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.

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

PSOA Form          Page 2 of 12

General Information

(35 characters max)

Please change your answer above from "External site/s only" to "Private rooms only".  If the Private rooms are affiliated with or situated at  a SJG hospital or service, please change your answer above to "Both SJGHC and Private rooms only", as this form will need to be approved by the Research Governance Committee at the SJG hospital.

This field is only for external sites where SJGHC is responsible for ethical review. There is no requirement to list all other external sites involved in this study

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.

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.

Refers to conclusion of data analysis/final write up of results

PSOA Form          Page 3 of 12

Services and Resources

i.e. Number of services, departments, wards or units where study participants or data will be accessed


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

e.g. Patients who received Treatment X at Hospital Y between Date A and Date B
e.g. FFPE tumour tissue blocks

PSOA Form          Page 4 of 12

Key Roles

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

The CPI has overall responsibility for the research study.


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

(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.

  (Please add a line for each Co-Investigator)

Please attach any supporting documentation, including endorsement from the Participating Site (e.g. letter from Credentialing Committee)

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

PSOA Form          Page 5 of 12

Study Summary

Please give a brief literature review or explanation of the background, and describe the importance of this study
Please detail all aims, hypotheses, objectives and research questions of the study
Please give a brief explanation of the protocol or study methodology

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

PSOA Form          Page 6 of 12

Stakeholder and Consumer Endorsement

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
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.

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.

PSOA Form          Page 7 of 12

Adequate Resources

Please provide details of funding source/s and amount/s
i.e. any support or resources other than cash payment, such as staff time, use of facilities or equipment, etc.

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.

Please refer to the SJGHC Research Handbook for legal guidelines and proformas if required. Please note, if your study will involve the transfer of data outside of SJGHC, a legal review will be required

Please attach fully executed contract/agreement to submission

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

PSOA Form          Page 8 of 12

Recruitment

i.e. who, what, where, when, how?

Contact Person

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

PSOA Form          Page 9 of 12

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".

e.g. Patient Health Information Department, WebPAS, other data sources

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.

e.g. all patients admitted for bariatric surgery between 2009 and 2019
e.g. patient age, comorbidities

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.

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

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

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

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.

e.g. Private consulting room electronic medical records, other data sources

e.g. all patients admitted for bariatric surgery between 2009 and 2019
e.g. patient age, comorbidities

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

PSOA Form:          Page 10 of 12

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".

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.

(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.

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.

Draw signature|Type signatureClear

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.

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".

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.

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".

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).

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.

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.

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

PSOA Form:          Page 11 of 12

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".

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

Other Department 2

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

Other Department 3

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

Other Department 4

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

Other Department 5

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

Other Department 6

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

Other Department 7

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

Other Department 8

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

PSOA Form:          Page 12 of 12

Save Progress

Once you click "Submit", this form will be saved in PDF format and your responses can no longer be changed. 
Click the "Save and Complete Later" link EACH TIME you want to save your progress. 
Paste the most recently generated "Save and Complete Later" URL link in the box below so that you can return to it later.

According to your previous responses, this form will be submitted to more than one SJGHC site for approval.
Click the "Save and Complete Later" link EACH TIME you want to save your progress and paste the most recent link in the text box below.
You can use this link to return and edit your previous responses so that the form can be submitted to another SJGHC site.
Once you click "Submit", this form will be saved in PDF format and your responses can no longer be changed.


Browse

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).

A PDF copy of the Final version of this form will be automatically sent to this email address
Draw signature|Type signatureClear

Participating Site Approval


  • 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. 

Save and Complete Later

Participating Site Operational Approval Form Version 2.6 dated October 2024