Participating Site Operational Approval Form

To obtain governance approval from SJGHC, please follow these steps:

1.     Discuss the proposed study with the Participating Site
2.     Complete this form (certain questions will appear depending on answers provided)
3.     Click Save and Complete Later link to save your progress at any time
4. Submit the form once complete
5. A PDF copy will be automatically emailed to you to obtain signatures in accordance with the process of the Participating Site

Please contact karen.roberts@sjog.org.au if you have any questions about this form.

Your Name *

Your Email Address *

Your Role *

Your Contact Number *

Version of Form *Please do not select "Final" until all stakeholders have reviewed this form and no further amendments are necessary

I confirm that this study has a completed
Research Protocol/Project Description. *

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General Information

Full Title

Short Title/Acronym(35 characters max)

Private Rooms

External Site/s

What type of research is this study?

What type of data collection will the study use?

ProspectiveRetrospectiveBoth prospective and retrospective

A "clinical trial" is defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

According to this definition, is this study a clinical trial? *

YesNo

What is the Clinical Trials Registry and Trial Registration Number for this study?

As per Section 3.1.7 of the National Statement, clinical trials must be registered in a publicly available registry before the first participant is recruited. However, it is strongly recommended that observational research is also registered in a publicly available registry in the interests of research transparency and translation of results.

Registry Name

Registration Number

Registration In Progress

Not registered

Anticipated Start Date

Anticipated Completion DateRefers to conclusion of data analysis/final write up of results

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Services and Resources

Number of Areas where Access is Requiredi.e. Number of services, departments, wards or units where study participants or data will be accessed

Name of Area Where Access is Required

Name of Areas Where Access is Required

Please complete the Pathology Service section of this form for where the biospecimens are located

What patient type of biospecimens are you requesting access to?e.g. Patients who received Treatment X at Hospital Y between Date A and Date B

What biospecimens do you want to collect?e.g. FFPE tumour tissue blocks

Requesting access to biospecimens until?

Other Services to be Utilised for the Study

Radiology Services

Pharmacy

Pathology

Cardiology

Health Records

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Key Roles

Who is responsible for initiating this study?

Who is the study sponsor?i.e. Who is responsible for initiating the trial?

If different, who is the Australian-based study sponsor?

Is a Clinical Research Organisation (CRO) involved with this study?

YesNo

Name of CRO

Who is the Coordinating Principal Investigator (CPI)?

The CPI has overall responsibility for the research study.

CPI Name

CPI Affiliation

As this is a student project, please enter the primary supervisor as the Principal Investigator and the student as a Co-Investigator below

Who is the Principal Investigator (PI) at the Participating Site/s? (Please add a line for the PI at each Participating Site)

The PI takes responsibility at their own site for the conduct, management, monitoring and reporting of the research.

Principal Investigator Name

Participating Site

SJGHC Employee/VMO/JMO?

YesNo

SJGHC staff member that PI is to liaise with for study implementation at site

Who are the Co-investigators at the Participating Site/s? (Please add a line for each Co-Investigator)

Co-Investigator Name

Affiliation

What training and experience do the Participating Site Investigators have that is specific to the intervention under investigation in this early phase/pilot trial?Please attach any supporting documentation, including endorsement from the Participating Site (e.g. letter from Credentialing Committee)

Are all study personnel up to date with GCP training?

YesNo

Please attach evidence of current GCP training and current CVs of study personnel to this form

Please consult this site. GCP training for all study personnel must be completed prior to recruitment of the first patient

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Study Summary

Why is this study worth doing?Please give a brief literature review or explanation of the background, and describe the importance of this study

What does this study aim to achieve?Please detail all aims, hypotheses, objectives and research questions of the study

What participants will be recruited into this study?

PatientsCaregiversOther

What are the inclusion/exclusion criteria?

How will the study be carried out?Please give a brief explanation of the protocol or study methodology

Will the study involve participants who are under 18 years of age?

YesNo

Please attach current Working with Children's Checks for all relevant study personnel

Will the study involve patients who lack the capacity to provide informed consent?

YesNo

How will consent be sought from the "research decision-maker" as per the requirements of the Guardianship and Administration Amendment (Medical Research) Act 2020?

If the study constitutes a clinical trial as defined in the Guardianship Act 1997 NSW (GA) and involves the carrying out of medical or dental treatment, this must be submitted to the NSW Tribunal for approval. What was the outcome of this submission to the NSW Tribunal?

Describe how the study includes appropriate documentation to enable the person responsible to consider a request to provide consent and to give that consent. (In the case of a clinical trial, this will be in writing.)

