45 and Up Study Project Application Form
SECTION A - APPLICATION TYPEA1. Project reference number (if known):
A2. What type of project application review do you require from the 45 and Up Study team?
(Note – a project is broadly defined as an approved data release covered by one Data Use Agreement
executed with the Sax Institute)
Review of a project proposal for STAGE 1 APPROVAL
(a rapid review of an unfunded project to obtain a feasibility statement)
Review of a project proposal for STAGE 2 APPROVAL
(a full review for a project which has funding)
A3. Do you also require an estimate of project costs as part of your project application review?
No
Yes. If you require a revised estimate, please give the previous quote reference number:
A4. Which type of data provision will your project require? (more than one type may be selected from the list below)
45 and Up Study baseline questionnaire data
45 and Up Study first follow-up questionnaire data (not yet available – expression of interest only)
Linkage of 45 and Up Study data to the Department of Human Services’ Medicare Benefits or Pharmaceutical Benefits records (held by the Sax Institute)
Linkage of 45 and Up Study data to one or more other data collections
Collection of new data by recontacting members of the 45 and Up Study cohort, i.e. a sub-study
Other, please specify:
A5. Please select the category that applies to your project.
Your project is related to another project already reviewed or approved by the 45 and Up Study
Your project is to be done under a 45 and Up Study partnership agreement
Your project will be covered in part or in full by one or more existing prepaid 45 and Up Study data licences
None of the above
If you selected any of the above application categories, please give further details (including project reference numbers where relevant)
SECTION B - LEAD INVESTIGATOR /
B1. Contact details for the Lead Investigator
Title: First Name: Last Name:
Organisation:
Position: Department:
Email: Telephone:
Postal address - include suburb, state, postcode
B2. Please provide a brief track record of the lead investigator, with special focus on experience of leading a project of this type.
SECTION C - PROJECT OVERVIEW /
C1. Please provide a title, brief summary and keywords for your project
Project title:
Please give a brief plain English summary of your project, suitable for lay people to read on our website
(max 300 characters)
Please give three plain English keywords for your project
1.
2.
3.
C2. What is your project timeline? Start date: Click here to enter a date.
Completion date (include paper write up): Click here to enter a date.
C3. What is the proposed funding source(s) for your project?
(For a Stage 2 application, please attach evidence of available funding)
C3a. If a funding application has been submitted, please indicate the funding scheme (and grant ID), the funding period, and the total funds requested (plus funds awarded if the grant was successful):
C4. Please list the research questions that your project is designed to answer.
Please write your research questions with enough detail to clearly justify all variables you will ask for at Question C5. This will include describing the population or sub-population of interest, and stating the ‘exposure’ and outcome variables, and necessary covariates.
For a Stage 2 application, please also attach the full research plan. For this purpose you may attach a research plan that formed part of successful grant application. If you need to write a research plan, it is recommended you use the format of the NHMRC project grant requirements for a ‘Detailed Background and Research Plan’.
C5. Please complete a variable checklist to request the 45 and Up Study variables needed for your research questions (C4), with a brief justification for each variable.
(Completion of this item is required for a Stage 2 application, and optional for Stage 1 application)
Please indicate below which variable request forms you have completed for the 45 and Up Study and are submitting with this application.
45 and Up Study Baseline Questionnaire Variable Checklist
45 and Up Study first Follow-up Questionnaire Variable Checklist
C6. Please outline the proposed use, value, and significance of the results of your project, especially for policy and practice
C7. How will your project findings be disseminated?
SECTION D - PROJECT PERSONNEL AND DATA ACCESS /
D1. How many researchers and research staff will require access to the 45 and Up Study unit record data and for how long?
D2. Please provide below the details of all project personnel, and their project role
[full completion of this item is optional for a Stage 1 application ]
D2.1 / Lead Investigator:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.2 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.3 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.4 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.5 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.6 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.7 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
D2.8 / Title/Name:
Organisation/Position:
Email: Telephone:
This person is a student/trainee to be supervised by*:
/ Project Role:
This person will access unit record data
*Any named supervisor must also be detailed fully in this list
If necessary, please include any additional personnel in an attachment ensuring full details are provided.
