Prospective Observational Study definition

Prospective Observational Study means a study in which the actual (i.e., real world) experiences of the groups being compared are prospectively observed, which study yields information on “real world” practices and outcomes where there is no artificial control or assignment of patients to treatment options.
View Source

Examples of Prospective Observational Study in a sentence

  • The PI will acknowledge the source of the Data Set by including language similar to the following either in the acknowledgement or in the text of the manuscript: “The Cortisol Quantification Investigation (CQI): Prospective, Observational Study Comparing Free versus Total Serum Cortisol in PICU Patients Trial Data Set obtained from UTAH, and does not necessarily reflect the opinions or views of the CQI investigators or the NICHD.

  • The Institution and the Investigator will conduct the study entitled “A Prospective, Observational Study to Assess the Real-World Usage and Outcomes of HyQvia in Patients with Multiple Myeloma (MM) diagnosed with Secondary Immunodeficiency (SID) ShortTitle: HyQvia NIS in MM patients with SID” (the “Study”) at Institution in accordance with the protocol, incorporated herein by reference (the “Protocol”).

Related to Prospective Observational Study

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S).

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.