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Governance only – SSA

  • Refer to advice on the New applications page that applies to all studies regardless of submission type. This will include:

    • REG Application Coversheet
    • Pre-submission survey
    • Ethics Review Manager (ERM) Project Id number
    • Fee payment

    If your study has received ethical approval from a certified HREC other than the RCH, as part of the National Mutual Acceptance (NMA) scheme, you need to submit a Governance Only ‘Site Specific Assessment (SSA)’ Application.

    There are no closing dates for SSA applications – they can be submitted for review at any time.

    Submission process

    A governance only SSA submission in ERM can be done in either of two ways. The SSA form may be created by:

    OPTION 1: Using the existing ERM Human Research Ethics Application (HREA) that has already been created by a lead site who uses ERM. Victoria and Queensland sites use ERM.

    OPTION 2: Creating a Minimal Dataset Form (MDF) to be used as a proxy form when the lead site does not use ERM. In this option the HREA needs to be attached as an uploaded document when prompted. Following the completion of the MDF the SSA can be created as a sub-form for the governance application. NOTE: If an MDF has already been created by another participating site this can be used. Only one MDF is required so that the study maintains the one ERM Project Id number.

    IMPORTANT NOTE

    If OPTION 1: using the ERM HREA is applicable, the RCH REG office can access all the original ethics documents that were submitted to the HREC. Therefore these do not need to be re-uploaded to the SSA form. HOWEVER, if there have been subsequent amendments the REG office cannot access these and therefore you are prompted to upload these amended documents to the SSA.

    In the above situation it can be difficult for the REG reviewer to determine what is the full set of current documents. Multiple ethics amendments further exacerbate this situation. To assist the REG reviewer to understand the full set of current documents and for us to subsequently provide a more efficient review we suggest providing a zip file of the current ethically approved set. This can be labelled 'Current Ethics Set [date]' and uploaded to the SSA at Supporting Documents.

    If OPTION 2: using an MDF is applicable, the researcher needs to manually upload all the documents reviewed in the ethics application to the MDF. If amendments have occurred the same request to provide a zip file applies as above. 

    Documents required

    The following documents are required when submitting an SSA application for governance authorisation (as applicable):

    Document 
    • HREC Ethics Approval Letter
      • This must list RCH or MCRI as an approved participating site. 
    • HREC Ethics Amendment Approval Letter(s), if applicable.
      • See IMPORTANT NOTE above for submission of additional documents.
    • HREA
    • Victorian Specific Module (VSM)
    • RCH Participant Information Statement and Consent Form. (Tracked)
      • This must be a copy of the master PICF showing the RCH changes in tracked format.
    • RCH Parent/Guardian Information Statement and Consent Form. (Tracked)
    • RCH Child Information Sheet. (Tracked)
    • Other RCH site specific documents for participants such as flyers, letters, contact forms, advertisements, questionnaires, diaries etc. (Tracked) 
      • Some of these master documents may or may not need to be made site specific.
    • Indemnity (if commercially sponsored)
    • Insurance Certificate (if commercially sponsored)
    • Medical Physicists Report (both RCH and lead site). This is to be listed on the HREC approval letter
    • Site Budget
    • Supporting Department Declarations completed via the MCC Department and Ethics Research Platform are applicable for the following departments:
      • Audiology
      • Clinical Trials Pharmacy
      • Day Medical Unit
      • Endocrinology
      • MCRU
      • Medical Physicist Report
      • Medical Imaging
      • Pathology/Lab Services
      • If there has been an ethics amendment(s) provide a zip file of ALL CURRENT versions of ethics approved documents. DO NOT INCLUDE SUPERSEDED DOCUMENTS. Label the file 'Current Ethics Set [date]'. See IMPORTANT NOTE above.
        • Protocol
        • Investigator's Brochure, and other product information
        • Master PICFs and other participant facing documents, such as flyers, letters, contact forms, advertisements, questionnaires, diaries etc.
        • Other documents as listed on ethics approval letters and any ethics amendment approval letters.

      Handy hints

      • File names. Following the below will assist in quicker review times.
        • Ensure documents provided to REG have the same file name as the Ethics Approval Certificate. Inconsistent naming can create confusion.
        • Where the file name does not identify the document type please add a prefix or suffix to assist in identification. For example, adding 'Ethics Approval 16Dec22'. 
        • Consistent naming styles at the start of a file name for the same document types results in downloaded files being grouped together in the same section of the downloaded list.
        • Keep file names as short as possible so that the name is not cut off when downloaded from ERM. For example, 'Royal Children's Hospital' can be reduced to 'RCH', or 'RCH site specific' can just be 'RCH'. 
      • Tracked site specific documents. Please take the master approved document and track changes to make it specific for this site. Site specific documents must have RCH or MCRI at the start of the file name to identify them as such. Provision of clean site specific documents is not essential as the REG reviewer can hide tracked changes to view the clean copy.
      • Footers. Ensure site specific governance documents include footers showing appropriate version control. For example, 'RCH Parent/Guardian ICF, Version 1, dated 01 March 2023, based on Master Parent/Guardian ICF, Version 1, dated 20 January 2023'. 
      • REG office contact. Our contact person details for PICFs are 'Director, Research Operations, Phone (03) 9345 5044 and Email rch.ethics@rch.org.au'.
      • Summary of inclusions. If not all study activities listed in the Protocol and Participant Information Statements are to occur at RCH or MCRI please provide a brief summary outlining the site scope and a list of which ethically approved documents are not relevant to RCH. This will enable quicker review times by the REG office.