Reporting and Monitoring

Staff undertaking approved research must follow a strict set of guidelines while conducting their project. All staff involved with the research project must ensure that: 

• No research is conducted which has not received ethics approval by an HREC and authorisation via the relevant site specific Research Governance Officer (RGO)
• All relevant information has been provided to the HREC and the relevant RGO
• Compliance with all relevant guidelines and legal requirements
• Monitoring requirements are complied with, for example annual reports, safety reporting 
• Proposed protocol modifications and amendments are submitted to the HREC Sub Committee for approval and ongoing site authorisation to the RGO 
• Adverse events are promptly notified

All projects require ongoing research governance site authorisation. The Principle Investigator is responsible for advising the RGO of any amendments to their project/s, as well as submitting annual and final reports, and adverse event reports.

WSLHD HREC advises the WSLHD RGO of all amendments, reports and so on for studies taking place on WSLHD facilities. They do not advise non-WSLHD RGOs: the Principle Investigator will need to advise the appropriate RGO.

Non-WSLHD HREC approved studies only

For ongoing authorisation to run your project within WSLHD, the Research Governance Ongoing Site Authorisation Form (docx) should be completed by the researcher and signed by the Principal Investigator and forwarded, along with any relevant documents, to the RGO at Westmead Hospital. The ongoing site authorisation form will be acknowledged and returned to the Principal Investigator. If another person requires a copy their details can be added at the end of the form.

Examples

• Annual report Annual insurance certificate (if applicable)
• CTN acknowledgment form (if applicable)
• Any correspondence with HREC that impacts on the conduct of the study at the site
• Updated legal documentation (if applicable)
• Adverse event reports (if applicable)
• Change of research personnel at site (if applicable)

Annual reporting is a condition of your ethics approval. One of these forms (on the right) must be submitted annually, in November, to the WSLHD HREC to maintain ongoing HREC approval. If November is not suitable submission date, please liaise with the WSLHD HRE office.

For non-WSLHD HREC approved projects, please contact that Committee's office.

HREC Forms

• Full Ethics Annual and Final Progress Report (docx)  
• LNR Annual and Final Report (doc)  

Amendments and modifications

Any amendments or modifications to an approved study must receive approval from the HREC Sub Committee. The process for amendment/modification is outlined in the Amendment Submission Requirements document below. 

• Amendment submission requirements (doc)
• Request for Amendment or Modification form (doc)

In the circumstance where a required amendment to the study only involves the addition or removal of a site and or investigator, the following form can be used instead of the full Request for Amendment or Modification Form (above). These requests will be handled out-of-session.

• Adding or Removing a Site or Investigator only (doc)

Safety reporting

Safety reporting is a condition of your ethics approval and the guidelines set out in the WSLHD Memo SAE & SUSAR Reporting below should be strictly adhered to. Information in relation to monitoring and reporting of safety for clinical trials involving therapeutic goods is also available in the NHMRC document below.

• WSLHD Memo SAE & SUSAR Reporting (pdf)
• NHMRC Australian Health Ethics Committee (AHEC) Position Statement (pdf)
• SUSAR and SAE Report form (doc)
• Six monthly SUSAR and Annual SAE Summary Report form (doc)
• NHMRC Position Statement May 2009 
• Research Proposals Involving the use of Radiation or Radionuclides (pdf)

HREC Final Reporting

One of the forms below must be submitted to the HREC on completion of the study.

• Full Ethics Annual and Final Progress Report (doc)
• LNR Annual and Final Report (doc)

RGO Forms

On completion of site involvement in a study, notify the approving HREC and forward any non-WSLHD HREC acknowledgment to the RGO with a completed Research Governance Ongoing Site Authorisation Form (docx). The file will be closed and archived.