Regulatory Requirements For Clinical Trials In New Zealand

Ethical and Standing Committee On Therapeutic Trials (SCOTT) approvals are required before clinical trials can be conducted in New Zealand. These two processes run in parallel.

CCST is the first Certified Clinical Trial Site with the New Zealand Medicines and Medical Device Safety Authority (MEDSAFE). read more..

CCST is responsible for applying for ethics approval from the Ethics Committees for all studies it proposes to conduct . The information that is required by the Ethics Committee includes:

  • Completed national ethics application form
  • Study protocol
  • Investigational drug brochure
  • Volunteer/patient information and consent forms
  • Indemnity Insurance certificate
  • Any advertisements
  • Investigator(s) CV

The Ethics Committee meets every two weeks and applications close two weeks prior to the meeting date. Approvals are usually obtained within 1-2 weeks of the meeting.

The pharmaceutical company is responsible for the SCOTT application for the trial. The information that is required includes:

  • Completed SCOTT application form
  • Study protocol
  • Investigational drug brochure
  • Volunteer/patient information and consent forms
  • Indemnity Insurance certificate
  • Investigator(s) CV and the investigators agreement to conduct the study

Applications are processed within 14 to 18 working days after the Ministry of Health receives the fee and documentation. Five copies of the above information are required with each application.

New Zealand Health And Disability Committees

  • The application forms that researchers must use in applying for ethical review guidelines and information on applying.

Medsafe/Standing Committee On Therapeutic Trials (SCOTT)

  • Go here then follow the following links:  Medsafe / Regulatory Guidelines and Codes / New Zealand Regulatory Guidelines for Medicines Volumes 1-4 / Volume 3 Interim Good Clinical Practice.

RMI Guidelines

  • The Researched Medicines Industry has produced a set of Guidelines on Clinical Trials: Compensation for Injury Resulting From Participation in an Industry Sponsored Clinical Trial. The Guidelines are voluntary and are adapted from those of the Association of the British Pharmaceutical Industry.
  • RMI Code of Practice