Post Approval Guidelines- Governance
After approval has been granted there may be changes made to the study which must be reviewed and approved by the Lead HREC. There are some amendments which do not require Lead HREC approval, you must seek the advice of the Research Support Office in these situations.
All amendments that have been approved by a Lead HREC must be submitted to the Research Support Office for approval or acknowledgement by a member of the research governance team by completing the SESLHD Amendment Form.
During the study, safety reports (Significant Safety Issues and SUSAR/USADE/URSAE) must be submitted in accordance with safety report guidelines and on the appropriate form.
- Protocol Amendments – these are any changes made to the approved protocol which may range from administrative, scientific or logistical changes.
- IB Amendments – these are changes or updates made to the Investigator Brochure for a drug or device. These changes will be acknowledged and noted.
- Amendments to the Participant Information Sheet and Consent Forms (PISCFs) – are any changes made to these forms and approved by HREC. If they are only site specific changes and do not affect any other non-SESLHD site listed on the ethics approval letter then the research governance review is only required. HREC approval in this instance is not required. Usually changes to the PISCFs are triggered or related to changes to the Protocol or IB.
- Changes to study personnel – are amendments where study personnel are added or removed. HRECs will only approve changes to the Principal or Coordinating Investigator. Research Governance requires submission of any study personnel change particularly when new researchers or personnel are being added on. Addition of non-NSW Health/SESLHD researchers will be captured and screened appropriately through an Honorary Research Associate Application.
- Changes to supporting documents e.g surveys, questionnaires, posters, data collection forms – These changes will be acknowledged and noted, as research governance rarely make changes to these documents.
- Addition of a supporting department – studies may require the support of another department to continue the operation of the study project. The research governance process will require written support from the head of that department. This may be triggered by an added test to the protocol. Please note that this does not require HREC approval however it is one main research governance amendment.
- Changes to a research agreement – These can be considered as amendments at the discretion of the Research Governance Officer.
- Any changes to sponsorship – This will affect all study documents including research agreements and indemnities.
- Any changes to study title – Although this is a minor change it requires changes to all study documents, research agreements, indemnities and notification to the TGA if necessary.
- Changes to drug/device whether adding or removing from the study – These changes requires amendments to the protocol, participant information sheets and consent forms, CTN where necessary and updates to the IB.
- Engagement with third party service providers – protocol amendments may trigger the requirement to engage with a third party to conduct tests that cannot be done internally.
- Addition or removal of an investigator or any other research personnel other than the Principal or Coordinating Investigator
- Addition or removal of a supporting department
- Changes to a research agreement for study budget updates, formality changes and any change that does not require ethics approval
- For multisite studies where changes are only specific to a particular site, HREC will only approve the master version. Any site specific changes can be approved without ethics endorsement
- When the site engages a third party service provider to fulfil study obligations under the protocol.
All amendments must be submitted to the RSO Inbox attaching the following documents:
- SESLHD Amendment Form
- HREC approval letter where applicable
- Agreements where applicable
- All supporting study documents listed on the HREC approval letter
- Where ethics approval is not required, all supporting documents relevant to the amendment
- Signed Declaration A Forms for new investigators where applicable.
All Progress or Final Reports must be submitted to the RSO Inbox with the HREC acknowledgement or approval letter.
As required by the Medicine’s Australia Clinical Trial Research Agreement for a commercially sponsored clinical trial, an insurance certificate is provided as a schedule to that agreement. The Sponsor is required to provide the institution an updated insurance certificate of currency each year to the RSO Inbox. Updated insurance certificates does not require HREC approval.
In regards to any change to research personnel, SESLHD HREC will only approve a change to the Coordinating Investigator or Principal Investigator. The research governance process requires notification to any addition or change of investigators including research personnel.
For changes to the Principal Investigator the SESLHD Amendment Form and following documents are required to be submitted to the RSO Inbox:
- A copy of CV
- Signed declaration section of the approved SSA. The investigator can hand write their details, sign then date this signature page and then scan and send the page to the RSO.
- If this investigator is not a SESLHD employee please refer to the Honorary Research Associate Application (HRAA) information on the website for further information.
If there are changes to the CTRA, an amendment agreement is required. These agreements are often referred to as Variation Agreements or Amendment to the CTRA. Three copies of the amendment agreement must be signed by the Sponsor and PI where necessary and then sent to the RSO Office for countersignature. A copy must also be sent to the RSO Inbox.
The NSW Office for Health and Medical Research requires NSW Health sites to collect metrics relating to participant recruitment to commercially sponsored clinical trials.
The target is to recruit the first participant within 40 calendar days following SSA approval. OHMR acknowledges that there are valid reasons why this would not be possible, for example, in rare diseases or studies involving small participant populations.
Please provide the following information relating to the above study to the RSO Inbox:
- Date of first participant recruited, if not within 40 calendar days please provide a brief reason
- If study has not yet recruited, please provide a brief reason for not reaching this enrolment target.
Significant Safety Issues and SUSAR/USADE/URSAE: safety reports must be submitted in accordance with safety report guidelines and on the appropriate form.
The NSW OHMR has formally accepted and endorsed the updated NHMRC Safety Reporting Guidance and in response, has published a new Policy Directive (PD2017_039) titled 'Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations'. This is effective now, applies to new and existing research projects and aligns with national and international standards.
What are the changes to the reporting requirements?
Fewer reports are required, and all safety reporting to the HREC and/or Research Governance Officer (RSO) is the responsibility of the Sponsor of the trial.
The OHMR has mandated the use of 2 forms. Please use them from now on:
- Significant Safety Issue (SSI) Notification Form (reporting from the Sponsor to the HREC)
- SUSAR/USADE/URSAE Notification Form (reporting from Local Investigator to the local RGO).
RGOs will no longer receive: Single case AEs, SAE/SARs and external SUSARs* or device/non-therapeutic good equivalents or six monthly line listings.
RGOs will receive:
- local SSIs;
- local SUSARs/USADEs/URSAEs; and
- any research-related events that meet the definition of an incident
Report all local SUSARs/USADEs/URSAEs in the Local SUSAR/USADE/URSAE Notification Form.
*Note: If a SAE/SAR/SUSAR meets the definition of an SSI, it will be reported to the HREC/RGO through that reporting mechanism.
In trials where SESLHD is the sponsor, the sponsor’s reporting responsibility is delegated by the SESLHD CE to the Coordinating Principal Investigator or Principal Investigator. It is the responsibility of the CPI/PI to ensure compliance with NHMRC and OHMR policy and guidance.
Where the sponsor is another entity - for example, a University, you should seek guidance from that institution. It is likely that the delegation will be to the Principal Investigator.
Please also see the following policies/guidelines for further information:
- Safety Monitoring and Reporting for Clinical Trials Conducted in NSW Public Health Organisations
- Guidance: Safety monitoring and reporting for clinical trials
- Risk-based Management and Monitoring of Clinical Trials Involving Therapeutic Goods
- Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.