Medsafe Standards & Terminology
The Medsafe document ‘Guideline on the Regulation of Therapeutic Products in New Zealand. Part 11: Clinical Trials – regulatory approval and good clinical practice requirements’ provides the standards and terms that are used by Medsafe. https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf
The standards referenced are the Guideline for Good Clinical Practice E6(R2) (EMA/CHMP/ICH/135/1995). The CHMP guidelines are referenced instead of ICH GCP due to a historic memorandum of understanding between the UK, Australia and NZ. Essentially, the CHMP GCP guidelines are an exact copy of the ICH GCP guidelines, that have been ratified for use in Europe.
Some of the roles defined in the Medsafe Part 11 document differ from the internationally recognised ICH GCP definitions.
ICH GCP & HDEC
- ICH GCP E6 (R2) definitions.
- Sponsor is an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
- Co-ordinating Investigator – An investigator assigned the responsibility for the coordination of investigators at different centres participating in a multicentre trial.
- Investigator – A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.
- Sub-investigator – Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
- Part 11 ref: Guideline for Good Clinical Practice E6(R2) (EMA/CHMP/ICH/135/1995)
- In Part 11 the Applicant is the person in New Zealand who takes legal responsibility for the conduct of the trial in New Zealand and submits the application for approval of the trial to Medsafe.
- Once a trial is approved by the Director-General of Medicine in NZ, the applicant becomes the Sponsor . The sponsor assumes responsibility, including legal responsibility for the trial in NZ. The Sponsor must be based in NZ.
- Part 11: 5.2.2 The principal investigator is the person with overall responsibility for the conduct of the clinical trial in New Zealand. There is only one principal investigator for a trial, regardless of the number of trial sites involved.
- A lead investigator is the person responsible for the conduct of a trial at a particular trial site. For a multi-centre trial, there will be a lead investigator for each trial site.
- An investigator is an individual who is designated to conduct clinical trial procedures at a particular trial site.
Refer to Medsafe document for further guidance: https://www.medsafe.govt.nz/regulatory/Guideline/GRTPNZ/Part11.pdf
- The New Zealand Health & Disability Ethics Committee (HDEC) use the ICH GCP terminology.
- Medsafe and HDEC share the same online submissions portal ‘NZ Online Forms’ https://nz.ethicsform.org/signin.aspx
- The Online Forms User Manual provides guidance on this process. However, the Medsafe terms for Principal Investigator and Lead investigator are not used as per the Part 11 document in the Online Forms User Manal. https://nz.ethicsform.org/Help/Online%20Forms%20User%20Manual%201.1.pdf
Note, in the ‘Online Form User Manual’ :
- The Principal Investigator role is referred to as the Co-ordinating Investigator (CI)’.
- The Lead Investigator role is referred to as the ‘Lead Investigator / Principal Investigator’ or ‘Other Investigators’.