This type of agreement is used for the release of a test drug (PMI) by a qualified person (QP) before use. The agreement ensures compliance with current EU clinical trial guidelines (Article 51 of Directive 2001/83/EC, Article 55 of directive 2001/82/EC) / UK Medicines for Human Use Legislation. This type of agreement is used to facilitate the commissioning of certain professional services by a third party by the college. Under these agreements, it is not a question of conducting research or innovative work, but only of analyzing, processing, manufacturing or providing specialized knowledge. All results will be at the university without a right of use being granted to the counsellor. These agreements are not likely to conclude an agreement or cooperation in research. This type of agreement is used for clinical trials at sites outside Imperial College and, in the absence of a formal cross-sectional agreement with the NHS authority, it is also used for clinical studies within the College`s associated NHS Trusts (Royal Brompton and Harefield, Chelsea and Westminster, North West London Hospitals, Imperial College Healthcare NHS Trust). If the college is sponsoring a multi-center study, it must enter into an agreement with each participating site (normally a university or NHS Trust). The agreement ensures that the site is committed to complying with the laws, regulations and codes of conduct applicable to the study (“Research Governance Framework for Health and Social Care”/UK Medicines for Human Use (Clinical Trials) Regulations). It contains provisions such as security reports, insurance/commitments, medical confidentiality, intellectual property, publications, financing, if any, etc. A sponsorship agreement is a simplified version of a single participatory site agreement for clinical trials, which is suitable for less complex non-unthinkable studies (study without test drug). The agreement is signed between the promoter and the participating website and confirms the college`s overall responsibility as a legal sponsor and describes the specific responsibilities of the site in relation to the study (i.e. the transfer or recruitment of patients to the college).
This agreement requires a research partner to have a specific set of work in the context of a research project (or a number of research projects) implemented by the college and usually involves payments to the partner. The agreement is often developed following a major grant or other research funding agreement and includes discreet and specific work to be done by a partner organization. The college remains responsible for the main distinction, but will often pass on all relevant conditions to the research partner and, as such, these are reflected in the partial agreement.