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.
FDA Requirements. A sponsor-investigator assumes all sponsor responsibilities required by the FDA of the sponsor and. the investigator, including those related to record keeping and prompt reporting of safety reports to. the FDA. The responsibilities include: â¢ Selection of research staff qualified by training and experience.