New to Research? – Don’t reinvent the wheel!
Clinical trials can be complicated and nuanced. The more you know, the more you realise there is to know. Fortunately, there is a lot of information freely available online and those who are new to the industry should take full advantage of these resources.
Click on the embedded links within this article to access the resources.
The basic principles and standards:
The internationally accepted standards for interventional clinical trials are the ICH GCP E6 (R2) guidelines.
NZACRes has links to free GCP training on our website.
In New Zealand, the National Ethics Standards for Health and Disability Research and Quality Improvement must also be applied to all research. These National Ethical Standards are provided by the National Ethics Advisory Committee (NEAC). The standards will provide guidance on the minimum requirements for research in New Zealand, such as essential document storage requirements.
The Guideline on the Regulation of Therapeutic Products in New Zealand, Part 11, is provided by MedSafe and describes the requirements for clinical trials involving new medicines.
Design and documentation:
The ICH GCP E6 guideline provides a list of essential documents that are required for an interventional trial.
Every trial needs a protocol. TransCelerate has established a Clinical Content & Reuse Initiative, within which they have developed a Common Protocol Template (CPT). They have also built Libraries of common subject protocols, such as for prostate cancer, diabetes etc. Additionally, the initiative provides other information and tools to assist with the implementation of a trial.
Almost all trials require a Patient Information and Consent Form (PISCF). The Health and Disability Ethics Committee (HDEC) website provides template PISCF documents. Although the wording does not need to be maintained exactly as written, it is highly recommended that any text changes are comparable in intent.
Prior to submitting a trial for review by the HDEC, scientific peer review is required. The HDEC provides guidance and a template for the review. If a trial is submitted for MedSafe approval, additional scientific review will not be required.
Submitting an Ethics Application:
Ethics submissions to the HDEC are done online.
When submitting an application, it is important to provide a current research Curriculum Vitae for the lead investigator. A research CV should be dated within 1 year and should also detail relevant research experience. TransCelerate provides a template CV and guidance.
NZACRes provides contract and indemnity templates for use in New Zealand.
We wish you every success in your research.