A medicinal product may only be placed on the market in the European Economic Area when a marketing authorisation has been issued by the competent authority of a Member State (or EEA country) for its own territory (national authorisation) or when an authorisation has been granted in accordance with Regulation (EC) No 726/2004 for the entire Community (a Community authorisation).
|Marketing Authorisation Holder||
The entity that has been granted a Marketing Authorisation. Marketing Authorisation Holders must be established within the European Economic Area.
Model Clinical Investigation Agreement for medical devices, covers the running of the study, not design of prototype or design of protocol; standard template for the UK (use is not obligatory)
|Members of the Public||
INVOLVE uses this term to cover public (or public), patients and potential patients, people who use health and social care services, informal unpaid carers, parents/guardians, disabled people, members of the public who are potential recipients of health promotion programmes, public health programmes, and social service interventions, groups asking for research because they believe they have been exposed to potentially harmful substance or products (e.g. pesticides or asbestos) organisations that represent people who use services. Other organisations have different definitions of this term.
|Mental Capacity Act (2005)||
Provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. It makes it clear who can take decisions, in which situations, and how they should go about this.
A mentor is a person willing to share their experience, knowledge and wisdom to help, guide and support someone who is less experienced. Mentors act as friends, teachers and advisers. A person who is newly involved in research can ask for a mentor to help them adjust to their new role.
Combining data from multiple independent studies. May be undertaken in evidence syntheses.
The term methodology describes how research is done, so it will cover how information is collected and analysed as well as why a particular method has been chosen.
|Minor Injuries Unit||
A hospital department in the UK largely staffed by emergency nurse practitioners (ENPs) working autonomously looking after minor injuries such as lacerations and fractures, and have access to X-ray facilities.
The person designated by the sponsor to perform site visits and conduct the monitoring process e.g. check whether there are any deviations from the protocol and that all source data was transferred into the Case Report Forms correctly
Monitoring research involves keeping up to date with the progress of a research project. This will include ensuring that the researchers are carrying out their research according to their research proposal or protocol, that the research is keeping to time and budget and that the research is being conducted ethically.
Care of conditions related to body muscles, bones and joint mobility.