Clinical Study Agreements

CTA models commonly used in the UK are compliant with the current regulatory system. Practitioners should therefore ensure that proposals are updated with the new legislation when they come into force. However, the question is how Brexit will have an impact on the legal framework. The issues raised by Brexit go beyond the scope of this article, but there are certainly real concerns among health professionals that, whatever the time and mechanism for the UK`s exit from the EU, if the UK does not adapt to the EU post-Brexit regime, it will be a much less attractive prospect for clinical trials and scientific progress. As a public non-profit educational institution, the university is subject to certain policies and rules on what it can and cannot accept in a clinical trail contract. These actions are aimed at protecting the well-being of those involved in research activities, promoting the university`s fundamental mission in teaching, research and public service, and minimizing the various forms of responsibility associated with human research. Sponsored Projects (SP) is responsible for the verification, negotiation and legal implementation of agreements from external funding sources. Solving many contractual problems requires coordination between the external source of funding, the auditor and the PS; the participation of each party is essential to the success of a contractual agreement with conditions acceptable to both parties. This type of agreement can be initiated by a sponsor or reviewer. A clinical trial agreement, initiated by a sponsor, is required if the drug or device under review has financial support. Let`s look at the key issues that may arise and should be addressed ethically in all CTAs. The issue of publication must be carefully considered. Blumenthal et al.,10 reported that 19.8% of a random sample of university scientists from major research institutes delayed their publication by more than six months due to the intervention of sponsors.

In a classic example, a group of researchers completed a study sponsored by Boots Pharmaceuticals Inc.