- effectiveness analysis will be covered.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5007 Statistical Principles & Clinical Trials
Credit points: 6 Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: On-line
Statistical principles and concepts required to design, lead and manage clinical trials will be introduced, including the appraisal of the appropriateness of analyses appearing in previous trial reports. Concepts which will be developed include an understanding of simple and adjusted analyses. Students will undertake analyses of actual studies having outcomes which are continuous, binary and time-to-event including Kaplan-Meier and logrank tests. Concept and issues involved in performing landmark analyses will be introduced. Identification of key prognostic variables and their interpretation in a clinical trials context will be introduced. The basis for and understanding of detailed sample sized calculations for student's own trial proposals will be covered.
Textbooks
Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5008 Research Project
Credit points: 6 Session: Semester 2 Prerequisites: CLTR5001, CLTR5007 Assessment: Dissertation (100%) Campus: Camperdown/Darlington Mode of delivery: On-line
The capstone unit is a project which requires each student to bring together concepts, principles and applications developed in the previous units of coursework study into a workable research proposal and plan for the initiation and management of a clinical trial. The capstone will test the student's ability to integrate and consolidate their learning.
Textbooks
Recommended reading: Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
NURS5068 Clinical Trials in Practice
Credit points: 6 Session: Semester 2 Classes: on-line Assessment: 2500wd assignment (40%) and 1500wd assignment (30%) and online activities (30%) Campus: Mallett Street Mode of delivery: On-line
This unit of study will provide students with the knowledge and skills of translating clinical trials methods and theory into practice. Students will be introduced to principles of clinical trial project management including the management of patient recruitment and follow up, monitoring study progress, clinical trial budgeting and funding. This unit of study will also focus on the ethical and legal framework which governs clinical trials including ethics approval, informing patients, and obtaining consent in the context of clinical trials and various patient populations. A key feature of clinical trials relates to quality assurance aspects such as documentation of study procedures and clinical trial audit, consequently emphasis will be placed on the development of clinical trials reports, results and publications.