Intellectual property management (IP) in CTAs can be a complex issue. In general, the institution will contribute to intellectual property to ensure that it is not transferred to the sponsor and that it can freely sublicensing (called background IP). A sponsor probably needs full licensing rights for these background IPs to market and sell the developed product or processes, and in most cases, the sponsor will insist on owning the intellectual property created during or resulting clinical trial (so-called leading IP). The group worked closely with the Health Information and Quality Authority and other stakeholders to understand the perspectives of industrial auditors and hospitals with respect to the Specific Location Assessment (SSA) and the agreement with the Clinical Trial Agreement (CTA). To this end, the group has developed the following models for use in Ireland: 1. Site Specific Assessment Checklist – A checklist for assistance documentation, in order to determine the documentation that must be verified for local authorization before the local hospital completes a multi-axis clinical trial that has been approved by the ethics committee by another accredited ethics committee. 2. A business sponsorship model in Ireland (adapted to the presentation of ABPI in the United Kingdom) that reviewed and approved a legal and clinical compensation scheme. Launched in February 2011, the Model Industry Collaborative Research Agreement (MICRA) aims to support cooperation in clinical research involving the pharmaceutical and biotechnology industries, universities and NHS organisations in the UK. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the 2011 country versions. The accompanying guidelines provide more general information, an overview of changes from the 2011 versions, and additional information on how models should be used and under what circumstances. Molecular Medicine Ireland is pleased to announce the publication of streamlined models to facilitate the commissioning and approval of clinical trial trials of test drugs in the Republic of Ireland.
The NHS and HSC NSCs should be established through a subcontracting agreement with participating NHS and HSC organizations.