NT Health Site Specific Assessment Form

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NT Health

Site Specific Assessment Form

Site Specific Assessment (SSA) is a component of institutional research governance and separate to the ethical review of research proposals by a recognised Human Research Ethics Committee (HREC). The SSA process involves assessing the suitability of the research proposal for the Health Service site and ensures that adequate resources exist for satisfactory conduct and completion of the project. The NT Research Governance Office(s) assess whether appropriate consultation and approval has been granted by local decision makers to permit the research to be undertaken at the site.

Researchers are encouraged to discuss their proposal and seek in-principle support/endorsement from the appropriate delegate/s at the Health Service, individual sites and the Research Governance Office before proceeding with developing formal ethics and SSA submissions.

The SSA application should be completed and submitted by the Site Principal Investigatorⁱ concurrently with the completion and submission of the ethics application to ensure it is reviewed in a timely manner.

INSTRUCTIONS FOR COMPLETION

Applicants are required to complete all relevant sections of this form and provide the necessary document as attachments. Applicants should state ‘not applicable’ for any sections of the form that do not apply to the proposed research.

The checklist on the back of the form has been designed to assist the applicant in ensuring a full and complete SSA package is submitted.

Once completed, the SSA form plus electronic copies of any attachments must be submitted to t he Research Governance Office (RGO) at TEHS ([email protected]) or CAHS ([email protected]) or both if the research is NT wide.

The RGO will assess the form and attached documentation and will contact the applicant if further information is required.

The Principle Investigator must receive authorisation from the RGO before the research can commence at NT Health Sites.

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1. Full Project Title

1a. Short Title

2. Brief Summary of project

3. National Health & Medical Research Council (NHMRC) Broad Research Area

☐

Basic Science

☐

Clinical Medicine and Science

☐

Health Service Research

☐

Public Health

4. NHMRC Field of Research (main relevant activity)

5. Project Type

☐

Clinical trial drug Drug Phase

☐

Clinical trial device

☐

Clinical research (includes all other clinical research and clinical trials not involving drugs / devices)

☐

Qualitative

☐

Evaluation

☐

Registry

☐

Other:

6. Site Details

☐

Single Site

☐

Multi-Site within Northern Territory only

☐

Multi-Site across Australia 7. Name of reviewing HREC/s

☐

Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research, TEHREC (EC00153)

☐

Central Australian Human Research Ethics Committee, CAHREC (EC00155)

☐

Charles Darwin University Human Research Ethics Committee (EC00154) 8. Project expected start and finish dates

Start Date Click here to enter a date.

Finish Date Click here to enter a date.

9. Research Personnel (PI = Principal Investigator, AI = Associate Investigator)

9.1 What additional time resources above their routine duties will be required of the research team throughout the research project (please add further rows for

additional AIs)

Resea rch Role

Researchers Name

(include title) Qualifications Discipline

Site

(tick) GCP certificate Research hours per week TEHS CAHS No /

Yes

Date complete

d (if yes) Paid In- kind Site

PI ☐ ☐ N☐

Y ☐ Site

AI ☐ ☐ N☐

Y ☐ Site

AI ☐ ☐ N☐

Y ☐ Site

AI ☐ ☐ N☐

Y ☐ Site

AI ☐ ☐ N☐

Y ☐

Please insert additional rows as required

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9.2 External staff (Non-NT health) that will be accessing confidential NT Health data and/or accessing NT health facilities as part of this research project. Evidence of Indemnity coverage must be provided (i.e. University or

Research Institute).

Name Role in

the research project

Employer/Organisation Please indicate access type

☐ Confidential Data

☐ Facilities ☐ Both

Please insert additional rows as required

9.3 Project Contact Person/Study Coordinator

Title

First Name Surname

Phone number Email address

10. Details of funding

(Please provide information about resources or funding that will be provided to support the research activities (eg reimbursements, per participant payment, equipment, salary).

10.1 Indicate Sponsor type

☐ Commercially Sponsored

☐ Collaborative Group, state administering Institute:

☐ Investigator Initiated Group

☐ Institution

☐ Other:

10.2 Has the research project received funding?

YES

☐

NO

☐

If no go to Q11

10.3 Type of funding source (e.g. NHMRC, Internal/Department):

10.4 Estimated funding for the Project at this site (Amount: $/year or $/participant)

$

10.5 Please refer to the fee schedule for SSA review and ensure the details below are completed prior to submission of your SSA, for billing purposes.

