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. 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). The purpose of a research contract is to define the roles and responsibilities of the parties involved in a research project, i.e. the college, academics, researchers, students and the funding centre. The contract is concluded: This type of agreement is executed if the college wishes to enter into a contract with a pharmaceutical company for the manufacture of a drug in accordance with the specifications of the college and/or with the equipment provided by the college. Manufacturing agreements are needed for both the manufacture of experimental drugs and the reconditioning/modification of the dose of existing drugs for new indications. These are complex agreements that need to be scrutinized, with regard to compliance with legislation (GMP/standards, compliance with UK/EU/FDA legislation, manufacturing authorisation for the investigative product (MA-IMP), guarantees and compensation. Coverage of higher education institutions must be taken into account in this type of agreement and the subsequent use of the product in clinical trials.
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.