Indicator “Uncertain time-date values”
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Definition
Observed time-date values are uncertain or improbable because they are outside the expected ranges.
Explanation
The identification of uncertain time-date values is methodologically identical to inadmissible time-date values. Yet, the meaning is different. The latter identifies inadmissible values and a certain data quality issue. The former identifies uncertain data values and a potential data quality problem. That is the case because a value may for example be improbable but plausible.
Identified uncertain values merit some further inspection to reach a decision on whether a problem exists.
In other concepts the applied range limits are also described as “soft limits”. In eCRF commonly such values receive a warning at data entry.
Example
In a health survey, clinical examination time and duration are subject to a check. For the start of an examination, a limit has been set to 11 am, as according to the protocol, all blood samples should be taken before 10 am. Applying this criterion reveals that several time stamps are later than 11 am. A consultation with the examiners reveals that participants arrived late in these cases, so the times after 11 am are still correct.
Guidance
Any violation triggers primarily processes to decide whether an uncertain time-date value is correct or not. Should no such check be possible an elevated count of uncertain numerical values can be interpreted as sign of a potentially lower data quality.
Interpretation
The higher the number or percentage of inadmissible time-date values the higher the probability of a lower data quality.
