Research Agreement Of

December 16, 2020 – 6:47 am

A cooperation agreement is required for work involving at least one other research partner in a project. Investigator-led studies are designed by academics and generally sponsored by their employer. These trials are funded by grants from charities, research councils, government authorities, etc. or with the support of pharmaceutical companies. When a pharmaceutical company provides funding (and, in some cases, free drugs), an agreement must be reached between the college and the company to ensure that each party is committed to complying with the laws, regulations and codes of conduct applicable to the completion of the study. The agreement contains provisions relating to the supply of drugs, financing, security reports, insurance/commitments, publications, intellectual property, etc. 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). It is an agreement to regulate how confidential information, including intellectual property, can be disclosed from one party to another. The agreement sets out the terms of publication and whether information is returned or destroyed at the supplier`s request. Confidential information includes any information, results or any information held by a person and which the owner wishes to keep secret. Disclosure of confidential information requires the signing of a confidentiality agreement before any discussion.

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