This clinical trial will be conducted at multiple sites under existing NIAID-sponsored contracts and grants. NIAID will act as the sponsor of the Investigational New Drug (IND) application. NIAID contractors, fellows, research networks, clinical research sites or their investigators are not parties to this Agreement. Nationally approved model site agreements help speed up the contracting process for industry-sponsored studies conducted in the NHS by eliminating the need for site reviews and local legal arrangements. This allows trials to start earlier, improving the speed of industry-sponsored clinical trials and giving NHS patients faster access to innovative treatments. The set of model site agreements is supported by guidelines that set out the objectives and provide details on how the agreement should be used in the development of clinical research contracts sponsored by pharmaceutical, biopharmaceutical or medical device companies. The triapartite agreement is intended for the case where the management of a commercial contractual clinical investigation is outsourced from the sponsor to a contract research organisation. CRO mCIA is supported by the UK Ministries of Health, 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 R&D Forum and the Institute for Clinical Research. The Model Clinical Trials Agreement for Primary Care (mCTA) sponsored by the biopharmaceutical industry has been developed and approved by the UK Pharmaceutical Industry Association, the BioIndustry Association, a number of GPs highly active in research, the British Medical Association, the Medical Protection Society and the UK Ministries of Health. The Health Research Authority (HRA) supports the use of model agreements.
If an agreement is expected to exist between the proponent and the site (including all commercially sponsored studies), it is strongly recommended that an unchanged model agreement be used. These provisions should be used as set out in the attached guidelines. Using the unchanged agreement template simplifies and speeds up the study setup process. The uk Clinical Research Collaborations (UKCRC) model agreements have been negotiated with English law and governance agreements at their core, and amended versions are available for use in the legal systems and administrative arrangements of Scotland, Wales and Northern Ireland. The use of a modified model agreement or an agreement that is not based on a model model is possible, but the proponent should be aware of the difficulties that can often arise, such as . B longer negotiation periods and the risk that the study cannot be conducted if certain conditions cannot be agreed with the participating organisations. The adoption of this more robust documentation is particularly welcome in the current climate and is an important step forward in addressing the need to streamline COVID-19 clinical trials. This need is also reflected in the expedited COVID-19 testing approval process, which is reduced from about 80 days to just 24-72 hours.
Like the 2018 models, the ERS expects the new mCTA and CRO-mCTA to be used unchanged. The mICRA was developed by a working group led by NIHR`s Office of Clinical Research Infrastructure (NOCRI) and the Medical Research Council. Representatives from industry, academia, the NHS and the Intellectual Property Office worked with legal advice to develop a model agreement that could support all collaborative research scenarios. The organisations involved in the working group agreed on a favourable statement promoting its use in order to streamline the contractual process for collaborative research. The NHS and HSC ICPs should be established through a subcontracting agreement with the participating NHS and the HSC organisation supported by the PIC. Appropriate arrangements for data processing should be made using the relevant model agreement: where a model based on the model agreement is submitted but contains amendments, the sponsor must explain the reasons. The most fundamental change is that the revised models apply to health services in England, Northern Ireland, Scotland and Wales, replacing the country-specific 2011 versions. Therefore, a single model contract for commercial clinical trials across the UK will be possible, eliminating unnecessary administration to conduct the same study across the UK.
ABPI commented that “the new mCTA enjoys broad support from life sciences leaders within government across the UK for the potential to accelerate innovative research and development.” This model agreement for clinical trials was developed as part of a collaboration between vereniging Samenwerkende Topklinische opleidingsZiekenhuizen (STZ), Nefarma, Stichting Het Nederlands Kanker Instituut – Antoni van Leeuwenhoek Ziekenhuis (NKI/AvL) and ACRON to facilitate the conduct of clinical trials in the Netherlands. The termination and publication clauses are consistent with the CCMO`s Directive on Clinical Trial Agreements. For studies approved by the RHS, the RHS Initial Assessment Letter (and the RHS Approval Letter) specify the appropriate agreement for each site type in a study. The document may be the Statement of Activities and Schedule of Events, an unchanged agreement template (e.B. mCTA) or another document provided by the proponent. These model agreements apply to health services in England, Northern Ireland, Scotland and Wales; they replace the country-specific versions of 2011. The accompanying guidance notes provide further background information, an overview of changes from the 2011 versions, and additional information on how and under what circumstances the models should be used. Before a clinical trial can begin, it is important to reach an agreement between the parties establishing the respective responsibilities and obligations.
In the UK, where the clinical trial is being conducted in the NHS, various model agreements, including mCTAs, have been developed as a standard contract accepted by both the pharmaceutical industry and NHS bodies. The aim is to simplify and therefore speed up the launch of studies with NHS patients in NHS hospitals. The models are intended for unchanged use, with the exception of information specific to the study. In practice, mCTAs are considered standard models, and it is difficult for the industry to propose changes without significantly increasing costs. If you are applying for RHS approval for your study, it may also be useful to refer to the RHS evaluation criteria and standards document, as this includes considerations for the use of model agreements. You can find the document on our page dedicated to the approval of the RHS. For example, standard contractual clauses (SCCs) required in clinical trials in the absence of other measures where it is relatively common for sponsors to be based outside the EEA and the United Kingdom have not been included in the revised mCTA and CRO-mCTA. There are several different models of agreements, and you should use the one that best suits your type of studies and sponsorship agreements. For more information, visit the IRAS website. Updated versions of the UK Clinical Trial Agreement (mCTA) model and the Clinical Trial Agreement (CRO-mCTA) model of the uk Research Organisation model have been published. Given the growing importance of safe but rapid clinical trials in the time of the coronavirus, this article describes the most important changes from a data protection perspective and their importance for contracting parties.
The Health Research Authority (HRA) in England and the health services of the decentralised administrations expect sponsors (and CROs) to use the February 2018 mCTA unchanged and compliant with the guidelines when contracting with NHS/HSC organisations to conduct industry-sponsored studies. Similarly, NHS/HSC organizations are expected to accept unchanged mCTAs without further consideration of the default template elements. Launched in February 2011, the Model Industry Collaborative Research Agreement (mICRA) aims to support clinical research collaborations between the pharmaceutical and biotechnology industries, universities and NHS organisations across the UK. 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) adopted versions of the Commercial Model Clinical Trial Agreement (mCTA) and the Clinical Research Organisation Model Clinical Trial Agreement (CRO-mCTA) in March 2020. which were first published in 2003 and 2007 respectively. These model agreements have been designed to streamline the approval process for commercial trials and should therefore be used without modification by sponsors conducting clinical trials on NHS/HSC patients in hospitals in the UK healthcare system. .