Committee feedback
Return notes and committee comments, across all your applications, answered here.VH-2026-0041 · MB-IL22-001 · Phase 1 FIH, anti-IL-22 Comments received · Cycle 1 Committee A · meeting 11 Nov 2026 · responses due 9 May 2027
Answer each comment below. Attach updated documents as tracked and clean; earlier versions stay listed. Nothing reaches the committee until you send all responses, and the committee reviews them out of session. 3 of 6 answered.
Cycle 1 · sent 13 Nov 2026 · 6 comments, all need a response
1
Dr Raman is a medical oncologist. Please explain what relevant training and experience she has to oversee this first-in-human trial for a dermatological condition, and whether she has prior experience as a Principal Investigator. Please update her CV accordingly.
Raman_P_CV_Nov2026.pdfDraft saved
2
Northside Clinical Research Unit should be listed as the site, not the locations where rooms are leased. Remove those as study sites in question 1 and in all study documents; describe activities at each location under question 2. In particular, clarify what "Consent/Screening/Late outpatients MAY occur at the CBD rooms" means in practice.
MB-IL22-001_Protocol_v1.1_14Nov2026_tracked.pdfMB-IL22-001_Protocol_v1.1_14Nov2026_clean.pdf
3
"Is medical imaging involving ionising radiation being used in the study?" was answered No, but the protocol and PICF include a screening chest X-ray. As this is above standard of care, a site-specific Medical Physicist's Report is required. See Vial HREC G13 Ionising Radiation.
Radiation safety report · not yet attached
4
Please clearly identify which staff member(s) obtain consent and sign the PICF. This responsibility must be carried out by a delegated medical doctor with appropriate knowledge and experience to explain the implications of participation.
2 more comments · Show all
3 of 6 answered · 1 document outstanding. Responses save as drafts; the committee sees nothing until you send.
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VH-2026-0046 · MB-TSLP-002 · Phase 1 FIH, anti-TSLP Returned Vial HREC Co-ordinator · 6 Nov 2026 · administrative check, before any committee review
Return notes are fixed in the application itself, then you resubmit from the Submit step. You can also reply here so the co-ordinator sees your reasoning; replies travel with the resubmission. 2 of 3 fixed.
1
Please list the applicant organisation as the site, not the leased locations, in question 1 and all study documents. Activities at each location go under question 2.
Fixed in Study sites by Sam Okafor, 7 Nov. Reply (optional):
2
Please identify the delegated medical doctor(s) who obtain consent and sign the PICF. "Qualified representative" is not sufficient.
Not yet changed on page 1. Edit the answer
3
Page 3 says No to ionising radiation but the protocol includes a screening chest X-ray. Please correct page 3 and attach a site-specific Medical Physicist's Report (Vial HREC G13).
Page 3 corrected. Radiation safety report expected under page 7; Submit is blocked until it is attached.