Any information collected, generated, or discovered during a research study that is linked to the identity of a research participant.
These may be data that are :
- collected at the beginning of a study to determine if a person meets inclusion and exclusion criteria for the research
- generated about a participant during the progress of the research (raw data)
- discovered during the research that are beyond the aims of the research but have potential health or reproductive importance (often called “incidental findings”)
- identified, collated, or interpreted after analysis of the collected data and/or results has been completed (analyzable clinical trial data)