Name of the business ABN

Business address Billing contact name Phone number

Email

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11. NT Health Sites

(Please tick all sites that are relevant) 11.1 Top End Health Services (TEHS)

☐ Alan Walker Cancer Centre (AWCC)

☐ Gove District Hospital

☐ Katherine Hospital

☐ Royal Darwin Hospital

☐ Palmerston Regional Hospital

☐ Mental Health & Alcohol and Other Drugs Services

☐ Top End Renal Services

11.2 Top End Primary Health Care Centres (TEPHCC)

☐ Hearing Services

☐ Oral Health Services

☐ Prison Health and Police Watch House

☐ Public Health Unit

☐ Cancer Screening

☐ Remote Medical Services

☐ Community Allied Health Team and Aged Care

☐ Urban Primary Health Care Centres

☐ Remote Primary Health Care Centres Please list intended sites:

11.3 Central Australia Health Services (CAHS)

☐ Alice Springs Hospital

☐ Tennant Creek Hospital

☐ Central Australia Mental Health Service (CAMHS) and Central Australia Alcohol & Other Drugs Service (AODS).

☐ Renal Health Services

☐ Central Australia Hearing Health

11.4 Central Australia Primary Health Care Centres (CAPHCC)

☐ Central Australia Oral Health

☐ Public Health – Disease Control

☐ Public Health Environmental Health, Community Allied Health & Aged Care

☐ Alice Springs Correctional Centre

☐ Urban Primary Health Care Centres

☐ Remote Primary Health Care Centres Please list intended sites:

11.5 NT Department of Health (NT DoH)

☐ Territory Pathology (Department of Health)

☐ Other, Please Specify:

11.6 Other(s):

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12. Resources required to support research activities within NT Health Sites

Please note details of pharmacy, pathology and radiology are NOT required in this section – Please refer to sections 17,18,19

12.1 Site – Hospital Activities or

☐

Not Applicable, move to 12.2

Please state how you plan to identify potential participants:

Please state the wards at which research activities will occur:

Note: Principal Investigator should consult the Clinic Nurse Manager of the listed wards

Please state how often and for how long you expect to be working from the Hospital: Will your research require clinical equipment above that of normal care?

☐

Yes

☐

No

If yes please comment on what equipment and whether this will impact on the delivery of care to other patients:

Will ward staff be required to conduct any protocol activities?

☐

Yes

☐

No

If yes is this

☐

In-kind or

☐

paid support. Please support this with an email from the appropriate Nurse Unit Manager

Will your team be accessing an Aboriginal Liaison Officer for research

purposes?

☐

Yes

☐

No

If yes is this

☐

In-kind or

☐

paid support. Please support this with an email from the TEHS/CAHS Aboriginal Liaison Office.

Will your research require additional office or desk space?

☐

Yes

☐

No

If yes has this been negotiated and agreed upon please comment:

Note: by ticking yes does not mean this is automatically available so negotiation with the hospital delegates will be required.

Please state whether any additional support or resources will be required to conduct the project at the hospital:

12.2 Site – Primary Health Care Activities (PHC) or

☐

Not Applicable, move to 13.0 Please state how you plan to identify potential participants:

Please state how you plan to locate participants and if required bring them to the Health Service:

Will you require clinic space to see your study participants?

☐

Yes

☐

No

If yes provide details:

Will your research require use of PHC clinical equipment?

☐

Yes

☐

No

Will PHC staff be required to conduct any protocol activities?

☐

Yes

☐

No

Note: by ticking yes does not mean this is automatically available so negotiation with each clinic will be required.

Please state whether any additional support will be required to conduct the project at the local site (e.g.

loan or use of medical equipment, transport or other resources):

Note: This form will be submitted for review from PHC General Managers / Regional Managers and Clinic Managers for trials occurring on-site at PHC centres. Please contact the RGO for further information.

13. Intellectual Property

13.1 Is it likely that new Intellectual Property will be developed as a result of this project being undertaken at this site?

YES ☐ NO ☐ (if no, move to Q14)

13.2 If yes, outline the agreement stating arrangements for the use of existing and/or new intellectual property and the parties’ rights in relation to ownership?

