What type of research new

Data Access Request Form: You may be eligible to use a Data Access Request Form in lieu of an SSA, but authorisation to do so must be gained from the RGO before submission.  Please email the RGO for the current version of the form.

SSA – Site Specific Application

Full Site Specific Applications (SSA) must be completed online https://au.ethicsform.org/SignIn.aspx and submitted in PDF to the Research Governance Office (RGO).

If you used Online Forms to complete the Ethics Application key project information will be populated into the relevant fields of the SSA to reduce the need for duplication.  You may need to change the information to ensure it is site specific.

Completing the Application

If you have any questions regarding the content of the SSA including how to answer specific questions in the application please review the NALHN Specific – SSA Completion Guide.

NALHN-SSA-Completion-Guide-Jan-2018

If you cannot find your answer in the guide please contact the RGO: mailto:healthnalhnrgo@sa.gov.au

Research Coordinator Form (Clinical Trials Only)

This form must be completed and submitted alongside the SSA.

Research Coordinator Form

Technical Support

Technical support for the application form is available:

Tel: +61 2 903 78 404 (available from 10am to 4pm AEST Mon to Fri)
E-mail: helpdesk@infonetica.net

Creating a Submission Code

Once all sections of your SSA are complete, it is necessary to create a submission code before providing the application to the RGO.  This is done in Online Forms by:

  1. Selecting the SSA under “My Project” in the menu bar
  2. Select the “Submission” tab
  3. Click the “Generate Submission Code” button

Generating Submission Code 2

Once you have generated the submission code you must print a copy of the form (the submission code generated will appear in the footer of the form).  A copy of the SSA and all supporting documentation must then be submitted to the Research Governance Office along with the SSA Research Governance Application Cover Letter Jan 2018

Note: Generating a submission code does not send your application to the RGO, it assigns a version code to the bottom of the document and removes the draft watermark.  All page numbers must have matching codes before submission to the RGO.  These codes must not be altered by hand.

Evidence of Human Research Ethics Committee (HREC) approval must be provided to the RGO before the CEO/Delegate can authorise the SSA. Please note that project authorisation is not instantaneous nor is it guaranteed.  In the event that the project is not authorised, feedback will be provided.

Dual submission: site assessment and ethical review may occur in parallel.  However the decision to authorise or not authorise the commencement of a research project at the site can only be made once the HREC has approved the project.

 

 

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Low/Negligible Risk (LNR) Applications

The NHMRC National Statement on Ethical Conduct in Human Research (2007) defines low risk research as “research where the only foreseeable risk is one of discomfort”.  Discomfort may include minor side-effects of medication, discomfort related to measuring blood pressure or anxiety induced by an interview.  Where the risk, even if unlikely, is more serious than discomfort, the research is not low risk.

For applications where either:

  • NALHN is the only SA Health site involved, or
  • NALHN and CALHN are the only SA Health sites involved

Submission is via the Low/Negligible Risk Ethics and Governance Application (LNREGA) Form

Low/Negligible Risk Ethics and Governance Application Form

Low/Negligible Risk Application Guidelines

Submission for ethical review is via email to Health.CALHNResearchLNR@sa.gov.au

Submission for governance (site) review is via email to HealthNALHNRGO@sa.gov.au

For studies involving other SA Health or public health sites submission is via the Online Forms system – see the Site Specific Application tab above.

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eCTN

For sponsors submitting eCTNs for clinical trials being conducted at Lyell McEwin or Modbury Hospital the approving authority information is provided below:

Name of Approving Authority:  Northern Adelaide Local Health Network Incorporated operating  as Lyell McEwin Hospital (select appropriate site), or
Northern Adelaide Local Health Network Incorporated operating as Modbury Hospital
Approving Authority Contact Officer:  Alison Barr
Position:  Research Governance Officer
Contact Phone:  +61 8 8182 9346
Contact Email:  Alison.Barr@sa.gov.au

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CTRAs – Clinical Research Agreements

If your project involves a medicine or device you need to submit an agreement between the parties involved.  This is required whether you are involved in a :

  • Collaborative Group project
  • Commercially Sponsored project
  • Contract Research Organisation or,
  • Project funded from a grant

Medicines Australia Standard CTRA templates are endorsed by SA Health and should be used wherever possible to avoid the need for legal review:  https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/

Amendments to Schedule 7 or Schedule 4 require SEBS approval.  Please see the above link for further information.

Site Details for inclusion in the template (select appropriate site):

Edit
Name of Institution: Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital
Address: Haydown Road, Elizabeth Vale, South Australia 5112
ABN: 46 371 200 573
Edit
Name of Institution: Northern Adelaide Local Health Network Incorporated, operating as Modbury Hospital
Address: 41-69 Smart Road, Modbury, South Australia 5092
ABN: 46 371 200 573

Schedule 2: (Please include the following information)

Governance Fee:
Research governance submission fees are payable to the Institution according to the current fee schedule. The research governance office will invoice the sponsor directly. http://www.sahealth.sa.gov.au/wps/wcm/connect/public+content/sa+health+internet/about+us/health+and+medical+research/research+ethics/research+ethics+and+governance+fees

Pharmacy Fees:
Pharmacy fees inclusive of dispensing will be invoiced directly by Pharmacy.

