chris o'brien lifehouse | treating people, not just cancer · web viewa copy of the completed and...

Project Title (in full):

Site-Specific Assessment (SSA) Form

The SSA is a component of research governance and involves assessment of the suitability of the site and the Investigator(s) for the proposed research.

· This form must be completed by the Principal Investigator responsible for the research project at this site.

· The completed form must be forwarded to the Chris O’Brien Lifehouse Research Governance Manager

1. Project details

Project Title (in full as listed on the HREC approval letter):

[Title]

Name/ID of HREC reviewing the research project:

Click or tap here to enter text.

Type of project:Choose an item.

Sponsor of project: Choose an item.

2. Research Personnel (involved in the project at Chris O’Brien Lifehouse only)

Principal Investigator / Contact Person (must be an employee or VMO)

Name of Principal Investigator:

Address:

Position:

Department:

Qualifications:

Phone number: Email:

Experience & Role in research project:

Associate Investigator 1.

Full name: Associate Investigator 1

Address:

Position:

Department:

Qualifications:

Phone number:Email:




Address:

Position:

Department:

Qualifications:





Address:

Position:

Department:

Qualifications:





Address:

Position:

Department:

Qualifications:





Address:

Position:

Department:

Qualifications:



Additional investigators: NO☐YES ☐

If YES more than 5 associate investigators are involved in the study please complete the “Additional Associate Investigators for SSA” form and submit with the application.

3. Project Duration

Start Date:Click or tap to enter a date.

End Date:Click or tap to enter a date.

Recruitment period: Click or tap here to enter text.

Duration of patient follow-up period: Click or tap here to enter text.

4. Training

Will all researchers and personnel listed on the Delegation Log receive training on the study protocol and study procedures applicable to their role in the project?

Yes ☐No ☐

Will the researchers and personnel listed require additional training for this project/study?

Yes ☐No ☐

5. Research

☐Retrospective Chart reviews

☐Patient Surveys/Questionnaires

☐Patient Interviews

☐Staff Surveys/Questionnaires

☐Staff Interviews

☐Clinical Drug and Device Trials Phase Choose an item.

☐Clinical Research

· Number or Participants (patients/staff) to be recruited (applicable for all study types)?


6. Resources

a) Personnel – Expected number of hours required by each member of the team throughout the research project?

Name

Department

Hours per week






















b) Departments and services involved in research - List departments which will be involved in the research, this includes SLHD departments.

Department

Name of responsible person













c) Funding

Yes ☐ No ☐ Funding provided (Details must be provided in the CTRA)

If yes, indicate type:Choose an item.

Yes ☐ No ☐ Supply of medication

Yes ☐ No ☐Supply of equipment

7. Site-specific policies

Yes ☐ No ☐ Does the research comply with site-specific policies/requirements?

(e.g. NHMRC template used for participant information sheet and consent documents, must contain a witness section, and Form for Withdrawal of Participation.)

Yes ☐ No ☐ Has the project been reviewed by the Chris O’Brien Lifehouse Hospital Executive Committee (HEC)?

(Exceptions are commercially sponsored research and low risk as determined by a HREC)

8. Clinical Drug Trials Information

If the study is a clinical drug trial the following sections must be completed. N/A ☐

Yes ☐ No ☐Is the research project being conducted under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes?

Yes ☐ No ☐Are there Medicines Australia Standard Indemnity Form(s) for Chris O’Brien Lifehouse, signed by the sponsor attached?

Yes ☐ No ☐Are there Medicines Australia Standard Indemnity Form(s) for SLHD, signed by the sponsor attached?

(Required for all commercially sponsored research, and Phase I collaborative sponsored research)

Two options:

· Option 1 – Modified indemnity

· Option 2 – Standard Medicines Australia Form of Indemnity for Clinical Trials, and ‘SLHD Offer of Indemnity Letter’

Yes ☐ No ☐Is there evidence of adequate insurance cover attached?

(Level of insurance: minimum amount AUD 20 million per any one occurrence and in the annual aggregate)]

Yes ☐ No ☐Are there Medicines Australia Standard Clinical Trial Agreement(s)

Yes ☐ No ☐ Does the project involve participants receiving additional scans or radiotherapy treatment?

If yes, please attach the Chris O’Brien Radiation Safety Officers assessment.

Yes ☐ No ☐Does the project involve a Genetically Modified Organism (GMO)?

If yes, please submit all correspondence from SLHD Institutional Biosafety Committee review.