13.3 If Intellectual Property rights will be retained by the site Principle Investigator/NT Health Service, please indicate who will be responsible for financially supporting the development of this IP should the research generate new knowledge or breakthroughs (e.g. Drug Development costs or patents) and please attach evidence

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14. Research Agreement, Indemnity & Insurance Information

14.1 Is evidence of adequate indemnity coverage for the scope of the research project attached?

YES

☐

NO

☐

N/A

☐

14.1.1 If no or N/A please given explanation:

14.1.2 If yes, please indicate what indemnity form you have provided?

☐

Medicine Australia Standard Indemnity Form or

☐

Coordinating Research Group (Administering Institution/Organisation) providing indemnity

☐

Other:

14.2 Does this trial have a research agreement?

YES

☐

NO

☐

N/A

☐

14.2.2 If yes, please indicate what type of agreement you have provided?

☐

Medicine Australia Standard Research Agreement Template or

☐

Other:

14.3 Have you provided a Certificate of Currency (CoC)?

YES

☐

NO

☐

N/A

☐

15. Participant Recruitment – Department/Service

15.1 Estimate how many patients you would see each year that would met the eligibility criteria?

15.2 Please specify the total number of participants to be recruited for this research project:

15.3 Please specify anticipated number of participants to be recruited at each site.

(Tick site/s)

☐

TEHS

☐

CAHS Number of

participants # #

Number of years

15.4 Please list the target population for this research project (eg children, Aboriginal and Torres Strait Islander Australians, other vulnerable groups):

15.5 Please indicate what methods used to screen and recruit these participants:

16. Access to Information and Data – Medical Records

16.1 What Patient Information systems do you intend to seek approval to access for research purposes.

☐

Not required

☐

Community Care Information System (CCIS)

☐

Primary Care Information System (PCIS): used by PHC

☐

Acute Care Information System (ACIS) electronic health records:

☐

Jadecare/CWS – Clinical pathology and imaging results

☐

Caresys – Patient admission, discharge, transfers and outpatients appointments.

☐

eMMa – Medicine management (medchart)

☐

synapse – Medical Imaging access (only available on NT Health computers)

☐

Hard Copy medical records – current volume and

☐

other volumes including archived

☐

Acacia: Electronic medical records (not currently active)

16.2 For external researchers, will the associated access fees for the above systems be paid for by the:

☐

Project,

☐

In-kind or

☐

No external researchers

16.3 Will health related investigation findings be documented in the participant’s health records, when relevant?

YES

☐

NO

☐

N/A

☐

16.4 How long do the study documents need to be kept?

years or

☐ N/A

16.5 Does this include hard copy medical records of participants?

years or

☐ N/A

.

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17. Investigational Drugs - Pharmacy

17.1 Will the research project include the administration of medicines?

YES

☐

NO

☐,

if no go to Q19

17.2 Is the research project being conducted under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes?

☐ N/A, add comment:

☐ CTN

☐ CTX

17.3 Please indicate what services NT Health pharmacy/ies will be providing (tick all that apply):

a

. ☐

None

b

. ☐

Procurement or

☐

Standard hospital imprest

c.

☐

Storage please list any specific requirements including temperature control:

d.

☐

Distribution

d.

☐

Dispensing:

☐

within hours and/or

☐

out of hours d.

☐

Accountability of study drug

e.

☐

Reconstitution f.

☐

Compounding

Please ensure you have consulted with the relevant pharmacy.

17.4 Will funding cover the costs of the study drug/s at the site?

YES

☐

NO

☐ if no what costs will be incurred by the site:

17.5 If a Non-NT Health Pharmacy is performing some or all of the above services please provide the name of the external organisation and details of their involvement:

17.6 Will the study drug/s be ordered by medical officer?

☐

YES,

17.6.1

☐

electronic through medchart

17.6.2

☐

paper based, please describe process

☐

NO

,

please provide comment on the process of how the study drug/s will be ordered:

If you have ticked any box in 17.3 you need to contact the RGO office ([email protected]) for contact details of the correct pharmacy. This is a governance approval requirement.

Pharmacy fees may be applicable to the research project please view the fee schedulesⁱⁱ

18. Nuclear Medicine and Radiology

18.1 Does this clinical trial require additional medical imaging above standard of care?

YES

☐

NO

☐

N/A

☐

If yes, please complete table below, please note you will require authorisation from the Head of Department.

Tests number of additional tests above standard of care per year

For how many

years Is this covered by

the study budget

MRI scans YES ☐ *NO ☐

CT scans YES ☐ *NO ☐

Ultrasound YES ☐ *NO ☐

X-ray YES ☐ *NO ☐

Fluoroscopy x- ray

YES ☐ *NO ☐

PET/SPECT

scans YES ☐ *NO ☐

Radiation Therapy

YES ☐ *NO ☐

Angiography YES ☐ *NO ☐

Other YES ☐ *NO ☐

*If No in any of the above please comments on who will cover this additional costs?