Is there a possibility of significant new Intellectual Property being developed from this study?

YesNo

Please provide details of legal agreement stating arrangements for the use of existing Intellectual Property and the party's rights in relation to ownership

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Stakeholder and Consumer Endorsement

What "multidisciplinary endorsement" does the study have?Endorsement from peers, e.g. SJGHC Participating Site Clinical Head of Department and Clinical Nurse Manager, as well as other key stakeholders, e.g. General Practitioners of the value of the research

How is consumer/community involvement and engagement contributing to the design and conduct of this study?Consumers can be defined as potential study participants, carers, and people who use health care services, or people who represent the views and interests of a consumer organisation, a community or a wider constituency. Consumers should be involved in setting the research agenda and/or prioritisation, ongoing input into study design and implementation of study results. For commercial clinical trials, please ask the Sponsor for a response to this question.

See this resource for more information about consumer engagement and involvement.

Has this study received endorsement from all relevant SJG governance committees?

YesN/AIn Progress

This relates to any non-research committee that will need to be informed of the research project, e.g. the Forms Standardisation Committee or a Consumer Representative Group.

Please provide details of endorsement including the name of the committee

How does this study fulfill and abide by the SJGHC Mission and Values?

SJGHC has an overall strategic focus on research. How does this study align with the SJGHC Participating Site/s strategic research priorities and objectives?

What are potential benefits for the Participating Site/s from participating in this study?

How do the aims of this study link to any existing standards or best practice guidelines?

NSQHS Std 1: Clinical GovernanceNSQHS Std 2: Partnering with ConsumersNSQHS Std 3: Healthcare-Associated InfectionNSQHS Std 4: Medication SafetyNSQHS Std 5: Comprehensive CareNSQHS Std 6: Communicating for SafetyNSQHS Std 7: Blood ManagementNSQHS Std 8: Recognising and Responding to Acute DeteriorationOther Standard/Guideline

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Adequate Resources

Please provide details of funding source/s and amount/s

What is the total funding amount that has been secured for the study overall, and for the Participating Site(s) individually (if different?)

Should there be a funding shortfall, what is the plan to address this?

What in-kind support will the study receive?i.e. any support or resources other than cash payment, such as staff time, use of facilities or equipment, etc.

Total expected number of hours of in-kind support dedicated to the study procedures (not part of normal work schedule)

Hourly rate ($) for in-kind support

Have the financial and in-kind support arrangements for this study been agreed upon by all relevant departments/services involved in this study?

YesNoIn Progress

You cannot submit this form until the financial and in-kind support arrangements have been agreed upon by all relevant departments/services involved in this study.

How does the study intend to make use of SJGHC premises and/or equipment that would not otherwise routinely be used?

How will this study involve SJGHC caregivers or staff outside the scope of their normal role?

What training is required for SJGHC caregivers/staff to enable their participation in the study, and how will this be provided?

What access arrangements have been made for any research personnel who are not currently accredited with or employees of SJGHC?

Does this study require a contract, access agreement and/or other legal agreement?

Yes - CompleteYes - In ProgressN/A

Please refer to the SJGHC Research Handbook for legal guidelines and proformas if required

Please attach fully executed contract/agreement to submission

Please send fully executed contract/agreement to SJGHC Ethics Office once received

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Recruitment

Anticipated Recruitment Number / Data Sample Size

Participating Site

What is the anticipated total study recruitment or total data sample size?

What is the total number of Australian sites?

Please briefly describe the recruitment/data collection process.i.e. who, what, where, when, how?

What assistance is being sought from the Participating Site/s in the recruitment of study participants?

If this study will compete for recruitment with other research on site, how will this be addressed?

Contact Person

Who is the delegated contact person for this study?

(If the study will be conducted by an external researcher, who is the contact person at the Participating Site?)

Name

Role

Phone

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Hospital Health Record and Data Access/Review

You have indicated that no health records or health data will be accessed in this study.

If this is not correct, please go back to the Services and Resources section on page 3 of this form and check the box for "Health Records".

Service/Department Name

Where will the data for this study be sourced from?e.g. Patient Health Information Department, WebPAS, other data sources

What dates will health record/other data access be required for this study?

From

What is the estimated number of health records to be accessed/reviewed for this study from this location?

Please note that retrieval of health records may incur a cost/fee, and there may be a limit to the number of records that can be retrieved/reviewed at any one time.

