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Malina Peng, Logan Lown, Andrea Lee, Jessica GrundyResearch Directorate
SWSLHDREGIS Training
Frequently Asked Questions
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New Terms in REGIS
Application = Pre approval
Project = Post approval
HREC Reference # = 2019/PIDXXXXX
Ethics Reference # = 2019/ETHXXXXX
Site Specific Reference # = 2019/STEXXXXX
Submit Project Registration to get access to Ethics and SSA.
Edit Access
CPI will be able to give application access to team members to draft the HREA and SSA forms. NOTE: CPI and PI must submit the final forms in replacement of physical signatures.
Common issues, mistakes and omissions
• Contact the Research Office before submitting your application – we are happy to pre-review your draft protocol via email, and meet if necessary.
• Review your attachments to ensure there are no grammatical and spelling errors, etc.
• Ensure all documentation have title of document, version number and date.
• Don’t forget to complete your SSA after your HREA.
Migration issues
Check with CPI account for project – if project is not there, contact REGIS to merge accounts.
If project is still not there, contact the relevant Governance Office.
Coordinators: you should see your existing projects – if not – check with CPI, ask for edit access.
Head of Department - issues
Known bug – If HOD supports with conditions, then status will change to HOD not supported. Please call the office and we will be able to override this issue. If the department you are looking for is not listed, please also contact the office to add the department to the list with person
There will be an enhancement to the system coming up in the next few months so that these known bugs will be fixed. It will also enable a HOD supported SSA to be submitted directly to the RGO without resubmission from the PI.
ETHICS – Status Flowchart1. Submitted when you submit the HREA.
2. Eligible / Ineligible after administration checks are done.
3. If ineligible, follow QRG – Ineligible Notification – Resubmitting Application. The HREA will then go back to submitted.
4. Under Review/Assigned to meeting when the HREA is with the Ethics Committee for review.
5. If further clarification is needed, HREA will be Information Requested . Please note that we require a response cover letter and updated documents in tracked and clean.
6. To submit further information, follow QRG: Responding to a Request for Information – Initial Application. Status will become Information Provided. This means it is with our office.
7. If the application is ready for approval as deemed by the Ethics Committee, the HREA will be Approved. You will receive an approval email via REGIS.
SSA – Status Flowchart1. Submitted when you submit the SSA.
2. Eligible /Ineligible after administration checks are done.
3. If ineligible, follow QRG – Resubmit a new version of the application after an ineligible notification. The SSA will then go back to submitted.
4. If further clarification is needed, SSA will either be Information Requested. Please note that we require a response cover letter and updated documents in tracked and clean.
5. To submit further information, follow QRG: Responding to a Request for Information – Initial Application. Status will become Information Provided. This means it is with our office.
6. If the application is ready for approval as deemed by the Research Ethics Office, the SSA will be Authorised. You will receive an authorisation email via REGIS.
REGIS Profile How much information is required?
As much information as possible as this replaces the CV.
The REGIS Profile links to ORCID and you are able to list employment details, education, qualifications etc. The purpose is to show how much research experience the person has to support the SSA.
If we cannot see that there is enough detail in the REGIS Profile to provide an adequate background of research experience, we will ask for the CV.
Example of REGIS Profile layout – next slide.
Heads of DepartmentsWhat happens if there is an Acting Head, either short term or long term? Do they need to inform you or have all departments have Heads and Acting Heads setup in REGIS? All HODs should inform the Research Directorate if they
are going on leave, and who their Acting is. If we know early, we can communicate this to the REGIS Team to organise the Acting to be set up in REGIS during those specific dates of leave.
If we don’t know, we cannot do this. Please let us know!
NSW Health have not allowed Acting HODs to be accessible in REGIS at all times. They are written into the background, but the REGIS Team needs our office’s notice to make the Acting ‘live’.
Please confirm that Study Coordinators/ researchers can set up application (HREA/SSA) but the CPI or PI needs to make the actual submissions. Yes. This is a NSW Health mandatory requirement.
Why? NSW Health’s position is that as physical signatures have been replaced by electronic declarations, they need the CPI/PI to submit all official paperwork in REGIS to the Research offices.
Do documents attached have to be titled in a particular way? The provided field within REGIS does not allow you to title the document correctly. We are aware that there are only 8 characters available to name
the document in REGIS. We advice that you therefore name the documents as ‘Protocol’, ‘PIS’, ‘PISCF’, ‘CF’, ‘Brochure’, ‘Flyer’, etc. This will help everyone organise the documents in REGIS.
The important part is naming your PDF / Word FILE name correctly, i.e. Protocol, version 1, 1 January 2019 and to ensure this is reflected accurately in the footer of the document.
You can also put a number in the file name to correspond with a cover letter, if you wish, i.e. “1. Protocol, version 1, 1 January 2019”.
Please clarify which date is used when uploading a document. Dated of the upload or date of the document? This has not changed – we always use the date
of the document as reflected in the footer.
What format do the documents need to be in i.e word or PDF?
Either. This has not changed.
