Clinical Trials Research
Graduate Certificate in Clinical Trials Research
(GradCertClinT(R)) KG020
Graduate Diploma in Clinical Trials Research
(GradDipClinT(R)) KF061
Master of Clinical Trials Research
(MClinT(R)) KC096
| 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 |
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 acquire the expertise needed to design, develop, lead and conduct clinical trials. The course will be lead by the NHMRC Clinical Trials Centre (CTC), Australia's premier academic clinical trials research organisation. The proposed NHMRC CTC course is specifically focused on clinical trials design and research methodology and is offered via distance learning. As a result of participation, graduates will have a solid understanding of clinical trials methodologies underpinning the design of good quality studies, as well as the knowledge to lead and/or design, conduct and appropriately interpret the results of single and multi-centre clinical trials. This course is complementary to a parallel course developed by the Faculty of Nursing and Midwifery, the Master of Clinical Trials Practice. The Master of Clinical Trials Practice course is specifically focused on the practical aspects of conducting clinical trials for nurses and allied health professionals.
Course Outcomes
As a result of participation, graduates will:
- have a solid understanding of different scientific research methodologies that underpin the design of good quality studies
- 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 delivery, appropriate doses of treatment, the statistical and ethical considerations.
Information about the programs
The Graduate Certificate of Clinical Trials Research requires students to undertake 24 credit points of study comprising 4 core units subjects.
The Graduate Diploma of Clinical Trials Research requires 36 credit points of study comprising 6 core units.
The Master of Clinical Trials Research requires 48 credit points of study comprising 6 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% online, including lectures, tutorials, discussion forums and supplementary materials.
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 November 2010. 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:
http://sydney.edu.au/handbooks/handbooks_admin/medicine.shtml.
See the Policy Online website: http://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
0.
The attendance pattern for these courses is full time or part time according to candidate choice.
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 in a relevant discipline from the University of Sydney or equivalent qualification, with a credit average;
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 |
|||
| NURS5068 Clinical Trials in Practice |
6 | Semester 2 |
|
| CLTR5001 Trial Design and Methods |
6 | Semester 1 |
|
| CLTR5000 Critical Appraisal of Evidence |
6 | Semester 1 |
|
| CLTR5007 Understanding Trials Methods |
6 | P CLTR5001 |
Semester 2 |
Additional core units for Diploma and Master students |
|||
| CLTR5002 Issues & Interpretation: Trial Analysis |
6 | P CLTR5001, NURS5068 |
Semester 1 |
| CLTR5003 Leadership and Problem Solving |
6 | P CLTR5001 |
Semester 1 |
Elective Units |
|||
| CLTR5004 Advanced Trial Design |
6 | P CLTR5001, NURS5068 |
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 students |
|||
| CLTR5008 Research Project |
6 | P CLTR5001, CLTR5007 |
Semester 2 |
Further enquiries
Adrienne Kirby
Phone: +61 2 9562 5064
Email:
Pattern of Enrolment
In order to progress through the program, the following pattern of enrolment is suggested.
| Semester 1 year 1 UoS code and name |
Credit points |
|---|---|
| CLTR5000 Critical Appraisal of Evidence |
6 |
| CLTR5001 Trial Design and Methods | 6 |
| Semester 2 year 1 UoS code and name |
Credit points |
|---|---|
| NURS5068 Clinical Trials in Practice |
6 |
| CLTR5007 Understanding Trials Methods | 6 |
| Semester 1 year 2 UoS code and name |
Credit points |
|---|---|
| CLTR5002 Issues & Interpretation:Trial Analysis | 6 |
| CLTR5003 Leadership and Problem Solving | 6 |
| Semester 2 year 2 UoS code and name |
Credit points |
|---|---|
| Elective |
6 |
| CLTR5008 Research Project | 6 |
Units of Study Descriptions for 2011
CLTR5000 Critical Appraisal of Evidence
Credit points: 6 Session: Semester 1 Classes: discussion groups and problem based learning Assessment: Exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
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 taught, how to interpret these and how they can be used in clinical practice guideline development.
Textbooks
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: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
This unit of study will focus on different clinical study designs and their various strengths and weaknesses. The different phases of trials will be studied. Candidates will gain the skills necessary to choose between these designs for best practice. Types of outcomes and the appropriate analyses will be discussed. Methods of allocating participants to interventions, as well as approaches to the analysis and interpretation of the data arising from studies using these designs will be addressed. Protocol development will be covered. On completion of this unit, the student will be familiar with distinct methods of analysis relating to various study designs, as well as the principles and practice of randomisation. It is also expected that the candidate will be able to develop simple stratified randomisation scheme for their own studies.
Textbooks
Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5002 Issues & Interpretation: Trial Analysis
Credit points: 6 Session: Semester 1 Classes: discussion groups and problem based learning Prerequisites: CLTR5001, NURS5068 Assessment: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
This unit will cover simple summary statistics appropriate for different study designs. The candidate will have an understanding of the limitations and correct analysis of sub-groups, multiple testing and interim analysis, including an introduction to early- stopping rules. The impact of missing data and concepts of sensitivity analysis will be taught. The candidate will learn how to interpret cumulative hazard curves and summary statistics including odds ratios and hazard ratios. The advantages and disadvantages of missing data imputation will be studied.
Textbooks
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: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
The candidate will understand how to effectively form, lead and successfully manage a clinical research team and budget appropriately. He or she will gain a detailed understanding of how to plan for unexpected low event rates, changes in outcome definitions or available tests and ethical dilemmas arising during a clinical trial. Key elements of putting together a solid funding application will be taught. Specialised aspects of trial management and conduct with respect to interim analyses and study outcomes collection will be understood. Strategies to improve the practical nature of clinical trials. Skills to solve problems in recruitment follow up and event assessment will be taught.
Textbooks
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, NURS5068 Assessment: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
Candidates will understand and obtain skills to design and analyse equivalence trials, non-inferiority trials and cluster randomised trials. Special aspects relating to cross-over studies will be taught. Techniques to validly incorporate composite end points and co-primary endpoints will be learnt. Skills to incorporate sub-studies into clinical research projects will be covered in this unit.
Textbooks
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: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
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 learnt. The complexities of international regulations regarding sample collection and shipment will be highlighted.
Textbooks
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: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
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
Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
CLTR5007 Understanding Trials Methods
Credit points: 6 Session: Semester 2 Classes: discussion groups and problem based learning Prerequisites: CLTR5001 Assessment: exam (40%), 3x assessments (60%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
Candidates will understand the statistical principles and concepts required to design, lead and manage clinical trials. They will be able to identify whether appropriate analyses have been undertaken in previous trial reports. They will understand the basis for, and be able to undertake, detailed sample sized calculations for their own trial proposals. They will be able to undertake basic analysis of clinical trial datasets and test for significant effects of treatments.
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: Distance Education
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
Interpreting and Reporting of Clinical Trials: a guide to the Consort statement.
NURS5068 Clinical Trials in Practice
Credit points: 6 Session: Semester 2 Classes: distance education/intensive on campus, up to 5 study days Assessment: 2500wd assignment (35%) and 3000wd assignment (40%) and online activities (25%) Campus: Mallett Street Mode of delivery: Distance Education/Intensive on Campus
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.