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Returned VH-2026-0046 · Last saved just nowMB-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
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Return note 3: Page 3 says a screening chest X-ray is used, so a site-specific Medical Physicist's Report is required (Vial HREC G13). Expected under "Radiation safety report" below.
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The document type, version and date are read from the file name, [Protocol]_[Type]_v[Version]_[DDMonYYYY], and shown for you to confirm. Searchable PDF with bookmarks for the Protocol and IB. Up to 100 MB each.
Expected for this application · 9 of 11 attachedWhy these?
| Document type | File | Version | Date | Check |
|---|---|---|---|---|
| Protocol | MB-TSLP-002_Protocol_v1.0_02Nov2026.pdf | v1.0 | 02 Nov 2026 | Searchable, bookmarked |
| Investigator's Brochure | MB-TSLP-002_IB_Edition1_15Oct2026.pdf | Ed. 1 | 15 Oct 2026 | Under 12 months |
| Master PICF Pathway 1 | MB-TSLP-002_Master Main PICF_v1.0_02Nov2026.docx | v1.0 | 02 Nov 2026 | Clean |
| Optional research PICF | Expected because page 1 says the study has optional objectives. | |||
| Curriculum vitae PI, under 2 years old | Raman_P_CV_Oct2026.pdf | Oct 2026 | Check PI experience | |
| HREC Indemnity | MB-TSLP-002_HREC Indemnity_Meridian Biologics.pdf Signed by sponsor 3 Nov · Vial HREC countersignature requested in-portal | 03 Nov 2026 | Awaiting Vial HREC signature | |
| Conflict of interest management plan | MB-TSLP-002_COI Management Plan_v1.0_30Oct2026.pdf | v1.0 | 30 Oct 2026 | Attached |
| Radiation safety report Medical physicist | Expected because page 3 declares imaging above standard of care. Return note 3. | |||
| Advertising | MB-TSLP-002_Social Media Ad Set_v1.0_28Oct2026.pdf MB-TSLP-002_Recruitment Flyer_v1.0_28Oct2026.pdf | v1.0 | 28 Oct 2026 | 2 files |
| Other participant documents | MB-TSLP-002_Symptom Diary_v1.0_28Oct2026.pdf MB-TSLP-002_Wallet Card_v1.0_28Oct2026.pdf | v1.0 | 28 Oct 2026 | 2 files |
| Any other material for the Committee | MB-TSLP-002_Extended Study Summary_v1.0_02Nov2026.pdf MB-TSLP-002_SRC Charter_v1.0_02Nov2026.pdf | v1.0 | 02 Nov 2026 | 2 files |
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Not accepted here: cover letters, protocol signature pages, insurance certificates, standard indemnities, medical registrations, Sub-Investigator CVs, notes to file. They stay in the site file.