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Returned VH-2026-0046 · Last saved 2 minutes ago by Sam OkaforMB-TSLP-002 · A Phase 1, First-in-Human, Randomised, Double-Blind, Placebo-Controlled Study of MB-TSLP-002 in Healthy Adults
1 · Rationale
Include the protocol number. This exact text appears on the approval letter. |
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| First-in-human study? * | If No, a Phase field appears here. |
| Multicentre application? * | If Yes: lead sites list every additional site and PI and choose PICF pathway 2 or 3; additional sites give the lead PI and application ID. |
| Extension of a Vial HREC-approved study? * | If Yes: original protocol number, Vial HREC reference number and reason for extension. |
| Public health site? * | If Yes: name the public acceptance pathway (e.g. NSW EPCT Framework, SA Health Research Ethics Policy, BETA). |
| New project? * | |
State whether Aboriginal or Torres Strait Islander participants or people under 18 are involved, how cultural values were considered, and the community consultation process (National Statement 4.7). Attach a longer summary on page 7 if needed. 612 / 3,000 |
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| Registered in a public register? * | |
| Optional objectives (e.g. biospecimens)? * | A separate optional-research PICF is required. Page 7 now lists it as expected. |
| Regulatory scheme * | |
| Lower-risk review pathway? * | |
Return note 2 |
Vial HREC Co-ordinator, 6 Nov: Please identify the delegated medical doctor(s) who obtain consent and sign the PICF. "Qualified representative" is not sufficient. |