Attachment included
SECTION E - DATA LINKAGE REQUIREMENTS(If your project does not involve data linkage, please go to the next section of this form) /
Please indicate which data collections your project proposes to link to the 45 and Up Study records
E1. Department of Human Services Medicare or Pharmaceutical Benefits Records
Medicare Benefits Schedule (MBS) records (must be accessed via SURE only**)
Pharmaceutical Benefits Scheme (PBS) records (must be accessed via SURE only**)
NOTE: If you are requesting MBS or PBS records, please complete the DHS Variables Checklist and submit with this application (optional for Stage 1 but required for a Stage 2 application).
E2. Data collections that are part of the Centre for Health Record Linkage (CHeReL) Master Linkage Key
NSW Admitted Patient Data Collection
NSW Registry of Births, Deaths and Marriages - Death Registrations
ABS Deaths – Cause-coded NSW Deaths
ABS Perinatal Deaths
NSW Perinatal Data Collection (formerly Midwives Data Collection)
NSW Emergency Data Collection
NSW Central Cancer Registry
NSW Perinatal Death Review Database
NSW Notifiable Conditions Information System
NSW Mental Health Ambulatory data
ACT Admitted Patients Data Collection (Canberra Hospital)
ACT Emergency Department Information System (Canberra Hospital)
ACT Cancer Registry
ACT Perinatal Data Collection
E3. Data collections that are NOT part of the Master Linkage Key
ANZDATA - Australia and New Zealand Dialysis & Transplantation Register
Department of Health and Ageing - Residential Aged Care
Department of Health and Ageing - Australian Bleeding Disorder Register
Department of Health and Ageing - Community Aged Care Package
Department of Health and Ageing - Aged Care Assessment Team
Australian Institute of Health and Welfare - National Cancer Statistics Clearing House
Australian Institute of Health and Welfare - National Death Index
Australian Institute of Health and Welfare - National Diabetes Services Scheme
Australian Institute of Health and Welfare - Disability Information
Breast Screen NSW - NSW Breast Screening Register
Department of Veterans’ Affairs - Services Use
Department of Veterans’ Affairs - Repatriation Pharmaceutical Benefits Scheme
Department of Veterans’ Affairs - Australian Veterans' Home Care Files
Department of Veterans’ Affairs - Repatriation Hospital Data
NSW Ambulance Service - Ambulance Data
NSW Cancer Institute - Pap Test Register
NSW Health Department - NSW Radiotherapy Management Information System
NSW Health Department - NSW Brain Injury Rehabilitation Program Data Collection
NSW Health Department - NSW Community Mental Health Collection
NSW Roads and Maritime Services (formerly RTA) - NSW Health Related Road Traffic Authority Data
OTHER, please specify:
OTHER, please specify:
OTHER, please specify:
OTHER, please specify:
OTHER, please specify:
OTHER, please specify:
**If your project requires the SURE facility to access data or you wish to use the SURE facility, please contact the SURE team for information:
SURE website: www.sure.org.au
(If your project does not involve a sub-study, please go to the next section of this form.)
Stage 2 applicants must supply the funded sub-study research plan with this application (see Question C4) /
F1. Describe why the 45 and Up Study cohort is necessary for your sub-study project.
F2. How will the data collected by your project ‘add value’ to the 45 and Up Study data resource?
F3. How many 45 and Up Study participants must you have in your sub-study population?
(A Stage 2 application must specify and justify a specific sample size)
F4. What are the inclusion/exclusion criteria for 45 and Up Study participants in your sub-study?
F5. How do you propose participants will be invited to take part in your project?
(A Stage 2 application must provide a detailed recruitment protocol with a draft of the invitation materials, e.g. text of invitation)
Mail (regular post) Email Telephone Other:
F6. What is the data collection method (i.e. how will people give information) for this sub-study project?
(more than one may apply)
Paper-based / mail, e.g. questionnaire Online, e.g. survey via email
Telephone, e.g. interview Activity, e.g. focus group
Provide a biospecimen e.g. blood sample Other:
F7. Briefly describe what a participant will be asked to do and the personal investment required of them (e.g. time, physical, emotional).
