For non-commercial trials conducted in England, the HRA statement of activities can be used as an agreement between the sponsor and a participating website and can be found on the HRA website. Despite their intention, requests to amend MCTs have increased significantly in recent years, due in part to the outdated data protection provisions contained in the models that have not fully taken into account the application of the General Data Protection Regulation (GDPR) and the UK Data Protection Act 2018 (DPA). If you are applying for HRA authorization for your study, you may also find it useful to refer to the standard document and HRA evaluation criteria, as this includes reflections on the use of model agreements. You can find the document on our HRA special approval page. If a model based on the agreement model contains changes, the sponsor will explain the reasons. The MCTA is concluded by the sponsor and the institution (i.e. the organization of the participants), while the CRO-mCTA will be used if, in addition to these two parties, the sponsor enters into contracts with a CRO responsible for the aspects of field trial management. The role assigned to the parties continues to reflect the position of HRA and the business community, which considers the sponsor to be responsible for personal data and the organization of the participants and the CRO as a subcontractor acting on behalf of the sponsor for the purposes of the clinical trial (clauses 6.2.1 mCTA and CRO-mCTA). With regard to health and social protection research, the new regulation is not very different from the previous law and the health research authority will not complement existing effective safeguards. In particular, the approval of the Research Ethics Committee (REC) and the legal gateway for the handling of confidential patient information on the advice of the Privacy Advisory Group (CAG) are continuing, as are other common law rules.
A summary of key changes to overall data processing (not just research) is available from the Information Governance Alliance. The Triapartit agreement is intended in the event that the sponsor`s management of a commercial clinical trial is outsourced to a contract research organization. CRO mCIA is supported by the UK Health Services, the National Institute for Health Research, the Association of British Healthcare Industries, the NHS Confederation, the Medical Schools Council, the UK Clinical Research Collaboration, the NHS Research Forum and the Institute for Clinical Research. Updated versions of the UK Clinical Trial Agreement (mCTA) and the Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA) have been published. Given the growing importance of safe but rapid clinical trials in the coronavirus era, this contribution describes the key changes introduced from a data protection perspective and what they mean for contracting parties. The Association of the British Pharmaceutical Industry (ABPI), Health and Care Research Wales (HCRW), Health and Social Care Northern Ireland (HSC NI), the Health Research Authority (HRA), England) and NHS Research Scotland (NRS) have adopted 2020 versions of the Commercial Model Clinical Trial Agreement (mCTA) and the Clinical Research Organisation model Clinical Trial Agreement (CRO-mCTA), first published in 2003 and 2007 respectively. These model models have been designed to streamline the licensing process for commercial studies and should therefore be used without modification by proponents conducting clinical trials of patients with NHS/HSC in hospitals across the UK. MCTAs and CRO-mCTAas have generally been updated to reflect the new data protection rules (RGPD and DPA) with provisions for coded data sharing, security and data breaches. The Clinical Trial Agreement for biopharmaceutical industry sponsored research in primary care (Primary Care mCTA) has been developed and approved by the Association of the British Pharmaceutical Industry, the BioIndustry Association, a number of highly active general practitioners, the British Medical Association, the Protection Medical Society and UK health authorities.