№ lp_2_1_02842
Official committee agenda and meeting minutes recording attendance, application review discussions, ethical considerations, and required amendments for a Phase 1 clinical trial reviewed by a New Zealand health and disability ethics committee.
Committee: NTA Health and Disability Ethics Committee
Meeting Date: 15 July 2025
Meeting Format: Videoconference (Zoom)
Zoom Details: 812 7953 3520
Chair: Ms Kate O’Connor
Quorum Status: Quorate
Apologies: Ms Catherine Garvey
Previous Minutes Confirmed: 17 June 2025
Application Type: New applications (Full review)
Ethics Reference: FULL 23158
Project Title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TERN-701 in Participants with Chronic Myeloid Leukaemia
Principal Investigator: Professor Peter Browett
Sponsor: Terns, Inc.
Clock Start Date: 3 July 2025
Key Ethical Considerations: Post-trial access to investigational medicine; prohibition of commercial termination in New Zealand; participant compensation; confirmation of funding sources; justification of pregnancy testing frequency; revisions to Participant Information Sheet and Consent Form
Decisions Recorded: Confirmation of agenda; confirmation of previous minutes; summary of resolved and outstanding ethical issues; required amendments to study documentation
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