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GENERAL INFORMATION & PREVIOUS UPDATES

Biostatistical Support

 

Biostatisticians from the NHMRC Clinical Trials Centre (CTC) will be onsite at Royal North Shore Hospital for a full day each fortnight to provide support via consultations. 

To make use of this free consultation service, please email the Research Office​.

Please see 2019 dates.

External researchers conducting study activity on at NSLHD

The NSLHD Research Governance Office now requires additional information for any person external to NSLHD who intends to come onsite and conduct study activity. Further information can be found on our External Researchers page

SSA and LNRSSA checklist

To better guide applicants of the NSLHD Governance submission requirements a third page has been added to the SSA Checklist (Northern Sydney Local Health District Annexure to the Checklist).

Items now included on the checklist are:

  • Method of Payment Form
  • Cover letter
  • External Researcher​​

Annual Progress Report to Institution

All human research projects conducted across the NSLHD are required to submit an Annual Report to Institution by 30 August every year.

Reports MUST be submitted using the Annua​l/Final Report template​ on this website. It is not acceptable to simply provide a clinical summary from a trial sponsor or other written correspondence. For studies that are closed, ALL SECTIONS of the report must be completed (including section E).

Please note that the submission of an annual progress report is a condition of ethics and governance approval. The responsibilities of the investigator with regard to monitoring and reporting are outlined in the National Statement for the Ethical Conduct of Human Research – Section 5.5.5) and ICH-GCP Note for Guidance on Good Clinical Practice – section 4.10.

Investigators only need to submit one progress report to the Research Office for projects approved by the NSLHD HREC.

For projects where HREC approval was received from another Lead HREC then a copy of the most recent annual report reviewed by the HREC is required, a report is also required on the research activity component conducted at the NSLHD.

The Research Office will not send individual reminders when reports are due, however, a notice will be circulated via the Kolling email and NSLHD Area Communications email to all NSLHD. PLEASE NOTE – it is the responsibility of the researcher to submit annual progress reports.​

Electronic Signatures on documents submitted for HREC and Site Specific Assessment Review

Researchers are able to electronically sign their HREC and SSA application i.e. wet ink signatures are no longer required. One hard copy of the full application is still required. In addition, the complete application must be emailed to NSLHD-research@health.nsw.gov.au per the instructions in the submission checklist. When emailing the application to the research office, please also copy the Coordinating/Principal Investigator.

Please refer to the Research Office website for further information on how to submit research projects for HREC or SSA review and approval.​

Requesting copies of older documents from files​

Requests for older study documents from researchers with studies that are being monitored or closed out, and the site file is incomplete must be made with a minimum of 48 hours' notice to access the file. Researchers are required to come to the Research Office to make copies of any documents. If you only require one or two documents, please contact us to discuss requirements.

In order to arrange to view a file:​

1.       Email NSLHD-research@health.nsw.gov.au with the subject line

"Access to study file requested – NSLHD reference XXX"

2.       The body of your email should list the full study title (not just the sponsor acronym), and all known NSLHD reference numbers.

3.       On receipt of your email, the Research Office will advise when the file will be available, and provide a window of time that it will be held for you to come and make copies.

NB. For multi-volume studies or studies with many associated SSAs, the file may not be available within 48-hours; however you will still be given a timeframe for availability.

4.       Please note if the request is being placed by a coordinator or investigator who is not named in the study documents (e.g. In the NEAF/SSA/protocol) we require written confirmation from the Principal Investigator that the requester has appropriate authority to access the study documents.

If you have any questions on the above changes, please contact the Research Ethics and Governance Team on 9926 4590. ​​​​​​​​​