What happens if a CPI or PI (e.g. Masters or PhD student or Fellow) leaves a unit and is uncontactable, how is the study able to be transferred or closed?Note this often occurs if Fellows come from overseas to work in a unit and leave before these matters are sorted out
This process has not changed – we expect that ‘old’ CPI/PI to communicate this to the Research Directorate before their departure and submit an Amendment in REGIS for change for CPI/PI (details provided shortly).
However, if in extenuating circumstances, the Research Directorate can assist. Please contact us.
Overview of NMA process a) NSW/ACT sites can send SSA to other states’ sitesb) SSA sent from other states to NSW/ACT sites
a) You can download the HREA, Master Documents and Ethics Approval from REGIS and upload into the various system that the other state uses. Please speak to the relevant Research offices in the other states for more information.
b) Please refer to NMA quick reference guide.
National Mutual Acceptance (NMA) in REGIS
NMA QRG – if HREC is outside NSWPlease complete National Mutual Acceptance (NMA) in REGIS for when another state is the lead HREC for the study.
IMPORTANT: Make sure you upload all supporting documents such as ethics application, HREC approval letter, amendment approvals, MASTER documents and any other supporting documents.
Please note that Northern Territory and Tasmania are not part of NMA. Please contact their Ethics offices directly for further information.
If there are urgent issues such as suspension of a study due to SAE or lack of efficacy, do we need to contact HREC verbally or by email to highlight that you have uploaded the documentation into REGIS? This process has NOT changed.
Please do not advise the Research Directorate verbally –this must be, as always, documented in writing.
Please follow the NSW Safety Guidelines and submit in writing immediately to the HREC via email.
We will let you know when REGIS is able to accept safety notifications such as SUSAR, SSI, Annual Safety Reports, Serious Breaches, etc.
When REGIS sends an email to the HOD can they see the SSA and associated documents?
Yes, they can download the entire application to review before they provide their support.
Can you upload the CTRA in section 2 of the SSA? There are concerns over HODs seeing budgets and other confidential information relating to the trial. After HOD support, you are not able to upload further
documents, as the expectation is that the SSA cannot be changed after HOD has provided support.
Why is Braeside Hospital not added on the REGIS system? It is a part of SWSLHD? Braeside Hospital is not within SWSLHD jurisdiction.
Braeside falls under HammondCare.
Please speak directly to Braeside for their SSAs.
Please also speak directly to Braeside as to why they are not part of REGIS. SWSLHD and all other public LHDs agreed to be part of REGIS with NSW Health.
SWSLHD Sites Bankstown Lidcombe Hospital
Bowral and District Hospital
Camden Hospital
Campbelltown Hospital
Fairfield Hospital
Ingham Institute for Applied Medical Research
Karitane
Liverpool Hospital
NSW Office of Preventive Health
NSW Service for the Treatment and Rehabilitation of Torture and Trauma Survivors (STARTTS)
South Western Sydney Local Health District (Site)
SWSLHD Community Health Centres
How do you manage a project in REGIS with a private site? Private sites are not included in REGIS – this is as per
NSW Health requirements. This has not affected the process for private sites.
Only NSW Health public sites such as SWSLHD are included in REGIS.
The process for private sites has not changed. SWSLHD HREC would still require an EEA – we can still provide Ethics. However, as before, please speak to the private site directly regarding their Research Governance requirements (if any).
How do you manage site documentation for sites listed in other states if you are the Lead Site with HREC approval in SWSLHD This has not changed – please manage as you would have
before REGIS.
REGIS is a platform to allow researchers, HOD, HREC Committee and the Research Directorate to view and process applications in one place.
Please liaise directly with the Research Governance Office in the other state for their requirements.
How can we manage PIs who refuse to submit annual reports/amendments in REGIS causing lengthy delays? Is there an option to override the PI so the coordinator can submit on their behalf? No. There is no option to override PI / CPI.
Please note that Annual Reports are to be submitted in the old way using the existing SWSLHD Annual Report form and emailed to [email protected].
Please note that the requirement for CPI to sign the Annual Report has not changed – therefore when the Annual Reports will be submitted in REGIS in the future, the process has stayed the same, except that a physical signature is not needed, but their electronic declaration (submitting the Annual Report).
Please explain the different types of amendments in REGIS
Ethics Amendment Types in REGIS
Different forms for different purposes and/or requiring change in system.
Amendment – Change PI/CPI
Self-explanatory – use only for changing PI/CPI of a study.
NOTE: Only the existing PI/CPI can submit this form (to provide authority for the change of responsibility in absence of signatures on REGIS).
If there are issues with contacting the PI/CPI to conduct this change in extenuating circumstances (i.e. unexpected leave, illness, etc.), please contact the Research Office so that we can assist.
General Amendment:Addition of Investigators for ETHICS
Documentation required:
All clinical trials – GCP certification(valid for 3 years)
Make sure REGIS Profile is completed!
Non-NSW health employees:
Criminal Record Check – if working on site (valid for 12 months)
Confidentiality Statement
Addition of Investigators for SSA where we are NOT LEAD HREC
REGIS does not have functionality at this time for SSA Amendments.
