Submit

Returned · resubmitting as v2 VH-2026-0046 · Signed in as Principal Investigator

MB-TSLP-002 · A Phase 1, First-in-Human, Randomised, Double-Blind, Placebo-Controlled Study of MB-TSLP-002 in Healthy Adults

Setup

✓Personnel ✓Study sites ✓Sponsor

Application

✓Rationale ✓Participant population ✓Ionising radiation ✓Risks and indemnity ✓Ethics committee ✓Declarations !Attachments

Finish

→Submit

Submitting before Thursday 12 November, 5 pm AEDT puts this on the 18 November agenda. Comments usually arrive within 2 business days of the meeting.

1 · Completeness1 item blocks submission

✓

Setup Personnel, Study sites, Sponsor complete. Site listed as Northside Clinical Research Unit; both locations described.

✓

Pages 1 to 6 61 of 61 questions answered. Return notes 1 and 2 addressed on pages 1 and Study sites.

Page 7 · Radiation safety report missing Required because page 3 declares imaging above standard of care (return note 3). Attach the medical physicist's report, or change page 3 if the chest X-ray is standard of care.

Fix

Page 7 · Optional research PICF not attached Page 1 says the study has optional objectives. You can submit without it, but the committee will ask.

Fix

HREC Indemnity awaiting Vial HREC countersignature Signed by Meridian Biologics on 3 Nov. Vial HREC signs in-portal after submission; this does not block you.

✓

Changes since v1 4 answers edited, 2 documents replaced (tracked + clean attached), 1 person added. The committee sees a change summary with your resubmission.

2 · FeePaid 3 Nov · no charge to resubmit

New study, higher-risk review, single site[FEE]

GST[GST]

Total paid, AUD[TOTAL]

Paid by card by Lena Park (sponsor contact). Tax invoice INV-2026-0611 issued to Meridian Biologics Pty Ltd, Accounts Payable. Amendments and reports are invoiced on submission and payable here or by EFT within 14 days.

3 · Principal Investigator attestationOnly the PI can complete this step

I have read and agree with the information in this application, and I will conduct the study according to the documents approved by the HREC, the National Statement on Ethical Conduct in Human Research, ICH-GCP and all other relevant legislation, policies and guidelines, including Vial HREC policies and guidance. I am responsible for ensuring site-specific research governance approvals are complete before the study commences, and I acknowledge that this submission may be subject to fees in the Vial HREC fee schedule.

Dr Priya Raman, MBBS FRACP

Signing as Principal Investigator · priya.raman@northsidecru.org.au · recorded with timestamp, IP and account in the application history

← Attachments

Enabled once the blocking item and both attestations are done

What happens next

Administrative check, within 2 business days. Anything missing comes back as return notes you answer in the portal.
Assigned to a committee and a meeting date; you get an email and the status changes to Under review.
Committee comments within 2 business days of the meeting; answer each one inline, with updated documents. Responses are due within 6 months.
Decision. Approval letter is generated under this record and emailed to everyone on the Personnel page.

Typical time to decision21 working days

Snapshot

On submit, the application and all 11 attachments are frozen as v2 and filed under the record. Nothing is editable until the committee returns it or sends comments.

Preview v2 as PDF