Data filters allow for rapid display of specific data fields, data states, and subject populations; and also facilitates query lifecycle and review progress.
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Epoch, Cohort, and Subjects
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The data display can be quickly narrowed to specific subject populations by leveraging Epoch, Cohort, and Subject filters; where Epoch defines the stage of the study and Cohort defines a group of subjects within that stage.
Study Events
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Filtering by Study Event displays data fields collected on a specific trial day. For example: Day 1, Day 2, Day 3, etc.
Forms
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Filtering by Form displays data fields collected as part of a given data collection ‘page’ or ‘screen’. For example: Demographic, Dosing, or PK data.
Status
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Status filtering facilitates visualization of data in various states (i.e. complete, incomplete, out of range, etc) and is especially useful during data cleaning efforts.
Item Group Data
Complete - Returns item groups for which all mandatory items have been completed
Incomplete - Returns item groups which contain unanswered mandatory items for which the collecting user didn't have access to collect, usually due to role restrictions. A great example of this state would be a vitals signs form which has had parameters collected but is awaiting PI assessment of normality and/or significance
Nonconformant - Returns item groups with contain at least one nonconformant item. Nonconformant items are a result of one of the following scenarios:
Contradiction of a hard edit check or range check
Contradition of a soft edit check or range check before a user adds an annotation to the contradictory item
Leaving a mandatory field unanswered when a user has access to collect that field (i.e. role restrictions are satisfied)
Unsaved - Returns item groups for which no data has been collected
Canceled - Returns item groups which have been canceled
Not Canceled - Returns item groups which have not been canceled
Timing Deviation - Returns timed item groups which have been collected outside of the acceptable pre/post timing deviation window
Form Data
Canceled - Returns forms which have been canceled
Not Canceled - Returns forms which have not been canceled
Repeated - Returns forms which have been repeated by leveraging the Form Actions > Add Repeat function
Timed and Missed - Returns unsaved timed forms for which the scheduled time of collection is in now in the past
Misc
Out of Range - Returns item groups with contain at least one Out of Range item.
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Queries
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Out of Range items are a result of one of the following scenarios:
Contradiction of a hard edit check or range check
Contradiction of a soft edit check or range check
Subject Locked - Returns forms for only locked subjects
Data Value Changed* - returns item groups with items that had been edited after the initial value entry
*The Data Value Changed filter is available in ClinSpark version 23.3 and higher.
Queries
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Queries can be filtered based on their status as well as based on query issuer. This allows for rapid targeting of specific queries in various states. Note that query filtering is also supported by way of a query dashboard component within the Dashboard module.
Reviews
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Review progress can be tracked by filtering against review status as well as by reviewer. This allows for rapid targeting of specific data review states by various roles/departments.
Risk Based Approach
For data monitoring and review workflows, sponsors may want to know that all reviews are completed in order to trigger database locking. In some instances, study monitors may not review all forms, but apply a risk-based approach.
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