Archives: <span>FAQs</span>

All Updated Documents: File names for updated documents should include:

(I, the undersigned)

Understand that once any of the image(s) referred to above have been published, the researchers have no control over subsequent use and disclosure of the images; the images will be in the public domain, and it will not be possible to revoke consent.

Understand that I can withdraw permission for the further use of my image(s) at any time.

Annual/Progress Reports
A site-specific MAR F4.1.1 Progress Report form must be completed by each site and included in the Milestone Annual/Progress Report submission in REGIS.

Lead Site in REGIS:

Multi-centre site in REGIS with lead site in REGIS:

Multi-centre site in REGIS with lead site in eProtocol:

Ethics approval expiry
Ethics approval will expire on the day of the approval end date. The Annual/Progress Report in REGIS should be submitted with the MAR F4.1.1 Progress Report form prior to the ethics approval expiry date to allow time for review and approval.

If there are any issues with submitting the Annual/Progress report in REGIS prior to the ethics expiry date, please contact the EPCT team at EPCT@bellberry.com.au.

If ethics approval expires, researchers must ensure:

Final Milestone Reports
In addition to the REGIS Milestone Final Report submission, a site-specific MAR F4.1.2 Final Report form must be completed by each closing site and included in the submission.

Lead site in REGIS:

Lead site in eProtocol:

Guidance
Please see the below link to the Bellberry progress and final report guidance document:
MAR G4 Progress and Final Reports

For information on how to submit a Milestone in REGIS, refer to the below QRG:
Submitting Annual Progress or Final Report (Milestone)

For further REGIS guidance, please refer to the following link to the Quick Reference Guide web page: https://regis.health.nsw.gov.au/how-to/

Bellberry Education Evening’s

Professor Ian Frazer AC, Thurs 9 November 2017, Adelaide

Navigating the murky waters of data banks & registries and application of the National Statement

Liddy Griffith and Professor Annette Braunack-Mayer
Thursday 27 July 2017

For further information regarding applications please contact: epct@bellberry.com.au

Under the EPCT Framework Senior Executives and/or Research Directors from NSW PHOs that are included as part of an application will be invited to attend the HREC meeting during the period the application will be considered by the Committee at a HREC meeting. The nominated Observer can nominate to attend in person or remotely.

Non-commercially sponsored, investigator-initiated research applications submitted by NSW PHOs under the NSW EPCT framework may be eligible for a Bellberry fee reduction and NSW OHMR HREC fee subsidy support. Please contact the Bellberry EPCT team to discuss.

Multi-centre EPCT applications, which will include a NSW PHO, can be reviewed by Bellberry under the NSW Early Phase Clinical Trials (EPCT) Framework with applications made via the following submission pathways:

1. Lead submission is from a NSW PHO – the lead application must be made via REGIS. Private institutions may be included as part of the REGIS application, either in the initial submission or via an amendment, or an application can be submitted directly to Bellberry via our eProtocol platform.

2. Lead submission is from a private institution – where this application has been received via eProtocol, application(s) for NSW PHO’s can be made via eProtocol or REGIS.

Please note the following guidance for submissions made via;

Please note the guidance for the following HREA registration and application questions:

Project Registration A1. Has the project ever received ethics approval or has an ethics application from ever been submitted to an NHMRC registered HREC, for the project? Answer NO so that a HREA application is generated.

HREA Q1.13 Has this research project had prior ethics review? Answer YES. Provide the application ID for the lead site application.

In either circumstance, a lead site can submit amendments or notifications to Bellberry on behalf of all approved sites during the lifecycle of the study.

Please note: each site is required to provide a site-specific annual Progress (Milestone) report. When applicable, such as when the lead site submission is via a platform other than eProtocol, the lead site can submit a collection of additional site Progress (Milestone) reports. Following site closeout, each site is required to provide a site-specific Final Report. Please refer to MAR G4 Progress and final reports and MAR F4.1.1 Progress report (eProtocol questions) for further information.

New applications on behalf of NSW PHOs, which have not previously undergone a Bellberry review, must be submitted via REGIS.

In addition to Bellberry’s submission guidance, please review and include the information in the REGIS application checklist or include the completed checklist with your application.

Please only submit electronic indemnities listing sites that have applied or are due to apply in the coming days. Bellberry will not execute indemnities that list sites that have not applied eProtocol.

If the indemnity is on paper, Bellberry will strike through the sites that haven’t applied in eProtocol.

The lead site only needs to choose a pathway. There may be some situations where updated documentation is required, but it should be rare.

For example, if they pick pathway 2, they do not need to send in site-specific clauses documents if we have already approved their site-specific PICF. Sites approved before the PICF pathways only need update the HREC with a site-specific clauses document if they are changing the wording from an already HREC approved site-specific PICF.

If the lead site chooses pathway 3, the only update required is if the Master PICF does not cover the requirements of the additional site that is being added. E.g. the radiation statement has two options, but the new additional site has different wording that isn’t already covered. The lead site would then need to submit an amendment with an update to the Master PICF. The amendment can come either before or after the additional site is approved. If it comes post-approval, the additional site will be delayed in creating its site-specific PICF. This is a matter for Sponsors and sites to work out what suits them best.

Please contact the Sponsor and get them to confirm with the site that submitted the initial application (lead) which pathway they would like the study to follow. Once you have confirmation, please attach any email correspondence that confirms the pathway and upload it with your application. If there is no correspondence, the HREC administrator will need to contact the lead site and ask which will potentially delay approval for the additional site.

The HREC administration keeps a record of the lead site’s PICF pathway at the initial submission. If a site tries to change the pathway, the HREC administration will return the documentation, along with an explanation that it does not match the study pathway. The only exception to this would be when a single centre study on PICF pathway 1 has changed to a multi-centre study. The Sponsor needs to determine who is responsible for unpacking the PICF and moving the study to PICF pathway 2 or 3. In this case, the submitting site should also explain the change in the pathway to the HREC. Providing as much information as possible will help the administrator understand why the documentation change is being submitted.

The BB website lists the FAQ below:

“If I have an additional site what do I need to submit and when?”

“If the lead site has yet to be approved please submit your site application via eProtocol, however you do not need to attach any study documentation on page 7 of your application. If your lead site has already received HREC approval you will need to submit a full application including all your site’s study documentation on page 7”

 In this context, we define ‘full application’ to mean each site must complete an application in eProtocol and answer all questions. We don’t wish for the definition of ‘full application’ to relate to the uploading of core study documents such as the protocol, IB etc.

The additional sites are only responsible for uploading documents relating to them. The sort of items we would expect to see uploaded:

No. It only holds up the site/s in question. Suppose it is something minor that could be dealt with swiftly. In that case, we will encourage our team to rectify the issue so approval for all sites can occur on the same day. If it appears that is not likely, sites 1 & 4 would be approved. Then, sites 2&3 would be approved when they have resolved their issues. Sites 2&3 are then provided with any approval letters that have been issued for the other sites if there are documents on there that are relevant to them (e.g. protocol, IB, Master PICF).