(A Stage 2 application must provide detailed information, including a draft of the materials, e.g. interview proforma, survey item draft)
F8. What are the potential benefits for a participant in this sub-study project?
(A Stage 2 application must provide a draft of the relevant statement in the ethics application prior to submission)
F9. What are the potential sources of stress or distress for a participant in this sub-study project, and how will they be managed?
(A Stage 2 application must provide a draft of the relevant statement in the ethics application prior to submission)
F10. Please describe any consumer representative input into your sub-study project plan (or plans to obtain this input).
F11. Additional comments about your sub-study project proposal?
SECTION G - ETHICAL APPROVAL AND DATA SECURITY
G1. Please list all locations where the data for your project will be stored or analysed.
(This item is optional for a Stage 1 application, and must be completed for a Stage 2 application)
G2. Please list below all the ethics committees and agencies that must review and approve your project before it can commence, and the current status of your project. Please list first the primary ethics committee giving ethical oversight for the Lead Investigator.
(This item is optional for a Stage 1 application, and must be completed for a Stage 2 application)
G2.1 / Primary ethics committee for the Lead Investigator: / Status of your application to this committee/agency
Approved, please give the approval date:
Click here to enter a date.
Submitted for review and outcome pending
Not approved but revisions in process
Not yet submitted
G2.2 / Name of committee or agency:
/ Status of your application to this committee/agency
Approved, please give the approval date:
Click here to enter a date.
Submitted for review and outcome pending
Not approved but revisions in process
Not yet submitted
G2.3 / Name of committee or agency:
/ Status of your application to this committee/agency
Approved, please give the approval date:
Click here to enter a date.
Submitted for review and outcome pending
Not approved but revisions in process
Not yet submitted
G2.4 / Name of committee or agency:
/ Status of your application to this committee/agency
Approved, please give the approval date:
Click here to enter a date.
Submitted for review and outcome pending
Not approved but revisions in process
Not yet submitted
G2.5 / Name of committee or agency: / Status of your application to this committee/agency
Approved, please give the approval date:
Click here to enter a date.
Submitted for review and outcome pending
Not approved but revisions in process
Not yet submitted
G2.6 / Name of committee or agency: / Status of your application to this committee/agency
Approved, please give the approval date:
Click here to enter a date.
Submitted for review and outcome pending
Not approved but revisions in process
Not yet submitted
H. DECLARATIONS
H1. Principles of data access and data use
In submitting this application form, the Lead Investigator (named in Section B) acknowledges the following principles of data use:
· the Research Organisation of primary affiliation to the Lead Researcher will execute a Data Use Agreement with the Sax Institute before the project is given access to the 45 and Up Study data;
· each of the named personnel on your project must sign a 45 and Up Study Individual Confidentiality Agreement;
· a project must be conducted in accordance with all the relevant policies of the 45 and Up Study;
· data security practices will be maintained in accordance with the declarations made to the relevant ethics committees and the principles outlined in the 45 and Up Study Individual Confidentiality Agreement;
· for projects collecting data in a sub-study, the intellectual property rights will vest in the Research Organisation; and the Research Organisation must licence the Sax Institute to allow third parties to use the data collected in a sub-study after a negotiated period of exclusive use (as per the signed Data Use Agreement);
· for projects accessing linked data, the Sax Institute makes no guarantees in relation to approvals from data custodians for other data sets that may be required for linkage to the 45 and Up Study data collection;
· prior to their submission for publication, manuscripts and reports from your project will be submitted for technical review to the Sax Institute and, where relevant, one or both of the following agencies: the Department of Human Services (for reports of Medicare Australia data) and the Aboriginal Health and Medical Research Council (for reports of Aboriginal and Torres Strait Islander data).
DECLARATIONS
Please check this box to indicate that the Lead Investigator is aware of, and is willing to abide by, the data access and use principles as outlined above.
Please check this box if the Lead Investigator is a student or a trainee to verify that his/her supervisor, as named in Section D of this form, has reviewed and approved this completed application form prior to submission.
Application checklist