Clinical Trials Practice
Sydney Nursing School offers the following clinical trials practice courses:
- Graduate Certificate in Clinical Trials Practice
- Graduate Diploma in Clinial Trials Practice
- Master of Clinical Trials Practice
Graduate Certificate in Clinical Trials Practice GG014
Course overview
The Graduate Certificate in Clinical Trials Practice consists of two semesters of part-time study. Students are required to complete 24 credit points or four units of study as prescribed in the unit of study table related to this program.
Students may articulate from a graduate certificate into a master’s degree. Units studied at the graduate certificate level are, in most cases, credited towards the higher qualification.
Workload
The Graduate Certificate in Clinical Trials Practice may only be studied by local students in the part-time mode. Students generally undertake two units of study per semester. All units are offered in intensive on-campus mode with students required to attend study days and undertake e-learning and independent study. Assessment consists of written assignments, clinical assessments and examinations.
Graduate Diploma in Clinical Trials Practice GF020
Course overview
The Graduate Diploma in Clinical Trials Practice may be completed in one year of full-time study or two years of part-time study. The graduate diploma consists of 36 credit points or six units of study as prescribed in the unit of study table related to this program.
Workload
Students generally undertake four units of study per semester full time. Students studying part time will undertake two units of study per semester. All units are offered in intensive on-campus mode with students required to attend study days and undertake e-learning and independent study. Assessment consists of written assignments and examinations.
Master of Clinical Trials Practice GC058
Course overview
The Master of Clinical Trials Practice consists of 48 credit points or eight units of study as prescribed in the unit of study table related to this program. This may be taken over one year of full-time study, or two years of part-time study.
Workload
Students generally undertake four units of study per semester full time. Students studying part time will undertake two units of study per semester. In the final semester students will undertake a six credit point unit of study (the Capstone) and will study part time. All units are offered in intensive on-campus mode with students required to attend study days and undertake e-learning and independent study. Assessment consists of written assignments and examinations.
Unit of study table
| Unit of study | Credit points | A: Assumed knowledge P: Prerequisites C: Corequisites N: Prohibition | Session |
|---|---|---|---|
Graduate Certificate in Clinical Trials Practice GC014 |
|||
| Students in the Graduate Certificate in Clinical Trials Practice are required to complete 24 credit points from the following units of study: | |||
| NURS5066 Foundations of Clinical Trials |
6 |
Note: Department permission required for enrolment |
Semester 1 |
| NURS5069 Research in Nursing and Health Care |
6 | Semester 1 |
|
| NURS5067 Clinical Trials: Measurement & Analysis |
6 |
Note: Department permission required for enrolment |
Semester 2 |
| NURS5068 Clinical Trials in Practice |
6 | Semester 2 |
|
Graduate Diploma in Clinical Trials Practice GF020 |
|||
| Students in the Graduate Diploma in Clinical Trials Practice are required to complete 36 credit points. This includes 30 credit points from the following units of study and a 6 credit point elective: | |||
| NURS5066 Foundations of Clinical Trials |
6 |
Note: Department permission required for enrolment |
Semester 1 |
| NURS5069 Research in Nursing and Health Care |
6 | Semester 1 |
|
| CLTR5001 Trial Design and Methods |
6 | Semester 1 |
|
| NURS5067 Clinical Trials: Measurement & Analysis |
6 |
Note: Department permission required for enrolment |
Semester 2 |
| NURS5068 Clinical Trials in Practice |
6 | Semester 2 |
|
| A 6 credit point elective unit of study (see coordinator for advice) | |||
Master of Clinical Trials Practice GC058 (Part-time) |
|||
| Students in the Master of Clinical Trials Practice are required to complete 48 credit points. This includes 30 credit points from the following units of study, 12 credit points of elective units of study, and a 6 credit point capstone, as follows: | |||
Year 1, Semester 1 |
|||
| NURS5066 Foundations of Clinical Trials |
6 |
Note: Department permission required for enrolment |
Semester 1 |
| NURS5069 Research in Nursing and Health Care |
6 | Semester 1 |
|
Year 1, Semester 2 |
|||
| NURS5067 Clinical Trials: Measurement & Analysis |
6 |
Note: Department permission required for enrolment |
Semester 2 |
| NURS5068 Clinical Trials in Practice |
6 | Semester 2 |
|
Year 2, Semester 1 |
|||
| CLTR5001 Trial Design and Methods |
6 | Semester 1 |
|
| A 6 credit point elective unit of study (see coordinator for advice) | |||
Year 2, Semester 2 |
|||
| NURS5092 Capstone (Clinical Trials Practice) |
6 |
Note: Department permission required for enrolment |
Semester 1 Semester 2 |
| A 6 credit point elective unit of study (see coordinator for advice) | |||
Master of Clinical Trials Practice GC058 (Full-time) |
|||
| Students in the Master of Clinical Trials Practice are required to complete 48 credit points. This includes 30 credit points from the following units of study, 12 credit points of elective units of study, and a 6 credit point capstone, as follows: | |||
Semester 1 |
|||
| NURS5066 Foundations of Clinical Trials |
6 |
Note: Department permission required for enrolment |
Semester 1 |
| NURS5069 Research in Nursing and Health Care |
6 | Semester 1 |
|
| CLTR5001 Trial Design and Methods |