This means if SWSLHD is not lead HREC for your project, you are unable to submit an amendment to add an investigator to a SWSLHD site in REGIS.
Please submit Addition of Investigator using the old method (i.e. Addition of Investigator form from SWSLHD Research website and submit via email to [email protected] )
If you are unsure, contact us
Things that have not changed
Decision Aids
MC Amendments
Annual Reports for now, as the REGIS form is not ready.
Safety Reporting (Protocol Violations/Deviations, SSI, etc.)
Addition of Investigators for SSAs where SWSLHD is not the lead HREC)
Access Request
Authorised Prescriber
How are safety reports being managed for CTN clinical trials in REGIS? This has not changed – please submit via email to
[email protected] in accordance with the Safety Guidelines.
How are Annual reports being managed? Are we using the REGIS template or do we need to still use the template in the Ethics website? Please use the existing Annual Report form and submit via
email – the old way.
Please confirm that all MC amendments are processed?
This has not changed – please submit with the MC Cover Letter via email to [email protected]
Do you need to be advised on sub Investigator involvement in a clinical trial? If not how are you managing the GCP/CV requirement? Yes – this has not changed.
Any sub-investigators at SWSLHD needs to be added via Addition of Investigator.
GCP Certificates are mandatory for all investigators in a clinical trial.
If the Addition of Investigator is for a SSA only, then yes we need the CV, as you will need to use the existing old way to Add an Investigator (via email).
If you are adding an investigator and we are also lead HREC, you are able to do this via a General Amendment in REGIS. In this case, we won’t need the CV if the REGIS Profile is up to date.
How can we move back to having single SWSLHD SSA approval? E.g. some studies are open at CLT, LIV, BNK but only use LIV radiology facilities but we cannot select LIV Radiology HOD support for CLT and BNK SSA. Please advise on the best process. In this scenario, you will need to submit separate SSA.
NSW Health has increased the restrictions of circumstances where it is possible to do a district SSA.
For Clinical Trials where only one hospital’s facilities are used for other hospitals, this needs to be reflected in the individual SSAs.
Please speak to the Research Directorate before you submit so that we can discuss further as these circumstances are usually individual to the study.
Is there a particular browser that is preferred when using REGIS? The REGIS platform is slow and unreliable. We have been advised the Google Chrome or Internet
Explorer are preferred.
Current technical issues which cannot be solved within 24 hour basis are holding up ethics/governance applications – if so could we submit via email while issues are being solved No. We are not able to process any ethics or SSA
applications outside of REGIS.
If you are having issues with REGIS, please ensure that you call the REGIS Helpdesk and also call our office if you have not heard a response from them.
We have been helping researchers with any delays to the best of our ability.
Is there a way to auto-populate the Data custodians for individual site SSA’s – we have had instances where investigators have missed adding the data custodian and only realised after submitting. No. It is the research team’s responsibility to liaise with all
relevant HODs and include them in the SSA paperwork in REGIS.
Following the initial approval of the CPI/PI why all subsequent submissions can’t be approved by the coordinator? Many coordinators are delegated by the PI to manage all Ethics and Governance submissions in line with ICH GCP. The need for PI signoff at every time point is causing unnecessary delays and increased frustration from sites and Sponsors. Can this be reviewed and modified to reflect the “real-life” situation? As stated previously, this is a NSW Health Mandatory
Requirement. This has replaced physical signatures. It is the PI / CPI’s responsibility under the Australian Code for ethics and research governance applications.
If you have feedback, please send directly to OHMR. We are obliged to follow NSW Health policy.
As we cannot see the progress of the SSA application i.e. we have no way of knowing which HOD has signed off, how best can we chase up the projects progress?
When you login to REGIS, you should be able to see the status of your project at any stage. Please select the relevant SSA and select ‘Decisions’. You will be able to see which HOD you have selected and their responses / pending.
When a protocol amendment is processed through REGIS, who is notified? If the PI’s are the only ones notified there can be delays in executing the amendment. These delays notification can result in non-compliance.
By default, all REGIS communication goes to the PI.
As a study team member that has access to the project, you are able to log on and check the status of the application to see if it is still with the Research Directorate or with the study team:
AMENDMENT STATUS:
- Submitted means with the Research Directorate
- In Progress means with Study Team
- Approved / Not Approved
Who do I contact? Research DirectorateFor: for assistance with registration, applications, and post-approval/authorisation matters such as: information/documents you need to include, missing or incorrect dep’t information (site-governance applications), and how to use REGIS (non-technical).Location – Level 2 UNSW clinical School – Liverpool Hospital E-mail: [email protected]: http://www.swslhd.nsw.gov.au/ethics/Phone: 02 8738 8304
REGISFor: technical queries such as system issues or faults, and account access issues. The Help desk is available 7am-7pm Monday-Friday, excluding ACT Public Holidays.Email: [email protected]: https://regis.health.nsw.gov.au/Phone: 1300 073 447
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