Neverwith suitable user-friendly wording. See the introduction for more information and alternative ways to collect this item.
Specifies whether the individual is currently participating or has previously participated in an interventional clinical trial. In this context, ‘participated’ means the individual has passed the screening period and has been either randomised (in randomised trial) or dosed (in non-randomised trial). If an individual fails the screening period, or is not randomised/dosed for some other reason (for example consent withdrawal, family relocation), this is not classed as participation.
|Item type:||single selection|
|Related items in previous version:||13.00|
|Usage in other datasets:||DMDLGMD|
This is currently the case
This has previously been the case, but is not currently
This has never been the case, neither previously nor currently
This has been the case at some time, but it is unknown whether it is currently the case
|Not currently|| |
This is currently not the case, but it is unknown whether it has previously been the case
For each clinical trial the individual is currently participating or has previously participated in (as defined in the item
Clinical trial participation), a record instance should be provided.
Specifies whether the individual is currently part of another registry and/or natural history study, in addition to this registry.
A patient registry can be defined as “an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes.” (Gliklich et al. 2014)
Natural history studies can be defined as “epidemiological studies that focus on describing the frequency, features, and evolution of a disease by collecting real-world data from groups of patients suffering from this disease.” (Bevan et al. 2019)
|Related items in previous version:||13.10|
|Usage in other datasets:||DMD|