Yes ☐ No ☐Does the project require NHMRC Gene and Related Therapies Research Advisory Panel (GTRAP) assessment?

If yes, please provide the assessment report.

9. Device Trials Information

If the study is a device trial (or involves an unregistered device) the following sections must be completed. N/A ☐

Yes ☐ No ☐Is the research project being conducted under the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) schemes?

Yes ☐ No ☐Are there Medical technology Association of Australia (MTAA) Standard Indemnity for Clinical Investigation Form(s) for Chris O’Brien Lifehouse, signed by the sponsor attached?

Yes ☐ No ☐Are there Medical Technology Association of Australia (MTAA) Standard Indemnity for Clinical, for Sydney Local Health District signed by the sponsor attached?

(Required for all commercially sponsored research, and Phase I collaborative sponsored research)

Two options:

· Option 1 – Modified MTAA indemnity

· Option 2 – MTAA Standard Indemnity for Clinical and ‘SLHD Offer of Indemnity Letter’

Yes ☐ No ☐Is there evidence of adequate insurance cover attached?

(Level of insurance: minimum amount AUD 20 million per any one occurrence and in the annual aggregate)]

Yes ☐ No ☐Are there Medical Technology Association of Australia (MTAA) Standard Clinical Investigation Agreement(s), signed by the sponsor attached?

Yes ☐ No ☐ Does the project involve participants receiving additional scans or radiotherapy treatment?

If yes, please attach the Chris O’Brien Radiation Safety Officers assessment.

10. Declaration by the Principal Investigator and Associate Investigator(s)


1. 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.

2. I will only start this research project after obtaining authorisation from the site and approval from the responsible Human Research Ethics Committee (HREC);

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

4. 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.

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

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

7. I will adhere to the conditions of approval stipulated by the HREC and will cooperate with HREC monitoring requirements.

8. I will inform the HREC and the research governance officer if the research project ceases before the expected date. I will discontinue the research if the HREC withdraws ethical approval.

9. 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.

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

Name of Principal Investigator:

.

Signature: _____________________________________________________ Date: _______________________

Name of Associate Investigator 1:

Signature: _____________________________________________________ Date: _______________________

Name of Associate Investigator 2: Associate Investigator 2

Signature: _____________________________________________________ Date: _______________________


Signature: _____________________________________________________ Date: _______________________


Signature: _____________________________________________________ Date: _______________________


Signature: _____________________________________________________ Date: _______________________

11. Declaration by Head of Department where the Principal Investigator will do the research


I certify that I have read the research project application named above.

I certify that I have discussed this research project and the resource implications for this Department, with the Principal Investigator.

I certify that all researchers/students from my Department involved in the research project have the skills, training and experience necessary to undertake their role.

I certify that there are suitable and adequate facilities and resources for the research project to be conducted at this site.

My signature indicates that I support this research project being carried out using such resources.

Name of Department (or relevant section): Click or tap here to enter text.

Name: Click or tap here to enter text.

Signature: ______________________________________________ Date: __________________________

[Where an investigator is also Head of Department, certification must be sought from the person to whom the Head of Department is responsible. Investigators must not approve their own research on behalf of their Department.]

12. Declaration by Head of Supporting Department

This form is to be completed by the Head of any Department that is providing support/ services to the research project


Name of Department: Click or tap here to enter text.

I have discussed this project with the Principal Investigator and have read the research project. I am (tick whichever applies)

☐able to perform the investigations/services indicated, within the present resources of the Department;

☐able to perform the investigations/services indicated, if the following financial assistance is provided:

☐unable to undertake the investigations/services indicated, on the following grounds:

Name: Click or tap here to enter text. Date ________________________

Signature ___________________________________________________________________________






Name: Click or tap here to enter text. Date ________________________

Signature ______________________________________________________________________________






Name Click or tap here to enter text. Date ________________________

Signature ______________________________________________________________________________







Signature ______________________________________________________________________________







Signature ______________________________________________________________________________







Signature ______________________________________________________________________________

13. Declaration by the Authority for Data Provision

This form is to be completed by the person authorised to provide data services for research projects.


I have considered this proposal and consulted the appropriate personnel and I confirm that I have seen all relevant documents that are required. The Department(s) is (tick whichever applies):

able to confirm that the data services indicated will be provided, within the present resources;

able to confirm that the data services indicated will be provided, if the following financial assistance is provided:

unable to provide data services indicated, on the following grounds:

I certify that I will give due regard to any ethical conditions imposed by the approving HREC when deciding whether, and in what form, I will release data to the investigator.

