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.
An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation.