45 and Up Project Amendment Form - Sax Institute · 2020-03-02 · 45 and Up Project Amendment Form Please complete this Project Amendment Form if you wish to: Change Chief Investigator

45 and Up Project Amendment Form Please complete this Project Amendment Form if you wish to:

Change Chief Investigator Add researchers (if you wish to remove researchers from a project, the Chief Investigator can inform us in writing via

email) Notify us of protocol amendment Request for new or update existing datasets Extend a project

Sections of the Form

1. Project Information: this is a mandatory section about the project and type of amendment.2. Amendment – Change Chief Investigator: complete this section if you are changing the Chief Investigator on the

project.3. Amendment – Add Researchers: complete this section if you are adding researchers on the project.4. Amendment – Protocol Changes: complete this section if the protocol for the project has changed.5. Amendment – Request/Update Datasets: complete this section if you wish to request for new or update existing

datasets.6. Variable Checklists: complete this section if you are requesting for datasets.7. Declaration: this is a mandatory section and must be signed by the Chief Investigator in order to process the

amendment request.

Instructions

To inform us of an amendment, please complete: ‐ Section 1 about your project; ‐ The sections that are relevant to the change you wish to make (i.e. Sections 2 to 6); and ‐ Section 7 to sign-off on the amendments.

Some amendments require evidence of ethics approval; please see Section 1 for more information.

For more information Any additional information can be found on our website or by contacting us directly: Website: https://www.saxinstitute.org.au/our-work/45-up-study/ 45 and Up Study Coordinating Centre: [email protected] Phone: 02 9188 9500

How to submit To submit this form, please click on the Submit button below.

Glossary Term Definition Chief Investigator This is the primary Chief Investigator on the Study in accordance with Ethics

approval. The Chief Investigator has overall responsibility for the project and has the authority to sign-off on instructions regarding the project with 45 and Up Study.

Curator A named individual nominated by the Chief Investigator responsible for curating (reviewing and approving) all incoming and outgoing data flow and files on the SURE Workspace. The Curator is also responsible for ensuring that any information entering the Workspace complies with Ethics and Data Custodian approvals.

Contact Person A nominated individual to interact with 45 and Up Study regarding the project. The contact person may provide instructions regarding the project with sign-off from the Chief Investigator.

Researcher Any investigator who will be accessing and/or analysing data from the 45 and Up Study as part of the research project.

1. Project InformationAll fields are mandatory in this section

Project Information 

Project ID:

SURENAME (if applicable):

Project Title (in full):

Lead organisation:

Chief Investigator:

Contact Person

If you wish to nominate a contact person for this report, please provide the following details.

Full Name:

Organisation:

Contact Number:

Email:

Reason for Amendment

Please select reason for amendment: Adding researchers Change Chief Investigator SURE workspace changes Data update / New linkages Protocol amendment Project extension. Please specify anticipated completion date: Other. Please specify:

Please provide documentation of ethics approval for these amendments.

2. Amendment – Change Chief InvestigatorChange of Chief Investigator

Name of new Chief Investigator:

Organisation:

ABN:

Email:

Contact Number:

3. Researcher informationPlease complete the following table with information about all the Researchers on this Project

Name of Researcher

Institution and Department

Position Email Contact Number

Will this researcher be

accessing data?**

You may use the CI’s details by marking ‘as per CI’ **For all researchers that have ticked ‘Yes’ to data access, Section 3.1 must also be completed.

3.1 Researchers Requiring Data Access Please complete a form for each researcher requiring data access.

Full Name and Title

Position

Is the researcher Early Career Researcher PhD student Master student Other student

Please complete the following: Supervisor and Organisation: Area of study: Funding source: Type of post:

Position on research study

Postal Address*

Mobile number Required for one time password and soft token authentication for SURE access Will this researcher be curating the SURE workspace? Is the researcher registered as part of another SURE project? SURE Virtual Machine type More info can be found at: https://www.saxinstitute.org.au/our-work/sure/using-sure/

Standard (with SAS, Stata or SPSS) Standard (without SAS, Stata or SPSS) Power (with SAS, Stata or SPSS) Power (without SAS, Stata or SPSS) Supervisory

Statistical analysis software requirements: Optional software available is listed athttp://www.saxinstitute.org.au/our-work/sure/frequently-asked-questions/ 

Other information

*To use CI’s details, note ‘as per CI’

4. Amendment – Protocol Changes Complete this section if the research protocol has changed. Please supply a copy of the updated protocol (marked up and clean versions) with this form. Reason for protocol amendment

Brief summary of protocol amendment              

5. Request/Update Datasets Please complete this section if you wish to request new datasets/variables, or updates to existing datasets. If you wish to request additional datasets and/or additional variables in existing datasets, please also complete the relevant variable checklist.  45 and Up Study Questionnaires

Update Request New Baseline (2006-2009) SEEF (2010) Follow-up (2012-2015) Follow-up (2018- 2021) Go to Section 6.1 to select dataset variables