18.2 Does this trial require pulling or duplicating images? YES

☐

NO

☐

N/A

☐

(if no or n/a go to Q19)

18.3 Will you require de-identified images or images in bulk? YES

☐

NO

☐ (

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Nuclear medicine and Radiology fees may be applicable to the research project please view the fee schedules

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19. Territory Pathology – Northern Territory Department of Health 19.1 Is the pathology collection above standard of care?

YES

☐

NO

☐

N/A

☐

(If No or N/A go to Q20)

19.2 Do you have funding to cover the costs of the additional pathology requirements?

YES ☐ NO ☐

19.3 Please indicate require pathology services

☐

pathology results (data)

☐

specimen holding and storage

☐

tissue pathology, holding and storage

☐

additional services (i.e. slides/stains or histology)

☐

transport of samples

If you have ticked any box in 19.3 you need to contact the Operations Manager Territory Pathology directly for further advice, details: [email protected]. This is a governance approval requirement.

Approval by Territory Pathology is required to access test results or pathology data.

Pathology fees may be applicable to the research project, please view the fee schedules

20. Dissemination of study outcomes and Translation into Practice Plan

20.1 How will the results be disseminated/implemented to relevant Staff within the NT Health Services?

20.2 How will research results be fed back to study participants (tick if applicable)?

☐

Urban:

☐

Remote:

21. Please list Departments/Services involved in the research at this site

(Note that approval from the Head/s of Department/s or Service/s is required, an email of support should be submitted with this application, their email will be signifying that all resources and support required within their department to complete the project are available or will be made available at the site i.e. pharmacy, pathology, infectious diseases etc). Please contact the RGO for further information if required.

Where the Principal Investigator for the study is also the Head of Department, support must be sought from the person to whom the Head of Department is responsible. Investigators must not approve their own research on behalf of the Health Services.

Please insert additional rows if more Departments required

Department/Service Head of Department Email

Support Attached (Y,N)

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22. Declarations

Declaration by Site Coordinator/Principal Investigator (Please refer to Responsibilities of NT Health site Principal Investigators)

☐ I declare the information in this form is truthful and accurate to the best of my knowledge and belief and I take full responsibility at this site.

☐ I will only start this research project after obtaining authorisation from the Research Governance Office (RGO) and approval from the responsible Human Research Ethics Committee (HREC).

☐ I accept responsibility for the conduct of this research project according to the principles of the NHMRC National Statement of Ethical Conduct in Research.

☐ I undertake to conduct this research project in accordance with the protocols and

procedures as approved by the HREC and the ethical and research arrangements of the organisation(s) involved.

☐ I undertake to conduct this research in accordance with relevant legislation and regulations.

☐ I agree to comply with the requirements of adverse or unexpected event reporting as stipulated by the HREC and NHMRC.

☐ I will adhere to the conditions or approval stipulated by the HREC and RGO. I will cooperate with HREC and RGO monitoring requirements.

☐ I will inform the HREC and the RGO if the research project ceases before the expected date.

I will discontinue the research if the HREC or RGO withdraws approval.

☐ I will adhere to the conditions of authorisation stipulated by the authorising authority at the site where I am Principal Investigator. I will discontinue the research if the authorising authority withdraws authorisation at the site where I am Principal Investigator.

☐ I understand and agree that study files and documents and research records and data may be subject to inspection by the HREC, RGO, the Sponsor or an independent body for audit and monitoring purposes.

☐ I understand that information relating to this research, and about me as a researcher, will be held by the HREC and RGO. This information will be used for reporting purposes and managed according to the principles establishing in the Privacy Act 1988 (Cth) and relevant laws in the States and Territories of Australia.

Name of Principal Investigator:

Signatur e:

Date: Click or tap to enter a date.

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23. Document Submission Checklist

Person Completing

Form Office Use Only

Are the qualifications listed and GCP

certificate attached for each researcher? YES NO N/A YES NO N/A Has the PI and AIs completed a conflict of

interest form? YES NO N/A YES NO N/A

Has details for a contact person for this

project been completed? YES NO N/A YES NO N/A Has a copy of the ethics application been

provided? YES NO N/A YES NO N/A

Has a copy of the HREC approval letter

been provided? YES NO Pending YES NO

Is a copy of the protocol provided? YES NO N/A YES NO N/A Has a copy of the Investigators

Brochure/drug information/device been provided?

YES NO N/A YES NO N/A

Are Master and Site Specific Participant Information and Consent Form(s) attached and show the name of the Institution and contact details of the Principal Site

Investigator? The version number, standard organisation name and date should be in the footer.

