Research amendments

To add a CALHN investigator submit:

• amendment request form
• CV
• good clinical practise (GCP) certificate
• study team declaration.

To add a Non-SA Health investigator submit: 

• amendment request form
• CV
• GCP certificate
• study team declaration
• police check - if the investigator is going to be on site
• confidentiality deed - if the investigator will be contact with patients or have access to patient data.

For changing or updating the principal investigator (PI) or the coordinating principal investigator (CPI) submit:

• amendment request form
• CV
• GCP certificate
• study team declaration.

For adding a new National Mutual Acceptance (NMA) Scheme listed site submit:

• amendment request form
• any updated study documents (tracked and clean copies).
• To add a private site an External Entities Agreement (EEA) is required to be fully executed before site commencement.

Updates to study documents such as the protocol, investigator brochure (IB) or patient information consent form (PICF):

• amendment request form
• any updated study documents (tracked and clean copies).

Adding a waiver of consent (WOC):

• amendment request form
• tracked and clean protocol answering in detail section 2.3.10 of the National Statement. 

For multi-site studies where there is an external reviewing HREC and an amendment requires Research Governance Office (RGO) acknowledgement submit:

• All documents for acknowledgement (submitted to the reviewing ethics).
• External acknowledgement approval of documents (sent by the reviewing ethics).

Researchers have the option to submit amendments through the SA Health Research Governance and Ethics Management System (GEMS) or through email to Health.CALHNResearchMonitoring@sa.gov.au.

To submit the amendment using GEMS user guides are available on the SA Health website.

To submit reports to Health.CALHNResearchMonitoring@sa.gov.au:

1. Download the amendment request form.
2. Ensure the principal investigator (PI) for the study has signed the bottom of the form and is Cc'd in the email.
3. Ensure all relevant documents are attached to the email depending on the amendment submission type.
4. Submit the amendment to Health.CALHNResearchMonitoring@sa.gov.au.

Where the Northern Adelaide Local Health Network (NALHN) or Southern Adelaide Local Health Network (SALHN) have sites listed on the report please confirm with RGO what their preferred method of submission is before continuing. 

• Submit an amendment form with a clear explanation for changes.
• Submit both tracked and clean versions for updated study documents.
• Ensure document footers including dates and versions are current.
• Ensure you have attached the correct documentation for your submission and have organised the required signatures and approvals.