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 REGIS, Policies and Procedures, Clinical Trial Management System

Research projects are submitted for research ethics and governance review in the NSW Health Research Ethics and Governance Information System (REGIS). Once approved, REGIS is also used for submitting progress reports, safety notification and amendments.

REGIS

External Link  Research Ethics Governance Information System (nsw.gov.au)

Quick Reference Guides (QRGs), training instructional videos, are available on the External LinkREGIS How-To page.

Policies and procedures

NSW Health Ethics and governance policies and procedures, including the NSW Health Fee Policy for Ethics and Governance Review are available External Link​ here. A method of payment form is required for all studies that incur ethics or governance review fees.

Clinical trial management system

Clinical trial management system (CTMS) information is available External Linkhe​re. ​​

 NSLHD Human Research Ethics Committee
The NSLHD Human Research Ethics Committee (HREC) is accredited to review multi-centre research projects within the following areas:
  • Population health and/or public health
  • Clinical intervention research (other than clinical trials) 
  • Clinical trials – phase II and above. 
Early phase clinical trials (or studies with a phase I component) must be submitted to External Link​Bellberry HREC​  for ethics review. Paediatric EPCTs with a NSW public health organisation site are required to be submitted toExternal LinkSydney Children’s Health Network (SCHN) HREC  for ethics review.
​
Human research ethics committee operating procedures
If you require a statement regarding the composition of the human research ethics committee (HREC) for regulatory purposes, please contact the research office.
The NSLHD HREC operates under the requirements set out by the National Health & Medical Research Council (NHMRC). All research involving humans must conform to the NHMRCExternal Link​National Statement on Ethical Conduct in Human Research (2007) and theExternal LinkAustralian Code for the Responsible Conduct of Research (2018)​.

Human research ethics committee submission
Please contact the research office one week before the submission deadline to advise of your intent to submit and to prevent unnecessary delays. Submission checklists are available to assist in submitting for HREC review. 

Ethics submission checklists and forms​:​​

Word icon Protocol template - Standard (Please use for Clinical Trials)

Word icon Protocol template - Basic (Please use for all other research)​

Word icon NSLHD Site /CPI/​PI List​​​

Word icon New application cover letter template​

Word icon New amendment application cover letter template

*Please note: Use of a waiver of consent for your study is only granted in the strictest of circumstances, in line with the National Statement and will be reviewed by the full HREC Committee if appropriate for your study. Please consult the NSLHD Research Ethics team to confirm if a waiver of consent may be applicable for your study.​

Governance submission checklists and forms:

 Committee meetings dates

​The research office coordinates the NSLHD Human Research Ethics Committee (HREC) and related committees, and the RNSH Institutional Biosafety Committee (IBC). 
New research projects and responses that require review by the full HREC should observe the submission dates below.  Low risk projects are reviewed on a rolling basis.
Please discuss submission of a new application with the research office before submitting via email [email protected]​, or phone the research office on 02 9450 7089 to arrange an appointment.

             Submission deadline

             10am

HREC Meeting date

 
Monday 06 January 2025
 Monday 20 January 2025
Monday 27 January 2025 Monday 10 February 2025
Monday 24 February 2025 Monday 10 March 2025
Monday 31 March 2025 Monday 14 April 2025
Monday 28 April 2025 Monday 12 May 2025
Monday 26 May 2025 Monday 16 June 2025
Monday 30 June 2025 Monday 14 July 2025
Monday 28 July 2025 Monday 11 August 2025
Monday 25 August 2025 Monday 8 September 2025
Monday 29 September 2025 Monday 13 October 2025
Monday 27 October 2025 Monday 10 November 2025​

 ​Fees and payments
A completed method of payment form must accompany clinical trial submissions and amendments, where the study is not sponsored by NSLHD or another PHO.
Ethics method of payment form ​​​​- PDF icon​​Click here ​to access Ethics form

 Quality Improvement and Case Reports

Quality Improvement activities may sometimes be exempt from full ethical review, however journals increasingly require formal ethical review of any research activity. The Human Research Ethics Committee (HREC) is unable to provide retrospective approval. Please contact the research office for guidance on this. 

Case reports do not require an ethics application. Please submit a cover letter outlining the background and aims of the case report and a copy of the consent form which will be provided to the patient to the research office via email [email protected]. Case reports are only considered exempt from full HREC review when they involve less than 5 patients.

