Standardised Clinical Trial Research Agreement
Background
The New Zealand Association of Clinical Research (NZACRes) has developed a standardised Clinical Trial Research Agreement (sCTRA) based on the Medicines Australia template that has successfully been used in Australia. The sCTRA Working Group has consulted widely with the New Zealand clinical research industry in New Zealand to produce the first New Zealand version of the standardised Clinical Trial Research Agreement.
This agreement has undergone an independent legal review and the sCTRA Working Group intends to conduct a six month post-release review (April 2012) to address any feedback received after publication.
Objectives
to develop a standardised Clinical Trial Research Agreement for use in contract clinical trials in New Zealand, consistent with international practice;
to save time, money and manpower in order to facilitate the approval process;
to have a streamlined contract negotiation process in order to reduce clinical trial start-up times;
to ensure that New Zealand remains an attractive location to conduct clinical research.
Advantages
Single legal review required for main body of the contract when used for the first time.
Contracting process is de-risked for all contracting parties by having consistent contract terms with all clinical trial Sponsors.
Only Schedule 2 and Schedule 7 will need to be negotiated and reviewed, eliminating the need for a full review of contract, creating a streamlined contract negotiation process.
Download
Click here to download a copy of the sCTRA Guidance Document.
Working Group Members:
Claire Arandjus, ICON Clinical Research (NZ) Ltd
Pat Barnes, Roche Products (NZ) Ltd
Olga Bucan, GLCC Research Organisation Ltd
Jan Campbell, Roche Products (NZ) Ltd
Michael Gibson, Trident Clinical Research
Marina Dzhelali, Capital & Coast DHB
Catherine Green, MSD
Karin Gruber, Covance Pty Ltd
Aline Hauter, Sanofi-Aventis
Amanda Mark, Waitemata DHB
Lorraine Neave, Waitemata DHB
Stuart Ryan, Centre for Clinical Research and effective practice (CCRep)
Tracy Schuurman, GLCC Research Organisation Ltd (sCTRA Working Group Coordinator)
Andrew Skinner, Fisher & Paykel Healthcare
Susan Watson, Capital & Coast DHB
