Office use only
Study number:
MIA2016/
CT/

If you intend to submit a clinical trial outline/research proposal/audit/student projectto be conducted at Melanoma Institute Australia, please complete this form[1]. The MIA Research Committee or Clinical Trials Managerwill review this proposal and relevant feedback will be provided as soon as possible.

Please forward all queries and the completed form to the following email:

CLINICAL TRIAL OUTLINE/RESEARCH PROPOSAL/AUDIT/STUDENT PROJECT

Name of applicant
Contact email address
Date of application
Investigators(along with their affiliations in brackets)
Please list all principal and co-investigators here.
Type of project
CLINICAL TRIAL OUTLINE/RESEARCH PROPOSAL (Please choose sponsor)
Pharmaceutical/Industry
Collaborative group
Investigator
MIA
RETROSPECTIVE STUDY/AUDIT
PROSPECTIVE STUDY/AUDIT
STUDENT PROJECT
Clinical meeting review
Friday MDT/Research meeting
Surgeons meeting
Medical oncology meeting
Not reviewed
If this project was presented during an MIA regular clinical meeting, please indicate here and attach meeting minutes or summary of the feedback. Doing so will enable expedited review of the project by the research committee.
Title
Brief background and rationale
If the study is a clinical trial, please attach and reference the clinical trial protocol where appropriate for the sections below.
Aim
Insert details here
Objectives
Insert details here
Hypotheses
Insert details here
Population and setting
Insert details here
Interventions (if applicable)
Insert details here
Outcomes and measures
Primary outcome
Insert details here
Secondary outcomes
Insert details here
Study design and procedure – outline only
Insert details here
Statistical considerations/sample size/data collection
Insert details here
Timeline
Insert details here include review dates and reporting procedures
External/Internal funding sources
Insert details here of all funding sources and relevant agreements in the event of any shortfall.
Recruitment
Insert details here
Clinical trial feasibility
Please obtain clinical trial feasibility assessment prior to submitting this research template and provide details here.
Ethics approval process
Insert details here
Proposed date of commencement
Proposed date of completion
Request for resources from the MIA Research Committee
In your opinion, which 2 of the following main discipline areas does this project best fall for internal review purposes?
Surgical Oncology
Medical Oncology
Radiation Oncology
Pathology
Dermatology
Psycho-social/Nursing/Allied Health
Epidemiology/Public Health/Biostatistics
Other ______
Please suggesta list of 3 potentials reviewers[2]
1)
2)
3)
Would you like clinical input from other MIA colleagues (not already named in the proposal) from any of the following main disciplines?
Surgical Oncologist
Medical Oncologist
Radiation Oncologist
Pathologist
Dermatologist
Psychologist/Nurse/Allied Health staff
Epidemiologist/Public Health staff/Biostatistician
Other ______
Do you wish to apply for internal funding assistance from the MIA Research Committee to conduct this study/trial?
Insert details here
Will you require project management assistance with this study/trial?
Insert details here
Will you require data collection or data management assistance during this study?
Insert details here
Will you require statistical advice or analysis conductedduring this study?
Insert details here
Will this project involve viewing patient data (i.e. access to logon facilities) held in the Melanoma Research Database (MRD)?
Insert details here
Will you require data retrieval services (i.e. data download) from the Melanoma Research Database (MRD)?
Insert details here
Any other requests for assistance
Insert details here

CONCEPT OUTLINE Template: modified with permission from the NHMRC Clinical Trials Centre OUTREACH initiativePage 1

[1] This template can be updated without notice, please make sure you are using the most recent version by contacting the MIARC secretary

[2]Potential reviewers are MIA clinicians & researchers, and clinicians & researchers collaborating with the institute with no conflict of interest and knowledgeable in this particular area of research.