Prs serial registration#
Prs serial trial#

Expanded Access includes all expanded access types under section 561 of the Federal Food, Drug, and Cosmetic Act: (1) for individual patients, including emergency use (2) for intermediate-size patient populations and (3) under a treatment IND or treatment protocol.

Patient registries may be single purpose or on-going data collection programs that address one or more questions.Īn investigational drug product (including biological product) available through expanded access for patients who do not qualify for enrollment in a clinical trial. Note: The Agency for Healthcare Research and Quality (AHRQ) defines a Patient Registry as including an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, healthcare services, and/or procedures) and that serves a predetermined scientific, clinical, or policy purpose.

Prs serial registration#

This type of study should only be registered once in the Protocol Registration and Results System (PRS), by the sponsor responsible for the primary data collection and analysis. Patient Registry: An observational study that is also considered to be a Patient Registry.

This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. Studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health related outcomes.

Prs serial trial#

Required if Study Start Date is on or after January 18, 2017ĭefinition: If a Secondary ID Type of 'Other Grant/Funding Number,' 'Registry Identifier,' or 'Other Identifier' is selected, provide the name of the funding organization, clinical trial registry, or organization that issued the identifier.ĭefinition: The nature of the investigation or investigational use for which clinical study information is being submitted. The term 'participant' is used to refer to human subjects. Note: The term 'clinical study' is used to refer to both interventional and observational studies. For more information about various requirements and definitions of regulatory terms under 42 CFR Part 11, see Support Materials. The responsible party must ensure that the information provided complies with any applicable laws, regulations, or policies. These definitions are mostly adapted fromĭata element entries are annotated with symbols to indicate generally what information is required to be submitted (and under which circumstances). This document describes the definitions for protocol registration data elements submitted to for interventional studies (clinical trials) and observational studies. Protocol Registration Data Element Definitionsįor Interventional and Observational Studies