45 and Up Study Additional Linkages

Update Request New Medicare Benefits Schedule (MBS) Pharmaceutical Benefit Scheme (PBS) Geocoded data (For each questionnaire dataset received) Go to Section 6.2 for MBS and 6.3 for PBS to select dataset variables

CHeReL Linkages (Please provide CHeRel Checklist along with this form and refer to http://www.cherel.org.au/ for more information and relevant costs payable directly to CHeReL)

Update Request New Admitted Patients Data Collection (APDC) Emergency Department Data Collection (EDDC) Central Death Registry RBDM Death Registrations Notifiable Conditions Information Management System Cause of Death Unit Record File Mental Health Ambulatory Data Collection NSW Pap Test Registry NSW Ambulance BreastScreen NSW

Other Datasets - Please specify other datasets ⃣ Update ⃣ Request New

6. Variable Checklists6.1 45 and Up Study Variable Checklist

Please complete this section if you have selected the following datasets: 45 and Up Study Baseline (2006-2009) Social, Economic and Environmental Factors (SEEF - 2010) questionnaires Follow-up (2012-2015) Follow-up (2018-2021)

Please include a brief written justification for each group of questionnaire items requested. For medical conditions, choose either by topic groups (e.g. family histories, medical conditions, treatments and operations) or by disease groups (e.g. cancers, CVD, Parkinson ’s disease, musculoskeletal diseases, precursors for CVD and diabetes, mental health and respiratory diseases).

Access the questionnaires, data dictionaries and questions in each item group by clicking on the text.

Select dataset format: SAS SPSS Stata

Variable Group Justification

Age and gender

Broad level Geography#

Qualification and Employment

Cultural Background (baseline only)

Relationships

Health Cover

Aboriginality^ (baseline only)

Household

Housing Details

Height, Weight & BMI

Smoking & Alcohol

Physical Activity / Inactivity

Diet / Nutrition

Fertility

Psychological Health

Personal Care

Carer

Variable Group Justification Self-rated Health Physical Functioning Pain (SEEF & follow-up only) Injuries & Falls Sun Protection Behaviour (baseline and follow-up only) Social Support Religion/Beliefs (SEEF only) Retirement Health Service Access (SEEF only) Managing Own Health Care (SEEF only) Cancer Screening Neighbourhood (SEEF only) Drinking Water (SEEF only) Vaccination (follow-up only) Transportation (SEEF and follow-up only) Blood Donor/Transfusion (follow-up only) Family Histories (follow-up only) Hormone Therapy Medical Conditions Overall Treatments Overall Operations Overall Medications Cancers Cardiovascular Disease Diabetes Parkinson’s Disease Musculoskeletal Precursors for CVD Mental Health

Variable Group Justification Respiratory Diseases Additional variables not routinely collected Please list: If you wish to add any variables that are not routinely collected, please contact the 45 and Up Coordinating Centre. ~ Includes geography variables at SA2 level and higher. For geography at SA1 and below, please contact the 45 and Up Coordinating Centre. ^ Additional ethics approval is required when Aboriginality used as the focus of research and/or any results will be presented by Aboriginality. However, additional Ethics approval is not required when the Aboriginality variable is to be used only as a predictor to adjust models.

Further information on 45 and Up Study Questionnaire Variables can be found at https://www.saxinstitute.org.au/wp-content/uploads/45-and-Up-Study-Questionnaire-Variables.pdf

6.2 MBS Variable Checklist

Please complete this section if you have selected the MBS datasets.

Please consult the data dictionary for more information about the MBS and PBS items https://www.saxinstitute.org.au/wp-content/uploads/MBS-Data-Dictionary-January-2017.pdf

Variable Justification

Date of Service

Date of Processing

MBS Item Description

MBS Item Number

Provider Charge

Schedule Fee

Benefit Paid

Patient Out of Pocket

Bill Type

Scrambled Rendering Provider Number

Scrambled Ordering Provider Number

Date of Referral

Hospital Indicator

Provider Specialty

Item Category

Rendering Provider Postcode

Ordering Provider Postcode

6.3 PBS Variable Checklist

Please complete this section if you have selected the PBS datasets.

Please consult the data dictionary for more information about the MBS and PBS items https://www.saxinstitute.org.au/wp-content/uploads/PBS-Data-Dictionary-January-2017.pdf

Variable Justification

Date of Supply

Date of Prescribing

PBS Item Code

PBS Item Description

Patient Category

Patient Contribution

Net Benefit

Scrambled Prescriber Number

Form Category

Gross Price

Prescriber Specialty

Quantity Supplied

ATC Code

Pharmacy Postcode

7. DeclarationThis is a mandatory section.

Signature of Chief Investigator

_________________________________________________ __________________________________ Signature Date

Signature of Exiting Chief Investigator (required only for Changing Chief Investigator)

_________________________________________________ __________________________________ Signature Date

Please sign by drawing or inserting an image of your signature

Please sign by drawing or inserting an image of your signature