Payee:
All payments listed in this schedule will be made by the Sponsor to Institution upon receipt of a tax invoice by direct credit.
Bank: Commonwealth Bank of Australia
Branch: 96 King William St, Adelaide
BSB: 065 266      Account Number: 10020646
Account Name: NALHN Oracle Operating
ABN: 46 371 200 573
Swift Code: CTBAAU2S

Note: The sponsor is responsible for study payments and must be the party in Schedule 2 that NALHN will invoice

For information on how to negotiate the study budget for inclusion in the CTRA please review the following Study Budget and Financial Authorisation page:
http://www.basilhetzelinstitute.com.au/research/information-for-researchers/nalhn/study-budget-financial-authorisation/

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Indemnity

Medicines Australia Standard Indemnity templates are endorsed by SA Health: https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/

Site details for inclusion in the template (select appropriate site):

Northern Adelaide Local Health Network Incorporated, operating as Lyell McEwin Hospital (“the Indemnified Party”)
or
Northern Adelaide Local Health Network Incorporated, operating as Modbury Hospital (“the Indemnified Party”)

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Confidentiality Deed

Researchers may come into contact with information that must be kept confidential.
Any person engaged in activities on NALHN sites should be aware of the fact that a breach of confidentiality is an offence under Section 93 of the Health Care Act 2008 (SA) (‘the Act’). Any such offence can result in the termination of the access, action for damages and/or prosecution.
All non SA Health staff must sign a Confidentiality Deed and attach it with their SSA.  NALHN Confidentiality Deed non-NALHN Employee

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DCSI Check

SA Health complies with the legal requirement that every person seeking to work under the Children’s Protection Act and Regulations 2010 or the Aged Care Act 1997 undergo a criminal and relevant history screening assessment.
This applies whether or not the person is currently working in SA Health. The assessments are carried out by the Department for Communities and Social Inclusion and are current for three years. The cost of the assessment is borne by prospective researcher.  http://screening.dcsi.sa.gov.au/

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Other Essential Documents

Other documents required with your SSA include:

  • Participant Information Sheet and Consent Form (PICF)
  • CV & GCP Certificate for the Principal Investigator (PI)
  • Ethics Approval Letter
  • Protocol
  • Investigator Brochure
  • Copy of advertisements (flyers, posters)

Site Specific – Participant Information and Consent Forms (PICFs)

NALHN endorses use of the NHMRC standardised PICFs which are designed for three categories of participants identified by the National Statement:

  • Individual participant
  • Child participant
  • Participants unable to provide consent

Templates are available on the NHMRC website:  https://hrep.nhmrc.gov.au/toolbox/standardised-forms

It is an SA Health requirement that the institution logo is used – please insert the SA Health Logo in the Header of your Participant Information Sheet and Consent Form (right click on image, copy and paste into your document).

SA Health Logo

Site Contact details for Complaints 

The contact details of the approving HREC  should be included in the Participant Information Sheet  should the participant want to speak with someone independent of the project or make a complaint about the study/investigators.  However, if the approving HREC is not an SA Health HREC, the RGO contact details must be included.

Example 1: Where the reviewing HREC is an SA Health HREC e.g. Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact”:

Reviewing HREC approving this research and HREC Executive Officer details:

Reviewing HREC name Central Adelaide Local Health Network Human Research Ethics Committee (CALHN HREC)
HREC Executive Officer Heather O’Dea
Telephone 8222 6841
Email Health.CALHNResearchEthics@sa.gov.au

Example 2: Wording for use in the PICF when the approving HREC is not an SA Health Committee
For matters relating to research at the site at which you are participating, the details of the local site complaints person are

Name Alison Barr
Position NALHN Research Governance Officer
Telephone 8182 9346
Email healthnalhnrgo@sa.gov.au

GCP

A Principal Investigator is the individual responsible for the conduct of a clinical trial. They must ensure that it complies with GCP guidelines. If a trial is conducted by a team of individuals at a site, the principal investigator is the responsible leader of the team and may delegate tasks to other team members.

NALHN requires that all principal investigators on clinical trials hold current good clinical practice (GCP) certification.  As the PI is responsible for the conduct of the study at the site, it is their responsibility to ensure that their research staffs have GCP training.

NALHN has adopted the minimum standards defined by TransCelerate Biopharma Inc. http://www.transceleratebiopharmainc.com/gcp-training-attestation/  to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations.  Acceptable GCP training courses are those listed on TransCelerate Biopharma Inc.

INC Research IATA & GCP Refresher Training

https://www.incrclinicaleducation.com/Account/Registration

ARCS GCP Training

https://www.arcs.com.au/

The ARCS Applied GCP Training course meets the minimum standards defined by TransCelerate Biopharma Inc.

The course, Applied GCP Training for Investigational Sites and Sponsors Representatives (Certificates 1, 2 and 3), can be undertaken at the researchers own pace and takes approximately 8-10 hours to compete. The training is principally focused on best practice in clinical trials research but is sufficiently broad in scope so as to benefit all clinical researchers.

Upon completion of the program researchers should have a good understanding of the Australian regulations and ICH-GCP and ideas to consider when adhering to these during the conduct of research and also a clear understanding of the roles and responsibilities of all stakeholders in clinical research. Researchers who complete the training revive a certificate of completion which is valid for three years from the completion date.

Advertisements

All advertisements must be first approved by the Media and Communications Department: HEALTH.NorthernCommunication@sa.gov.au

Evidence of approval from Media and Communications must be included with your SSA.

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