Name of Custodian of Database: Click or tap here to enter text.

Position: Click or tap here to enter text.

Signature: ___________________________________________________ Date: ___________________________

_

14. Recommendation by the Research Governance Manager

Project Title:

The Site-Specific Assessment (SSA) form for the above research project has been completed (with all attachments).

SSA authorisation is:Recommended

Not recommended

Requires Chief Executive/delegate consideration

If not recommended or requires Chief Executive/delegate consideration, give reasons.

Research Governance Manager (or delegate)

Name: Click or tap here to enter text.

Signature: ______________________________________________ Date: _____________________________

15. Sydney Local Health District Authorisation

Authorisation by Chief Executive (or delegate)

To be completed by Research Governance Manager

Project Title:

HREC Reference:_________________________

For this study, the study site/s are proposed as follows:

⃝ Lifehouse as a site; or⃝ Both Lifehouse and SLHD as study sites

The following documents are attached:

1. a copy of the completed and signed NEAF and SSA form (completed either for LH as the Site, OR both LH and SLHD as sites for the study); and

2. evidence of insurance comprising either:

a. appropriate insurance procured by Lifehouse (including clinical trial insurance where required) as per the Service Delivery Agreement, with SLHD noted as an interested party; OR

b. for externally sponsored studies, certification of third party sponsor insurance (including clinical trials insurance where required) and other supporting documentation regarding liability and indemnity for sponsor related liabilities as required by SLHD; OR

c. other indemnity and/or insurance arrangements deemed acceptable by SLHD.

3. Other supporting and/or contractual documentation as required for this study.

My signature indicates that I authorise:

⃝SLHD as a Site for this Study

⃝Public Lifehouse Patients* participation in the above study at Chris O’Brien Lifehouse

⃝where required as part of the study, SLHD services accessed on an agreed fee for service basis and in accordance with the study protocol (actual fees to be as per separate agreement between LH and SLHD)

Name of Chief Executive (or delegate): ________________________________________________________

Signature: ______________________________________________ Date: _________________________

*Public Lifehouse Patients as defined by the Service Delivery Agreement between Lifehouse and SLHD 3/10/2013

16. Chris O’Brien Lifehouse Authorisation

Authorisation by Chief Executive (or delegate)


This research is: authorisednot authorised

Specify, conditions applying to authorisation or reasons for not authorising.

My signature indicates that I authorise / do not authorise this research project to commence at this site.

Name of Chief Executive (or delegate): Click or tap here to enter text.

Signature: ______________________________________________ Date: __________________________

Checklist


Completed by Researcher

Please complete the checklist and include with SSA Form

Has a copy of the HREC approval letter been provided?

Yes ☐ No ☐

Has a copy of the ethics application form been provided?

Yes ☐ No ☐

Has a copy of the protocol/Investigational plan been provided?

Yes ☐ No ☐

Are all Participant Information Sheet and Consent Form(s) attached in the NHMRC format, (including form for Withdrawal of Participation)?

Yes ☐ No ☐

Has a copy of the Investigator’s Brochure/drug information/device information been provided?

Yes ☐ No ☐ N/A ☐

Has a copy of advertising been provided?


Has a copy of any questionnaires been provided?


Has a copy of any other document, which will be given to research participants been provided? E.g.: identification card, patient diary


Are there Medicines Australia/MTAA Standard Indemnity Forms, for Chris O’Brien Lifehouse, signed by the sponsor, attached (if applicable)?


Are there Indemnity Forms, for Sydney Local Health District signed by the sponsor, attached (if applicable)?


Is evidence of adequate insurance cover attached?


Are there Clinical Trial Research Agreement(s), signed by the sponsor, attached?


Has evidence of Biosafety approval been provided?


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


Has evidence of an application for a licence to the NHMRC Licensing Committee, to conduct embryo research, been provided?


Has evidence of Radiation Safety approval been provided?


Have you included any other site-specific policy documents required by the Institution(s) at which you intend to conduct your research?


Is a “Declaration by Principal Investigator” signed and attached?

Yes ☐ No ☐

Is a “Declaration by Head of Department” signed and attached?

Yes ☐ No ☐

Is a “Declaration by Head of Supporting Department” signed and attached for each supporting Department (if applicable)?


Is a “Declaration by the Authority for Data Provision” signed and attached (if applicable)?


Chris O’Brien Lifehouse SSA FormVersion: 2.0 dated June 20195 | Page

chris o'brien lifehouse | treating people, not just cancer · web viewa copy of the completed and...

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