Filtering Data

Data filters allow for rapid display of specific data fields, data states, and subject populations; and also facilitates query lifecycle and review progress.

Epoch, Cohort, and Subjects

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

Filtering by Study Event displays data fields collected on a specific trial day. For example: Day 1, Day 2, Day 3, etc.

Forms

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

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.  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

  Open

  

Queries

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

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.

More information about using filters to accomplish reviews in this scenario can be found here:

• Monitoring & Review for Data Locking