6 | Semester 1 |
|
| A 6 credit point elective unit of study (see coordinator for advice) | |||
Semester 2 |
|||
| NURS5067 Clinical Trials: Measurement & Analysis |
6 |
Note: Department permission required for enrolment |
Semester 2 |
| NURS5068 Clinical Trials in Practice |
6 | Semester 2 |
|
| A 6 credit point elective unit of study (see coordinator for advice) | |||
| NURS5092 Capstone (Clinical Trials Practice) |
6 |
Note: Department permission required for enrolment |
Semester 1 Semester 2 |
Unit of study descriptions
CLTR5001 Trial Design and Methods
Credit points: 6 Session: Semester 1 Assessment: 2x quizzes (2x10%), 2x assessments (2x40%) Campus: Camperdown/Darlington Mode of delivery: Distance Education
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. Different phases of clinical trial designs will also be examined including phase I (first in man), phase II/pilot and phase III comparative designs. Different aspects of randomized designs will also be covered included 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 as well as aspects of protocol development will be covered. 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 scheme for their own studies.
NURS5066 Foundations of Clinical Trials
Credit points: 6 Session: Semester 1 Assessment: 2500wd assignment (50%), 2hr exam (30%) and online activities (20%) Campus: Mallett Street Mode of delivery: Distance Education/Intensive on Campus
Note: Department permission required for enrolment
A fundamental understanding of clinical trials methods is critical to the role of both the clinical research nurse and professional. This unit of study will focus on clinical trial design from human phase I studies through to late phase trials. We will introduce, examine and critique clinical trial design features and concepts such as selecting the right patient population, randomisation and blinding, concepts of internal and external validity, defining study endpoints and choosing appropriate outcome measures. Students will also gain insight into how clinical trial questions are formulated from initial concept through to the development of a clinical trial protocol. Throughout this unit of study students will be exposed to a number of clinical trial design case studies, including those testing both pharmacologic and non-pharmacologic interventions.
NURS5067 Clinical Trials: Measurement & Analysis
Credit points: 6 Session: Semester 2 Assessment: 3000wd assignment (35%) and mini poster (35%) and case study (30%) Campus: Mallett Street Mode of delivery: Distance Education/Intensive on Campus
Note: Department permission required for enrolment
A fundamental understanding of biological measurement and the analysis of clinical trial data is critical to the application of clinical trials methods. During this unit of study, students will have the opportunity to develop skills in simple database design and management, design patient data collection tools and instruments such as case report form (CRFs) and demonstrate an ability to review and manage data to ensure data quality and integrity. Students will also be introduced to key statistical considerations in clinical trial study design and analysis, including hypothesis testing, determining sample size, statistical power and significance and an overview of common statistical tests used in clinical trials. Students will further develop an ability to interpret and critique data and statistics from clinical trials including how this information is translated into clinical practice.
NURS5068 Clinical Trials in Practice
Credit points: 6 Session: Semester 2 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.
NURS5069 Research in Nursing and Health Care
Credit points: 6 Session: Semester 1 Assessment: 2 x online activities (20%) and 2x assignments (80%) Campus: Mallett Street Mode of delivery: Distance Education/Intensive on Campus
This unit of study will examine and critique established and emerging ways of researching nursing and health care through discussion of the philosophical and theoretical origins of the research traditions and knowledge generation in nursing research. Conceptualisation of research questions, selection of research designs, governance of research and research utilisation in the clinical setting will be explored. Opportunities will be provided to engage in the research process with reference to clinically related situations.
NURS5092 Capstone (Clinical Trials Practice)
Credit points: 6 Session: Semester 1,Semester 2 Assessment: Reflective portfolio (40%), assignment (40%), presentation (20%) Campus: Mallett Street Mode of delivery: Distance Education/Intensive on Campus
Note: Department permission required for enrolment
In this unit of study, students will extend their professional knowledge and skills through further critical analysis of issues that affect the management, conduct and practice of clinical trials. The unit provides a framework for students to undertake one of the following options:
1. Explore specific, contemporary workplace situations relevant to clinical trials practice. These situations may range from the development of a proposal for a new clinical trial, through to the development of a plan for implementation and management of a clinical trial. In this work, students will be supported to develop their expertise in working within an ethical and regulatory framework.
2. Negotiate and participate in a period of partnered observation with appropriate senior clinical trials managers or investigators, in order to develop a personal portfolio which will incorporate the work undertaken during the degree course, including guided reflection on their observation and understanding of advanced roles in clinical trials practice.