YES NO N/A YES NO N/A

Has a copy of project advertising been

Has a copy of any questionnaires been

Has evidence of Intellectual Property

arrangements attached? YES NO N/A YES NO N/A Has a completed CTN or CTX form been

attached to this submission? YES NO N/A YES NO N/A Is the Medicines Australia Standard

Indemnity Form, or other indemnity signed by the sponsor, attached?

YES NO N/A YES NO N/A

Is evidence of adequate insurance cover

attached (certificate of currency)? YES NO N/A YES NO N/A Is a research agreement or Medicines

Australia Standard Clinical Trial Agreement attached?

All research agreements must be reviewed by the RGO and signed on behalf of DoH/TEHS/CAHS

Has evidence of biosafety approval been

Has evidence of an application for NHMRC Gene Related Therapies assessment been provided?

YES NO N/A YES NO N/A

Has evidence of radiation safety been

Have the Head/s of all participating Departments or Services involved in the study support the study (i.e. Divisional Head, Pathology, Pharmacy and

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Has the Site PI notified the Clinical Nurse Manager of wards where research

activities will occur?

YES NO N/A YES NO N/A

Has the data custodian/s provided permission to allow the study

investigator/s to use any data required for the study?

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24. Recommendation by Unit Head/Co-Director/Director of Medical Services/Director of Nursing/Director of Allied Health

The Site-Specific Assessment (SSA) form for this research project has been completed (with all attachments) and I have reviewed the following:

 There are suitable and adequate facilities and resources for the research project to be conducted at this site.

 The research is relevant to the site with TEHS and aligns with NT health and TEHS strategic goals.

 The Organisation benefit of participating in the research is consistent with the resource contribution.

 The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery.

 All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.

 All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.

 There is no conflict of interest for the researcher’s or that the declared conflict of interest is acceptable.

 There is evidence of compliance with indemnity requirements.

 Requirements for access to organisational data are clear and comply with legislative and NT Health policy requirements.

 Data management, privacy and confidentiality requirements are described, and comply with legislative requirements.

SSA authorisation is therefore:

Supported Not support

If not supported, please state reasons below:

Name:

Position:

Signature:

Date: Click or tap to enter a date.

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25. Recommendation by relevant Professional lead (EDONM/EDMS/EDAH etc.) where applicable

The Site-Specific Assessment (SSA) form for this research project has been completed (with all attachments) and have reviewed the following.

• There are suitable and adequate facilities and resources for the research project to be conducted at this site.

• The research is relevant to the site with TEHS and aligns with NT health and TEHS strategic goals.

• The Organisation benefit of participating in the research is consistent with the resource contribution.

• The research translation strategy is demonstrated and will provide evidence based information for improving patient outcomes, clinical care or service delivery.

• All external researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.

• All NT Health researchers/students involved in the research project have the skills, training and experience necessary to undertake their role.

• There is no conflict of interest for the researcher’s or that the declared conflict of interest is acceptable.

• There is evidence of compliance with indemnity requirements.

• Requirements for access to organisational data are clear and comply with legislative and NT Health policy requirements.

• Data management, privacy and confidentiality requirements are described, and comply with legislative requirements.

Supported Not support

Name:

Position:

Signature:

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26. Recommendation by Institutional Head (eg Chief Operating Officer/Executive Director/General Manager)

I have reviewed the Site-Specific Assessment form for this research project together with all attachments and have reviewed the following:

• There is a clear organisational benefit of participation in the research.

• The research is consistent with the strategic objectives of the organisation.

• The research project and resource implications are within the allocated budget of the service.

I am aware of the resource requirements of this project and have determined they are available

Yes No

Supported Not support

Name:

Position:

Signature:

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27. Final Authorisation by the Research Governance Office (Executive Director) I hereby confirm that I am (please tick relevant box):

Satisfied that the proposed research meets all research governance requirements of this site. I therefore authorise the commencement of this project.

Not satisfied with one or more components of this submission, and am therefore unable to authorise the commencement of this project and will seek further information from the site Principle Investigator.

If not authorised, please state reasons below:

Name:

Position:

Signature:

Date: Click or tap to enter a date.

OFFICE USE ONLY

Date In /

Out

Comment SSA status

(received, progressing or authorised)

i https://health.nt.gov.au/data-and-research/nt-health-research/site-principal-investigator-responsibilities

ii https://health.nt.gov.au/data-and-research/nt-health-research/fee-schedules