Study Agreement

Studies conducted by auditors are designed by academics and are usually sponsored by their employer. These studies are funded by grants from charities, research councils, government agencies, etc., or with the help of pharmaceutical companies. When a pharmaceutical company provides funding (and, in some cases, free medicines), an agreement must be reached between the college and the company to ensure that each party agrees to comply with the laws, regulations and codes of conduct applicable to the conduct of the study. The agreement contains provisions concerning the supply of medicines, financing, declaration of security, insurance/debts, publications, intellectual property, etc. A Material Transfer Agreement (MTA) is a contract that regulates the transfer of research material between two organizations when the recipient intends to use it for its own research purposes. It defines the rights of the parties with regard to the use of the material, confidentiality, publication and intellectual property. From time to time, transmission software may contain. Such agreements should not include payment for equipment, with the exception of reimbursement of transport costs. This type of agreement is used for the release of an investigational drug (PMI) by a qualified person (PQ) before use. The agreement ensures that the sponsor complies with the current EU Clinical Trials Directives (Article 51 of Directive 2001/83/EC, Article 55 of Directive 2001/82/EC) / UK legislation on medicinal products for human use.

This type of agreement is concluded if the college wishes to enter into a contract with a pharmaceutical company for the manufacture of a drug in accordance with the college`s specifications and/or the materials provided by the college. Manufacturing agreements are required both for the manufacture of investigational medicinal products and for the repackaging/dose modification of existing medicinal products for new indications. These are complex agreements that need to be carefully vetted to include compliance with legislation (GMP facilities/standards, compliance with UK/EU/FDA regulations, manufacturing authorisation requirements for investigational drugs, etc.), warranties and indemnifications. The college`s insurance coverage must be taken into account in the context of this type of agreement as well as the subsequent use of the product in clinical trials. This type of agreement is used when external parties wish to provide “benefits in kind” for studies conducted by verifiers, such as the supply of medicines or medical devices. If the provisions relating to such contributions are not part of a main funding agreement, a delegation agreement should be concluded between the supplier and the college in order to describe the responsibilities of each of the parties with regard to the study and to ensure compliance with the legal framework (guarantees/commitments, delivery volumes, security statement, confidentiality, etc.). This type of agreement is used to facilitate the order of certain professional services by a third party by the university. Within the framework of these agreements, it is not a question of research or new work, but only of analysis, processing, production or provision of expertise. All results are the property of the university without any right of use being granted to the consultant.

These agreements are not suitable for a research sub-agreement or cooperation. A cooperation agreement is required for work involving at least one other research partner in a project. This agreement entrusts a research partner with a specific set of work as part of a research project (or a number of research projects) owned by the university and normally involves payments to the partner. The agreement is often established as a result of a main grant or other research funding agreement and includes discrete and specific work carried out by a partner organisation. . . .