Word iconClick here for a letter and consent form template.​

 ​Access requests

An access request is required to be completed for all human research projects that require access to participants, tissue or data but do not involve the conduct of research at that PHO. Access requests should be used when the project involves one or more of the following:

  • Participant recruitment through posters, leaflets, handouts and letter of invitation but not recruitment through direct contact with potential participants or enrolment (both of which require a site specific assessment);
  • Distribution of surveys and questionnaires through staff of the PHO but not collation and analysis of responses at that PHO (which requires a site specific assessment); and
  • Access to data or tissue held at the PHO but not processing or analysis at that PHO
PleaseWord icon​ click here for further information on access requests​ including how to submit an access request.​

 Perinatal Research Advisory Group
The Perinatal Research Advisory Group oversees all clinical research taking place within the Maternity services at Royal North Shore Hospital. For research conducted within Maternity services, please submit the application form to the perinatal research advisory group for review prior to Governance submission. 
For further information, please email [email protected]

 Accessing patient data for research

​Process for health information services sign-off

If a project requires records from Health Information Services (HIS), the SSA must include ‘Health Information Services’ as a department in ‘Part C’. 

PleaseExternal Linkclick here for HIS contact details.

Access to medical records can only be provided once both ethics approval and governance authorisation have been issued.


Accessing supporting departments and local department databases

After confirming support with the data custodian, add the relevant department within the SSA ‘Part C’ via REGIS.


NSLHD performance unit

The performance unit supports access to admitted patient data (eMR) or Emergency Department data (FirstNet).  A standard fee of $135.74 applies for the provision of data (additional fees may apply).

Please email the performance unit at [email protected] for a research data request application form.


eMaternity data

eMaternity is a statewide clinical database that records maternity care from booking-in, through labour and birth, discharge and community midwifery care. Researchers are required to request maternity data using 'eMaternity' database.

Please contact the data custodian for more details: [email protected] or 02 946 32177.

 Agreements and contracts

Contract and agreements
Contracts are required when a project involves a party external to NSLHD. The research office will coordinate the execution of relevant agreements as part of the governance review process. Please use the templates provided on this page. Use of other agreements is possible, however these will require legal review by NSLHD.

Confidential disclosure agreement and non-disclosure agreement
A confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) may be required if you are sharing sensitive information with a third party outside of NSLHD in planning research. Researchers should not sign CDAs or NDAs for NSLHD. 

Submission guidelines:
  1. Add the correct details, including ABN 63 834 171 987, for NSLHD.
  2. Email a Microsoft Word version of agreement [email protected].
  3. Allow 14 days for review and return.

Clinical Trial Research Agreements

A Clinical Trial Research Agreement (CTRA) is used for sponsored, non-device clinical trials. Changes to the body of the CTRA (except Schedules 4 or 7) must be reviewed and approved by the National Clinical Trial Agreements Panel (NaCTA). 

​Template CTRAs are available viaExternal LinkMedicines Australia.


Clinical Investigation Research Agreement

A Clinical Investigation Research Agreement (CIRA) is used for sponsored device trials. The body of the CIRA should not be altered. Any amendments to the CIRA are to be made exclusively via changes to Schedule 7 and reviewed and approved by the National Clinical Trial Agreements Panel (NaCTA).   

Template CIRAs are available viaExternal LinkMedical Technology Association of Australia. 
 
Submission guidelines for CIRAs and CTRAs:
  1. Add the correct details, including ABN 63 834 171 987, for NSLHD on Page 1.
  2. Add relevant wording to schedule 2 (CTRA) regarding ethics and/or governance fees (if applicable).
  3. Obtain PO number from sponsor for invoice.
  4. Email a Word version of agreement, attention RGO, to [email protected]​​, before governance submission in REGIS. 
  5. Once reviewed, Sponsor and PI will sign agreement, prior to submission of governance application in REGIS.
  6. Fully executed agreement will be returned with project authorisation. 

Investigator initiated research agreements
Investigator initiated research agreements are used when a study involves a party external to NSLHD. 
​
Submission guidelines:
  1. Add the correct details, including ABN 63 834 171 987, for NSLHD.
  2. Email a Word version of agreement, attention RGO, to [email protected], before governance submission in REGIS. 
  3. Fully executed agreement will be returned with project authorisation. 

Material Transfer Agreements
Material Transfer Agreement (MTA) can be used to transfer data, material, or samples from NSLHD to an external site, where a CTRA or other agreement is not required. Note that executing an MTA may incur a fee. Please contact the research office for more information.

