Using the central limit theorem to justify approximating the sample mean with a normal distribution yields an approximate 95% confidence interval of the form. If we wish to have a confidence interval that is W units in width, we would solve. for n, yielding the sample size n = 16 Ï2/W2.
Sponsor and sponsor-investigator are defined at 21 CFR 312.3(a): Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.
The legal definition of a sponsor is contained in Regulation 3 of the Medicines (Database of Medical Devices) Regulations 2003 and states; 1  sponsor, in relation to a medical device 2  -. means 3  -. a person in New Zealand who exports, or arranges the exportation of, the device from New Zealand: