Post-authorisation

Dear SCHN Research Community,

NSW Health, via the Office of Health & Medical Research (OHMR), has issued a directive that all post approval and post authorisation applications and reports (e.g. amendments & annual / final reports) must be submitted via REGIS.

This directive has been implemented across the SCHN from 1st of April 2021.

Please see the following link that provides guidance on how to navigate REGIS for post approval and post authorisation: guide-_regis_post_approval_-_post_authorisation_slides_-_march_2021.pdf

Contact details for support:

 

Type of help / info

Who to contact

Contact details

REGIS technical issues

REGIS Helpdesk

Call 1300 073 447 or email support@f1solutions.com.au. The help desk is open Monday to Friday from 7 am to 7 pm (excluding public holidays).

SCHN specific processes  & requirements

SCHN Research Ethics & Governance teams

Ø  Research Ethics: SCHN-Ethics@health.nsw.gov.au

Ø  Research Governance: SCHN-Governance@health.nsw.gov.au

Feedback on using REGIS

The REGIS team at NSW Health

regis@health.nsw.go

  • Amendments 
  • Renewals and Extension requests
  • Annual reports
  • Clinical trials start up report
  • Insurance certificates
  • Protocol violations
  • Other (memos, notifications) 
  • Declaration Forms and Amendment Form.

 

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.

General Amendment 

  • Changes to the study protocol, including the conduct and / or design of the study
  • Changes to any other study documentation (e.g. consent and recruitment material, study tools)
Ethics Approval is required

Amendment to Research Governance Via REGIS

Change to PI

  • Change to the Principal Investigator/s
Ethics Approval is required

Amendment to Research Governance Via REGIS 

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

  • Note: NON-SCHN employees need to contact the workforce department for workforce clearance prior to the amendment submission.

Ethics Approval is NOT  required

Amendment to Research Governance Via REGIS
 Amendments to CTRAs

Ethics Approval is NOT  required

 

Amendment to Research Governance Via REGIS 

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

Ethics Approval is NOT  required

Amendment to Research Governance Via REGIS 

  • Link to REGIS QRGs: https://regis.health.nsw.gov.au/how-to/
  • For amendments to existing agreements: Completing amendment in the REGIS + 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.
  • For new agreements:  contract instruction sheet

 All Amendments to the Access request studies need to be submitted to us via email into: SCHN-Governance@health.nsw.gov.au

 

NOTE : Research Governance no longer accepts IBs, IB amendments, SUSAR line listings , IDMC report, CSR, DSUR and memos that have no impact on the conduct of the study at our site .

  

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

Please be reminded you cannot commence an amendment at a SCHN site until you have received authorisation of your application as stated in the Governance Amendment Form.

Renewals and Extension requests

Extension or Renewal of the SSAs/ STEs which are  approved by a  NSW / ACT HRECs

CPI submits HREC extension amendment to HREC in REGIS and the expiry date automatically will be updated for Governance once the ethics approve it.

Amendment to Research Governance is NOT required.

Extension or Renewal of the SSAs/ STEs which are  approved by all Other Ethics (including interstate Ethics Approval)

CPI submits amendment to the HREC as per their instructions. And PI submits the HREC extension form and approval for each related STE RGO on REGIS.

Amendment to Research Governance Via REGIS is required.

For amendment to extend or renew the studies which are approved by ETHICS outside of NSW / ACT kindly submit to Research Governance the following documents together along the Amendment in REGIS:

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:

Declaration A

Declaration B

Declaration C

Declaration D

Annual / Final Report 

A site progress report must be provided 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 via REGIS. 

Annual / Final Reports for the SSAs/ STEs which are  approved by a  NSW / ACT HRECs

CPI submits annual / final form to HREC in REGIS and the reports automatically will be shared with Research Governance once the ethics approve it .

Submission of Annual/ Final report to Research Governance is NOT required.

Annual / Final Reports for the SSAs/ STEs which are  approved by all Other Ethics (including interstate Ethics Approval)

CPI submits annual / final to HREC as per their instructions. And PI submits the annual / final report to Governance on REGIS..

Submission of Annual/ Final report to Research Governance is required. Please submit it to us via REGIS.

Documents required: Please complete the Regis annual report form  and upload the approving/lead HREC annual report form and HREC acknowledgment correspondence (email/formal letter).

Annual / Final Reports for the Access request studies need to be submitted to us via email into: SCHN-Governance@health.nsw.gov.au

Documents required: The approving/lead HREC annual report form and HREC acknowledgment correspondence (email/formal letter).


  • For projects migrated from the previous system (Online Forms), the appropriate milestones for annual reports may have not been created for your project on REGIS. If you cannot find the relevant milestone on REGIS to submit your annual report, please contact the Research Ethics / Governance Office so that they can manually create the milestones for you. 
A separate Annual Safety report submission is no longer required. For clinical trials, the Annual Safety report is built into the annual progress report. You will be asked if you want to submit the annual safety report. Selecting ‘Yes’ will generate additional questions. And if the study is not a clinical trial there is a single safety question.    

Clinical trials start up report

The Clinical Trial’s Start Up report is a research governance only milestone.It is a report of the date the first participant was enrolled into a clinical trial, consented and screened with eligibility verified.This report / milestone must be submitted to research governance as per the instructions in the REGIS QRG

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 REGIS. 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. 

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.

Declaration Forms and Amendment Form.

Research Governance amendment form

Declaration A

Declaration B

Declaration C

Declaration D