What is the date range of the records/data being accessed?e.g. all patients admitted for bariatric surgery between 2009 and 2019

What data items will be collected for this study?e.g. patient age, comorbidities

What other resource implications pertaining to this study are anticipated for the Patient Health Information Service at this Participating Site?

Who will be accessing the health records/other data for this study?

Please note that all review of hard copy health records is to be conducted within the Patient Health Information Department and no records may be removed without the express approval of the Director/CEO.

Please also be advised that persons who are not SJGHC caregivers or accredited with SJGHC, including students, may not be able to access patient identifiable health records at SJGHC. Please contact the research.governance@sjog.org.au for more information.

Name

Institutional Affiliation

SJG Caregiver/Accredited VMO?

YesNo

Please ensure any non-SJG caregiver completes a Privacy Declaration form and submit this to the SJGHC Ethics Office

Is a waiver of consent being sought for this study?

YesNo

Please provide a copy of the ethics and final approval letters
to the Patient Health Information Department before
commencing the study

Any further details

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Health Record and Data Access/Review

If this study will involve access to patient data from more than one source (e.g. two private consulting rooms), please complete this section for the first data source only. Then select "Other Data" checkbox in the Services and Resources section of this form to add additional sources of data as required.

Where will the data for this study be sourced from?e.g. Private consulting room electronic medical records, other data sources

What dates will health record/other data access be required for this study?

From

What is the estimated number of health records to be accessed/reviewed for this study from this location?

What is the date range of the records/data being accessed?e.g. all patients admitted for bariatric surgery between 2009 and 2019

What data items will be collected for this study?e.g. patient age, comorbidities

Who will be accessing the health records/other data for this study?

Name

Institutional Affiliation

Any further details

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

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Radiology and Nuclear Medicine

You have indicated that no Radiology or Nuclear Medicine department will be accessed in this study.

If this is not correct, please go back to the Services and Resources section on page 3 of this form and check the box for "Radiology".

Service/Department Name

Will the study involve any trial-related imaging?

YesNo

Scan Type

Number of Scans

Estimated Number of Patients

Will the study require access to radiological scans or records?

YesNo

Estimated number of scans/records

Estimated period of time for which access to scans/records is required

I have been notified of the resource implications for this study and the financial arrangements pertaining to radiology/nuclear medicine have been agreed upon with the researcher. I approve of this study being carried out using such resources as per the financial agreement for this study.

Name

Position

Signature

Date

Will the study involve the use of ionizing radiation?

YesNo

(i.e. any form of x-ray or radioisotope use, any novel uses of radiation such as a new radiopharmaceutical or new radiology imaging device, or any radiation therapy)

Please refer to the "Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes" (Australian Radiation Protection and Nuclear Safety Agency, 2005)

Please attach a Frequency of Radiological Imaging Form which has been completed by the Sponsor or their representative.

Does the PI regard the exposure of ionizing radiation in this study as additional to standard of care?

YesNo

Standard of care is the level of exposure participants would still receive if they were not part of the study.

I confirm that the level of radiological exposure required by the study protocol is not additional to routine standard of care. I have weighed the risks and benefits of the radiation exposure in this study and participants will be informed of this in the Participant Information and Consent Form.

Name

Position

Signature

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Date

Has a Radiation Dosimetry Assessment Report been completed?

YesNo

Please attach the Radiation Dosimetry Assessment Report from an Independent Medical Physicist to this form

Please complete the Radiation Dosimetry Questionnaire and forward to an Independent Medical Physicist to obtain a Radiation Dosimetry Assessment Report. The Dosimetry Report should then be forwarded to the SJGHC Ethics Office.

Was Radiological Council Approval required?

YesNo

Please note that research involving therapeutic radiation procedures may not be required to be submitted to the Radiological Council for approval.

Please attach the Radiological Council documentation to this form

Pharmacy

You have indicated that no pharmacy resources will be accessed in this study.

If this is not correct, please go back to the Services and Resources section on page 3 of this form and check the box for "Pharmacy".

Service/Department Name

What is the name of the study drug(s)?

How will the study drug(s) be supplied?

If applicable, what is the name and address of the study sponsor supplying the study drug(s)?

Will the study drug(s) be supplied for the duration of the study?

YesNo

What drugs other than the study drugs will be administered as part of the study?

What other resources pertaining to the study will be requested from this Pharmacy service?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources. Any drug(s) required for this study will be dispensed, stored and labelled according to the most recent approved version of the study protocol.

Name

Position

Signature

Date

Pathology

You have indicated that no pathology resources will be accessed in this study.

