Clinical research

Clinical trial participation longitudinal 

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: 17.01
Usage in other datasets: SMALGMD
Value ID Description
Currently

This is currently the case

Previously

This has previously been the case, but is not currently

Never

This has never been the case, neither previously nor currently

Sometime

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

Record

Clinical trial          

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 must be provided whenever the information is available.

If known, Clinical trial NCT number should be provided; in this case, Clinical trial name and Clinical trial drug may be left unspecified.

Clinical trial NCT number

NCT number (ClinicalTrials.gov identifier) of the clinical trial, including the prefix "NCT", for example "NCT00004451".

Item type: restricted text
Related items in previous version: 17.02
Clinical trial name

Full name of the clinical trial that the individual is currently participating or has previously participated in.

Item type: free text
Related items in previous version: 17.03
Usage in other datasets: SMALGMD
Clinical trial drug

Full name of the drug that the clinical trial named in Clinical trial name was evaluating.

Item type: free text
Related items in previous version: 17.03
Usage in other datasets: SMALGMD
Other registry participation CR  PR  datestamped 

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)

Item type: yes/no
Related items in previous version: 1.07, 17.04
Usage in other datasets: SMA
Other registry CR  PR  datestamped 

Comma-separated list of the full name of each registry or natural history study in which the individual is currently participating.

For observational studies listed on ClinicalTrials.gov, the NCT number (ClinicalTrials.gov identifier) may be provided instead of the name.

Item type: free text
Related items in previous version: 1.08, 17.05, 17.06
Usage in other datasets: SMA