Clinical Trials
Good Clinical Research Practice
Are you thinking of conducting a clinical trial or have you been asked to participate in a clinical trial by a pharmaceutical company?
If the answer to either of these questions is yes, and knowing it is unethical to enlist the cooperation of patients in studies which are not adequately designed and conducted, you will be interested in the Interim Good Clinical Research Practice Guideline.
The guideline aims to make those involved in the design, performance and analysis of clinical studies aware of the minimum requirements for high quality research. The need to evaluate the risks and benefits of any investigational product, device or procedure prior to commencing a clinical study is discussed. Additionally, the guideline outlines the requirements for obtaining informed consent, quality control, audit, data recording, analysis, interpretation of the results and reporting of adverse events for studies conducted in New Zealand.
The principles contained in the guideline are pertinent to all phases and types of clinical investigation in human participants. Its spirit, therefore, should permeate all clinical research.
Pharmaceutical companies conducting clinical research have to comply with the principles contained in the guideline. It is essential that doctors are familiar with Good Clinical Research Practice requirements and assess the proposed research for compliance prior to participation.
This guideline is based on the EU, UK, Nordic, Australian, WHO and Committee for Proprietary Medicinal Products (CPMP) guidelines and codes for Good Clinical Research Practice. The New Zealand guideline remains interim until the CPMP guideline, whilst finalised, is accepted as the de facto world standard.
New Zealand Regulatory Guidelines for Medicines
Volume 3: Interim Good Clinical Research
Practice Guideline (Microsoft Word document 3,452KB)
Amendments/Additions to Volume 3