If this is not correct, please go back to the Services and Resources section on page 3 of this form and check the box for "Pathology".

Service/Department Name

Some of these additional pathology tests may incur additional costs/fees. If blood or tissue collection occurs offsite or at an alternative Pathology provider, there may be additional fees involved. If transfer of specimens is anticipated, this may require a Material Transfer Agreement (MTA).

Please give specific details regarding the pathology resources that will be required

Are the pathology resources required by the study within the scope of routine services delivered by the pathology provider to SJGHC?

YesNo

This section of the PSOA can be signed by the Site Research Operations Manager

This section of the PSOA must be signed by a representative of the Pathology Provider

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Cardiology

You have indicated that no cardiology resources will be accessed in this study.

If this is not correct, please go back to the Services and Resources section on page 3 of this form and check the box for "Cardiology".

Please note that cardiological processes which include either radiology or nuclear medicine (e.g. PET, thallium or MUGA scans) MUST be reported in the Radiology and Nuclear Medicine section of this form. Please ensure that Radiology Services has been checked on this form in order for that section to be made visible.

Service/Department Name

What cardiology procedures are anticipated for this study?

Procedure

Number of Procedures

Number of Patients

What other resource implications or other implications pertaining to this study are anticipated for this cardiology service/department?

Any further details

I have been notified of the resource implications for my department and approve of the study being carried out using such resources.

Name

Position

Signature

Date

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Other Department

You have indicated that no other services, departments, wards or units will be accessed in this study.

If this is not correct, please go back to the Services and Resources section on page 3 of this form and check the appropriate box under "Access to Resources Required for the Study".

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 2

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 3

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 4

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 5

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 6

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 7

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

Other Department 8

Service/Department/Ward/Unit Name

What resource implications or other implications pertaining to this study are anticipated for this service/department?

I have been notified of the resource implications for my department and approve of this study being carried out using such resources.

Name

Position

Signature

Date

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Save Progress

Once this form has been submitted, it can no longer be changed.
Please click "Save and Complete Later" each time you would like to save your progress so you can continue editing it later.

I have saved my progress by clicking the "Save and Complete Later" link. *

Save and Complete Later Link *

Attach documentation relevant to this form here

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Participating Site PI / CPI Responsibilities

I have read the "Australian Code for Responsible Conduct of Research" (latest edition) ("the Code") and declare that I and all persons under my supervision involved in this study agree to comply with all of the various laws, regulations, guidelines and codes of practice governing the conduct of research in Australia, and to abide by the responsibilities of researchers as outlined in the Code to:

maintain high standards of responsible research,
publicise and disseminate research findings responsibly,
respect human research participants, animals, the wider community and the environment when conducting research, and
report any research misconduct

I agree to abide by all conditions of ethics approval in accordance with NHMRC guidelines, fulfilling my responsibilities as Principal Investigator to do the following:

Notify the SJGHC HREC of any adverse events or unexpected outcomes that may affect the continuing ethical acceptability of the study
Submit any proposed amendments to previously-approved documents to SJGHC HREC for approval
Submit an annual progress report to the SJGHC HREC and the Participating Site for the duration of the study, which is due on the anniversary of ethics approval
If applicable, report all protocol deviations and serious breaches to the SJGHC HREC
Notify the SJGHC HREC and Participating Site of reason if the study ceases prior to expected date of completion
Upon completion of the study, submit a final report and translation of results to SJGHC HREC and the Participating Site

I certify that having referred to the SJGHC Clinical Trial Agreements-Legal and Insurance Guidelines (in the SJGHC Research Handbook: latest edition), any indemnity, insurance and other legal contract requirements for the study, have been or will be reviewed and approved by SJGHC Legal Services prior to the commencement of the study.

I declare that I and all persons under my supervision involved in this study agree to comply with SJGHC legal requirements and contractual arrangements as set out in the study Clinical Trial Agreement(s) (where applicable).

PI / CPI Name

PI / CPI Email AddressA PDF copy of the Final version of this form will be automatically sent to this email address

PI / CPI Signature

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Date

Participating Site Approval

I agree it is feasible to conduct this study at this site:

This study has an approved budget supported by adequate funding and/or in-kind support.
This site has the capacity to participate in the study.
I approve of this study being carried out at this site.

(SJGHC sites only)

This study fulfils and abides by the SJGHC Mission and Values.
This study aligns with the SJGHC Participating Site Strategic Research Priorities and objectives.

CEO/Delegate Name

Position Title

Signature

Date

Save and Complete Later

Participating Site Operational Approval Form Version 2.1 dated March 2024