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REGULATORY INFORMATION

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Certified Clinical Trial Sites

Medsafe administers an approval scheme for clinical trials under Section 30 of the Medicines Act 1981. Further information about this scheme can be found in the Guideline on the Regulation of Therapeutic Products in New Zealand - Part 11: Clinical Trials - Regulatory Approval and Good Clinical Practice Requirements (see http://www.medsafe.govt.nz/regulatory/guidelines.asp).

One component of the clinical trials scheme is the self-certification of sites that have study participants in residence while the clinical trial medicines are administered. Further information about the self-certification scheme can be fount in Section 4 of the Guideline.

The following is a list of sites for which self-certification has been lodged with Medsafe.

Last updated: 21 February 2012

Name of Site Address Contact Person
Auckland City Hospital 3 Park Road
Grafton
Auckland
Tanya McWilliams
Auckland Clinical Studies Ltd Ground Floor, ECOM House
3 Ferncroft Street
Grafton
Auckland
David Cranna
Capital & Coast District Health Board Clinical Trial Unit Level 8, CSB Building
Riddiford Street
Newtown
Wellington 6021
Marina Dzhelali
Cardiology Clinical Trials Unit Cardiology Department
Waikato Hospital
Pembroke Street
HAMILTON 3205
Liz Low
Children's Haematology/Oncology Centre Christchurch Hospital 2 Riccarton Avenue
CHRISTCHURCH 8140
Jenny Gardner
Christchurch Clinical Studies Trust Ltd 31 Tuam St
Christchurch
Richard Robson
Clinical Trials Unit, Clinical School Tauranga Hospital P O Box 12024
Cameron Road
Tauranga 3143
Rana Reuther
Department of Anaesthesia + Perioperative Medicine , Auckland City Hospital 3 Park Road
Grafton
Auckland
Kerry Gunn
Department of Anaesthesia Research, Auckland City Hospital Level 8
Room 83-080
Grafton
Auckland 1010
Davina McAllister
Department of Intensive Care, Christchurch Hospital Riccarton Avenue
Christchurch
Jan Mehrtens
Dunedin Hospital 201 Great King Street
DUNEDIN
Pamela Jackson
ICU, Hawke's Bay Hospital Omahu Road
HASTINGS
Ross Freebairn
ICU, Waikato Hospital Pembroke Street
Hamilton 3204
Annette Forrest
Inpatient Wards 61, 62 and 63, 64 Auckland City Hospital 2 Park Road
Grafton
Auckland
Jane Wylie
Middlemore Hospital Private Bag 93311
Otahuhu
Auckland 1640
Edward J Gane
Middlemore Hospital Private Bag 93311
Otahuhu
Auckland 1640
Stephen J Gerred
P3 Research Limited First Floor
121 Adelaide Road
Newtown
Wellington 6021
Dean R. Quinn
P3 Research Limited Suite 11, Promed House
71 Tenth Avenue
TAURANGA
Katie Kennett
Paediatric Haematology/Oncology Unit, Starship Children's Health Park Road
Grafton
Auckland
Sarah Hunter
Primorus Clinical Trials Limited P O Box 25081
Ground Floor
40 Stewart Street
Christchurch 8011
Alison M. Luckey
Sleep Unit, Department of Respiratory Medicine 1 Riccarton Avenue
CHRISTCHURCH 8011
Sue Teague
Zenith Technology Corporation Ltd P O Box 1777
DUNEDIN
Cheung-Tak Hung