The NSLHD template is availableWord icon​here.

Submission guidelines:
  1. Complete the highlighted text, do not modify the standard terms and conditions.
  2. Email a Microsoft Word version of agreement, attention RGO, to [email protected], before governance submission in REGIS. 
  3. Fully executed agreement will be returned with project authorisation. 

Clinical Trial Service Agreement
A Clinical Trial Service Agreement (CTSA) is used to purchase or have NSLHD provide a clinical trials research service for single-study use. These can not be used for ongoing service provision. 

 Indemnity, insurance, clinical trials notification and the use of logos
Indemnity 
Sponsored clinical trials require a Medicines Australia Form of Indemnity, to be provided by the sponsor.  There are two forms of indemnity available for use:

Indemnity - Standard
This is used when NSLHD provides premises for the study and requires HREC review or provides premises only. Please submitExternal Link​this form with governance application. 

Indemnity - HREC review only
This is used for NSLHD HREC Review when no participating sites are within NSLHD. Please submit this form with ethics application via REGIS.

Submission guidelines: 
  1. Add the correct details, including ABN 63 834 171 987, for NSLHD.
  2. The sponsor must sign the Form of Indemnity - HREC Review before submission in REGIS.  
  3. Fully executed agreement will be returned with project authorisation.  

Insurance
All commercially sponsored clinical trials require an insurance certificate, submitted with the governance application.

Clinical trials notification
Drugs, biological material or devices that are used in clinical trials must be registered on the Australian Register of Therapeutic Goods (ARTG) for the particular indication/use that is being studied.

Clinical trials using unapproved therapeutic goods(including medical devices) or goods that are being used outside of the scope approved by the Therapeutic Goods Administration require a Clinical Trials Notification (CTN) or Clinical Trial Approval (CTA). This is lodged by the sponsor via theExternal LinkTGA Business Services Website.Where NSLHD is the sponsor please contact the Research Office as additional information will be required for the Research Office to submit the CTN.​

Logos and sponsors
The NSLHD logo (format below) are required on all institutional patient facing documents, so it is visible for participants. Sponsor logos are not to be used on patient facing documents.External Link​Download the NSLHD logo
​

 Radiation in research
A NSLHD radiation research study request form needs to be submitted involving the exposure of humans to ionising radiation must meet the requirements of the Code of Practice for the Exposure of Humans to Ionizing Radiation for Research Purposes (2005) (ARPANSA Radiation Protection Series No. 8).  Ethics and governance processes for research involving the exposure of humans to ionising radiation must be followed.

Ethics submission guidelines
  1. NSLHD RadiationExternal Linkresearch study request t​o be submitted to the NSLHD Radiation Safety Officer (RSO) [email protected].
  2. Once the Radiation research study request has approved by the RSO, submit the following via REGIS with the HREC application:
    • the RSO-approved NSLHD radiation Research Study Request;
    • a copy of the imaging manual specifying the manner in which any imaging is to be provided (if available);
    • the radiation dose assessment and risk assessment obtained from a medical physicist (if available), and;
    • the written information to be given to research participants relating to the doses and risks associated with the radiation exposure.

Governance
Investigators conducting research at a NSLHD site involving the use of ionising radiation must follow one of the below.

When the radiation use does not exceed standard care
The principal investigator must complete and sign aExternal LinkRadiation in Research N​otification form and submit this to the research governance office with the governance application in REGIS.

 External researchers coming to NSLHD

The NSLHD Principle Investigator is responsible for completing and submitting all documents relating to the set-up of external researchers.  More information about establishing contingent research workers can be found by NSLHD staffExternal Linkhere.​

 Institutional Biosafety Committee
​The Gene Technology Act 2000 regulates the use of Genetically Modified Organisms(GMO) in Australia. Researchers undertaking any experiment involving involving GMOs as defined by the Act​ the construction and/or propagation of viruses, prokaryotic or eukaryotic cells or organisms of novel genotype, must obtain the approval of the Northern Sydney Local Health District Hospital Institutional Biosafety Committee (NSLHD IBC).

Details about the Gene Technology Act, GMOs, Storage and Certification requirements and more can be found on the External Link​Office of the Gene Technology Regulator (OGTR) website.


Standard forms for IBC submissions:

The following forms are required for all submissions to the Committee:

  • Submission Deadline (12pm): 26 October
  • IBC Meeting Date: 5 November​


​Contact us if you have any questions


The research office can answer any queries related to the conduct of research.

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