1. Explore specific, contemporary workplace situations relevant to clinical trials practice. These situations may range from the development of a proposal for a new clinical trial, through to the development of a plan for implementation and management of a clinical trial. In this work, students will be supported to develop their expertise in working within an ethical and regulatory framework.
2. Negotiate and participate in a period of partnered observation with appropriate senior clinical trials managers or investigators, in order to develop a personal portfolio which will incorporate the work undertaken during the degree course, including guided reflection on their observation and understanding of advanced roles in clinical trials practice.
Degree resolutions
Master of Clinical Trials Practice
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 University policy on Academic Dishonesty and Plagiarism.
Course resolutions
1 Course codes
|
Code |
Course title |
|---|---|
|
GG015 |
Graduate Certificate in Clinical Trials Practice |
|
GF026 |
Graduate Diploma in Clinical Trials Practice |
|
GC068 |
Master of Clinical Trials Practice |
2 Attendance pattern
0.
The attendance pattern for this course is full time or part time according to candidate choice, except for the Graduate Certificate which is part time only.
3 Master's type
0.
The master's degree in these resolutions is an advanced learning master's course, as defined by the Coursework Rule.
4 Cross-faculty management
(1)
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.
(2)
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.
(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 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)
Admission to each course requires the applicant to satisfy the English language proficiency requirements detailed in the faculty resolutions.
(2)
Available places will be offered to qualified applicants according to the following admission criteria.
(a)
a bachelor's degree in a relevant discipline from the University of Sydney or equivalent qualification; or
(c)
In exceptional circumstances the Dean may admit applicants without this qualification who, in the opinion of the faculty, have qualifications and evidence of experience and achievement sufficient to successfully undertake the award.
(a)
a bachelor's degree in a relevant discipline from the University of Sydney or equivalent qualification; or
(b)
a Graduate Certificate in Clinical Trials Research from the University of Sydney, or equivalent qualification; or
(c)
completion of the requirements of the embedded Graduate Certificate in Clinical Trials Practice from the University of Sydney, or equivalent qualification; or.
(e)
In exceptional circumstances the Dean may admit applicants without these qualifications who, in the opinion of the faculty, have qualifications and evidence of experience and achievement sufficient to successfully undertake the award.
(a)
a bachelor's degree in a relevant discipline from the University of Sydney or equivalent qualification, with a credit average; or
(b)
a Graduate Certificate in Clinical Trials Research from the University of Sydney or equivalent qualification; or
(c)
a graduate diploma in a relevant discipline from the University of Sydney or equivalent qualification; or
(d)
completion of the requirements of the embedded Graduate Certificate or Graduate Diploma in Clinical Trials Practice without graduating from the University of Sydney, or equivalent qualification.
(6)
Qualifications used as the basis of admission must have been completed less than ten years prior to application. Qualifications older than ten years will be considered subject to the applicant providing further information substantiating appropriate continuing education and development. In these cases, admission will be at the discretion of the dean.
7 Requirements for award
(1)
The units of study that may be taken for the courses are set out in the Units of Study table for Clinical Trials Practice.
(2)
To qualify for the award of the Graduate Certificate in Clinical Trials Practice a candidate must complete 24 credit points of core units of study.
(3)
To qualify for the award of the Graduate Diploma in Clinical Trials Practice a candidate must complete 36 credit points, including:
(4)
To qualify for the award of the Master of Clinical Trials Practice a candidate must 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 Time limits
(1)
A candidate must complete all the requirements for the Graduate Certificate within two and a half calendar years of first enrolment, including periods of suspension.
(2)
A candidate must complete all the requirements for the Graduate Diploma within three calendar years of first enrolment, including periods of suspension.
(3)
A candidate must complete all the requirements for the Master's degree within four calendar years of first enrolment, including periods of suspension.
9 Credit
0.
Students in the Graduate Diploma in Clinical Trials Practice and Master of Clinical Trials Practice who have previously completed the Graduate Certificate in Clinical Trials Research, Graduate Diploma in Clinical Trials Research or Master of Clinical Trials Research will be granted 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.
10 Course transfer
0.
A candidate for the master's degree or graduate diploma may elect to discontinue study and graduate with a shorter award from this embedded sequence, with the approval of the dean, and provided the requirements of the shorter award have been met.
11 Transitional provisions
(1)
These resolutions apply to students who commenced their candidature after 1 January, 2011 and students who commenced their candidature prior to 1 January, 2011 who elect to proceed under these resolutions.
(2)
Candidates who commenced prior to 1 January, 2011 may complete the requirements in accordance with the resolutions in force at the time of their commencement, provided that requirements are completed by 1 January, 2016. The faculty may specify a later date for completion or specify alternative requirements for completion of candidatures that extend beyond this time.