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.
If the Responsible Party, by Official Title is either Principal Investigator or Sponsor-Investigator, the following is required: 1  Investigator Name: Name of the investigator, including first and last name. 2  Investigator Official Title: The official title of the investigator at the primary organizational affiliation.