Scope
Data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources
What is RWD?
QA reviewers use this principle, meaning data must be Attributable, Legible, Contemporaneous, Original, and Accurate.
What is ALCOA?
The clinical evidence regarding the usage and potential benefits or risks of a medical product or procedure derived from analysis of real-world data (RWD).
What is RWE?
This facilitates the reconstruction of the history of such actions relating
What is an audit trail?
Process or algorithm that creates a random string of characters
What is tokenization?
In the U.S., this protects patient privacy and governs how data can be shared
What is HIPPA?
The process of preparing data for analysis, including data linkage, cleaning, transformation, standardization, and selection.
What is data curation?
The key question auditors ask to decide if a real-world study must follow GCP
What is "will the results be used for regulatory purpose?"