Help Desk & FAQs
Type in key words to filter and search for a subject, if you cannot find the response contact the REGIS support specialist via REGIS@health.nsw.gov.au
How to withdraw an In Progress application
Audience: Research Office
Instructions:
- Click on "Applications" from the left-hand menu (or infinity icon in the top left-hand corner, then "Applications") and then select "Search"
- Put in the application reference number in the top search box i.e. 2019/STE12345 and click "Find"
- Select the checkbox of the application from the search result and at the top of the screen select "Update Status"
- Select "Withdrawn" from the "Status to apply" dropdown menu, select the current day you are changing the status from "Status date to apply" and in the "Reason" free text box, type in the reason why this application is to be withdrawn
- Click "Apply status" to complete the status change
Tip: Rather than searching for a single application, you can search for multiple "In Progress" applications using the "Application Status" filter and bulk select and change multiple statuses at once.
This short guidance video has been created to provide Research Offices with step-by-step instructions on how to Withdraw an In Progress application from the internal portal.
Project Registration Question B8 - Clinical Trial Risk Category
In REGIS, the applicant completing Project Registration is asked to assign an overall risk category for all clinical trials (question B8). This page provides additional guidance for the completion of that question, and for the use of the information for the HREC and institution.
International risk assessment guidance from the Office of Economic Cooperation and Development recommends an overall risk category is assigned to clinical trials. This categorisation is based on the:
- potential risks of the use of the investigational product/device in the trial relative to standard of care for the clinical condition
- level of clinical experience with the intervention
OHMR has expanded the scope of the risk assessment to all interventional trials. Risks should be assessed relative to the standard of care and the level of clinical experience with the intervention rather than the patients’ underlying illness or the recognised adverse effects of the intervention.
By assigning each trial with a pragmatic risk category, the institution can use this information to plan an appropriate level of oversight (e.g. to inform a trial audit plan). In addition, collection of these data will enable the institution to build an overall risk profile based on the clinical trials that it conducts.
Risk Types for Drug Trials
| Risk type | Drug Trials |
| Type A: Risk comparable to standard medical care |
Trials involving a drug entered onto the Australian Register of Therapeutic Goods (ARTG) if:
|
| Type B: Risk associated with modified use of an existing product/intervention |
Trials involving a drug entered onto the ARTG if:
Trials involving a drug not entered onto the ARTG if:
|
| Type C: Risk associated with use of an unlicensed product/novel intervention | Trials involving a drug not entered onto the ARTG. |
Risk Types for Device Trials
| Risk types | Device trials |
| Type A: Risk comparable to standard medical care | Trials involving a medical device used within the terms of its marketing approval if knowledge derived from controlled trials already exists. |
| Type B: Risk associated with modified use of an existing product/intervention |
Trials involving a medical device used:
A Type A grading may be justified if there is extensive use/clinical experience with the therapeutic good and no reason to suspect a different safety profile in the trial population. |
| Type C: Risk associated with use of an unlicensed product/novel intervention |
Trials involving a medical device not entered onto the ARTG.
A grading other than ‘TYPE C’ may be justified for therapeutic goods not on the ARTG but which have been approved in other jurisdictions and for which there is extensive clinical data.
|
Risk Types for Interventional Trials
| Risk types | Interventional trials |
|---|---|
| Type A: Risk comparable to standard medical care | The use of an established intervention in line with local or national protocols. |
| Type B: Risk associated with modified use of an existing product/intervention | Risk associated with modified use of an established intervention. |
| Type C: Risk associated with use of an unlicensed product/novel intervention | Risk associated with the use of a new/novel intervention and/or where no knowledge from prior studies exists. |
CPI/PI delegation FAQ
On Wednesday 19th October 2022, REGIS introduced new functionality that allows the Coordinating Principal Investigator (CPI) or Principal Investigator (PI) to delegate the administrative ability to submit applications and forms in REGIS. This role will be known as ‘Submit’. This access can be allocated to anyone with a REGIS user account. Anyone with ‘Submit’ access on a study will be able to complete administrative tasks such as submitting applications, responses to requests for further information, amendments, safety notifications and milestones (i.e. progress reports).
This does not remove the overall responsibility of the study from the CPI or the overall responsibility of the study at a site for the PI.
See the FAQ here: CPI/PI Delegation FAQ (includes video links to the walkthrough webinar)
