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Executive sponsor (sometimes called project sponsor or senior responsible owner) is a role in project management, usually the senior member of the project board and often the chair. The project sponsor will be a senior executive in a corporation (often at or just below board level) who is responsible to the business for the success of the project.
Guidance for Industry. [23] This guidance provides sponsors and review staff with the Agency’s thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drugs, including drugs subject to licensing as biological products.
The Combined Construction and Operating License (Regulatory Guide 1.206, COL) replaced the previous Draft Regulatory Guide 1145 as the licensing process for new nuclear power plants in the United States. It is a part of a newer "streamlined" process that encourages standard plant designs, and prevents delays in operation that contributed to the ...
the organisation will meet its sponsorship duties. These criteria are to ensure that those working or studying in the UK do so legally. If the potential sponsor is awarded a sponsor licence, they will be given a sponsor rating - this will be an 'A rating' or a 'B rating', and will be listed on the register.
These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements." [1] Historically, TMFs have been paper-based content sets stored in physical file cabinets, central file rooms, or shelved in binders. The size and complexity ...
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The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
Joseph and One-Six flew to Afghanistan in March 2008 from Camp Lejeune, N.C., and on May 1, assaulted into a suspected Taliban stronghold in a town called Garmsir. There was little resistance. The Marines came home that October and 14 months later, in December 2009, they went again. This time was different.