Post-authorisation

  • Amendments
  • Annual reports
  • Clinical trials start up report
  • Insurance certificates
  • Protocol violations
  • Renewals
  • Other (memos, notifications)

It is a requirement of ongoing site authorisation that amendments and annual reports be submitted to Research Governance after they have been approved by the Human Research Ethics Committee that approved the study.

The following guidance is provided as an interim measure while the Research Governance post-authorisation guidelines are under development. The post-authorisation guidelines will be communicated as soon as they receive policy and procedure committee approval.

Please note: The post-authorisation submission process of SSAs/LNRSSAs for projects authorised at SCHN through both Online Forms and REGIS will continue as per current process until further notice. Please see further details below.

Amendments to existing applications

Amendments to your project (e.g. a change in protocol, investigators, procedures) including short term study extensions, amendments to CTRAs, other agreements or organising a new agreement for an existing study must be submitted to Research Governance for authorisation and execution, respectively. 

Amendments requiring a corresponding HREC approval must receive that approval BEFORE submitting to Governance.

Documents required: RGO amendment form in Word format (minimum requirement for registration)

Where to submit: SCHN-Governance@health.nsw.gov.au

Please follow the guidelines in the amendment form as to the other documents required to complete the review. Research Governance will review the amendments using similar criteria to the SSA review process.

We will endeavour to review amendments within 8 working days.  You cannot commence an amendment at a SCHN site until you have received authorisation of your application as stated in the Governance Amendment Form.

Amendments requiring Research Governance authorisation only (not requiring HREC approval)

The following instances are where only Research Governance authorisation is required:

1. Addition of site personnel (Associate Investigators and site support personnel such as Research Assistants)

Documents required: amendment form in Word format + relevant documents for the addition/change in site personnel

2. Amendments to agreements or organising a new agreement that does not involve an amendment to a protocol and/or patient information sheets

a) For amendments to existing agreements: amendment form in Word format + tracked changed agreement in Word format + clean version. Ensure that a clear description of the amendment to the agreement is clearly stated in the amendment form.

b) For new agreements: amendment form in Word format + contract instruction sheet

Please note: Change to a SCHN Principal Investigator requires both HREC approval and Research Governance authorisation.

Forms:

Research Governance amendment form

Declaration A

Declaration B

Declaration C

Declaration D

Annual reports

A site progress report must be submitted annually to the research governance office using the approving/lead HREC annual report form and HREC acknowledgment correspondence (email/formal letter) to the SCHN-Governance Inbox.

Annual Safety Reports

An Annual Safety report must be submitted annually to the research governance office using the approving/lead HREC annual safety report form + HREC acknowledgment correspondence (email/formal letter) to the SCHN-Governance Inbox.

Developmental safety update reports are considered part of the Annual Safety report and should be submitted as per above guidelines.

Note: Research Governance no longer accepts IBs and Line Listings.

Clinical trials start up report

If your project is a clinical trial you are required to submit the Clinical trial start-up report to Research Governance within 60 days of receiving Governance authorisation.

RGO clinical trial start-up report first patient recruitment

Insurance

Where ongoing evidence of current insurance is required, please submit the insurance certificate/s (Clinical Trial, Professional Indemnity and Public Liability Insurance) to Research Governance via email to SCHN-Governance@health.nsw.gov.au.  A Research Governance amendment form is not required.

Certificates for industry sponsored clinical trials must contain the following information:

a)      Policy issued by an insurer approved by Australian Prudential Regulation Authority

b)      Policy should mention the name of the insured and this must be an Australian legal entity

c)       Policy should state the period of cover- 

d)      Evidence a policy contains insurance cover for a minimum of AUD20,000,000 for any one occurrence and in the annual aggregate.

e)      Evidence that the policy’s deductible/excess or self-insured retention does not exceed AUD25,000

A commercial sponsor may meet these insurance requirements by effecting a single policy or multiple policies.

Authorisation may be withdrawn if a clinical trial’s insurance expires and a new valid insurance certificate is not provided.

Insurance cover for investigator-initiated clinical trials or other clinical research which does not meet the above criteria will be reviewed by the Research Governance Officer on a case-by-case basis. 

Protocol violations

Protocol violations are NOT required to be submitted to Research Governance for review. If a violation results in an adverse event reportable under the NSW Health Policy and OHMR’s safety reporting pathways, or requires an amendment please follow instructions below regarding amendments and OHMR’s Safety Reporting Guidelines.

Minor protocol deviations such as out of window visits, missed tests, etc can be included as a table of deviations attached to the annual report.

Renewals 

If a 5 year renewal of authorisation is required, kindly submit to Research Governance the following documents together with a completed RGO amendment form in Word format:

1) HREC Renewal form and Approval of Renewal letter

2) All HREC renewed documents listed in the approval of renewal letter (protocol, Master PICFs, etc)

3) Current site-specific documents already authorised at site that will continue to be used at site (for renewal of authorisation) - ensure most current logo affixed

4) Complete list of current authorised site study team (SCH and CHW- whichever is applicable for the renewal application) 

5) Most current Annual report and HREC acknowledgment of annual report

6) Declaration B from the PI’s HOD acknowledging the renewal

7) Declaration C from Supporting Departments who are required to continue providing support**

8) Declaration D from HIU Manager if Electronic or Paper Medical Records are going to be accessed**

**As this is a renewal, an email acknowledging ongoing support will be accepted.

Changes to ongoing support or a new department providing support requires a signed Declaration C or D.

If any agreements were executed with other organisations, let us know so that we can check our records (if any) whether they are still valid or they need to be extended or a new agreement needs to be executed. Provide a TRIM number if applicable.

Forms:

Research Governance amendment form

Declaration A

Declaration B

Declaration C

Declaration D

Other (memos, notifications)

Memos and notifications that are administrative in nature should be included in the subsequent Protocol Amendment submission where this memo also applies.

Memos or notifications that fulfil the criteria of a Significant Safety Issue (SSI) should be submitted using the SSI Submission Pathway.