Summary Metrics and Listings that are Commonly Used to Track Study Progress
Here is a list of metrics displayed in the Dashboard:
- Site and Subject Enrollment Progress
- Records Entered, missed, and incomplete
- Query counts
- Adverse Events
- Protocol Deviations
- Study Exits
- Review/workflow progress
The Dashboard Report is available on both the web browser and mobile app. It will only allow access to data for site(s) of which you are a member.
Prerequisite: Access to the Dashboard Report
Once open, select at least one site to see the applicable metrics as shown below.
Web Browser: (numbers referenced in the descriptions below)
Descriptions of the numbers
1. Site and Subject Enrollment Progress
Planned Subjects and Sites
The total number of planned sites is defined in the study configuration.
The number of subjects planned can come from two different areas, depending on if the total planned subjects is a total across the entire study or there are individual goals set for each site.
If there is no value defined in the study configuration (study-wide goal), then the system uses the per-site goal defined in the site documents (only visible to the Administrative role). The planned number in that case depends on the sites being filtered in the Dashboard. If there is a value defined in the study configuration, the system will default to displaying that value as the total planned number across the whole study, regardless of which sites are being filtered in the dashboard.
Actual Subjects and Sites
The actual number of sites is based on the number of sites currently being filtered.
The actual subjects are dependent on the study configuration. By default, the system counts the number of registered subjects at the current filtered sites. However, if the study configuration has an enrollment variable defined, that is used instead. This way study builders can define how "enrolled" subjects get counted.
2. Study Progress
CRFs Entered - This displays the total number of CRFs entered, regardless of their statuses.
CRF Drafts - Applicable to studies that allow for saving forms as draft, this displays the total number of CRFs entered and saved in the draft mode. If you click this metric, a table is displayed below the Review Progress table. The table displays each CRF and allows you to view the Site, Subject, or CRF by clicking on the link and drilling into the subject record.
CRFs with Errors - CRFs that have errors or automatic queries along with error messages. This is the number of CRFs that contain at least one error. To see a list by Site of those CRFs, click the metric. A CRF Errors table will be displayed below the Review Progress table; from there you can drill into the form to obtain additional information if desired.
Missing CRFs - When visits are scheduled they are required within a subject-specific time range. If a given CRF is not completed within that date range it is considered “missing”. The number displayed in this column of the table is the total number of missing CRFs that are past the visit window. This number can be clicked to produce an exportable list at the bottom of the page. It can also be utilized to click directly into the missing CRFs to complete them.
Deviations - The Deviation form is defined in the Study Configuration application accessed from the Study menu. This metric represents the total number of Deviation forms that have been entered into the system.
Study Exits - This displays the number of subjects which have a withdrawal form entered (and saved). Since only one withdrawal form can be entered per subject, the number of withdrawal forms will show you how many participant withdrawal forms have been entered (and saved) in the study. The form serving as the withdrawal form is defined in the study configuration workflow under the study menu.
3. Query Summary
This section provides an overall view of the number of queries.
Total Queries - This metric is the total number of queries that exist, regardless of the query type or status. It can be tapped to expand a table of the full query list. This can also be accessed with more details in the Queries Report.
NOTE: The total number displayed will exclude queries that are not distributed to the viewer's role and queries that exist on fields blinded to the viewer's role.
Open Queries - This metric shows the current number of queries that are still open and await resolution.
Closed Queries - This metric shows the current number of queries that are closed. Combined with the open queries, this should equal the Total Queries.
4. Adverse Events
Total Adverse Events - This is the total number of Adverse Event forms that have been saved. If a specific variable is defined by the Study Configuration, it could mean the number of AEs is not necessarily equal to the number of forms entered.
Number of Subjects with at least 1 AE - Similar to the total AEs, but reducing the count down to only count one AE per subject. Also presented as % of Subjects with at least 1 AE
5. Review Progress
The Review Progress table shows the current number of records awaiting review or that have been reviewed at each review level. The type and number of review levels are defined by a study Administrator.
Tapping on any of the metrics will expand the list of corresponding records. You can then tap the date to drill into each record.
The Action Item Report normally serves as a better tool for conducting review actions. The Dashboard report is intended mainly for viewing progress.
Understanding the Numbers Shown in the Review Progress Table
Ideally, at the end of the study, all records would be counted in the completed column of the last review level. All other columns would read zero. In other words, as the review of records progresses, the count in the completed column will decrease as it's completed by the next level. However, when a value is clicked to produce a list of those records, the list may contain more than that number of records. The reason being is that all records which have ever had that status will be listed. Also note, if using the soft review functionality for the first review level, a record may be completed at level one but not necessarily yet waiting at level 2. This is because the soft review level allows for open queries, which would need to be closed prior to the record being kicked to the next review level.
Descriptions of the Charts
With TrialKit web v7.0, the dashboard report charts on the web browser have been enhanced greatly to provide improved visibility of study progress. This section describes each of the charts.
Cross-site view of the number of Participants at each site and their primary stage in the study.
- Registered - The number of subjects where a registration form was completed
- Enrolled - The number of subjects where the defined enrollment form was completed
- Randomized - The number of subject where the defined randomization form was completed
- Exited - The number of subject where the defined study exit form was completed
- Target - The per site enrollment goal, if it has been defined for the study
Tap any of the report headers to export the numbers associated with the chart.
For a given site, the number of Participants that are enrolled over time. This gives a view of enrollment activity at specific time points.
Tap the report header to export the numbers for all sites
The status of forms across different sites, to give an indication of data volume and data completeness. See the Site Summary report for additional information about site numbers.
Tap the report header to export the numbers for all sites that are currently included in the dashboard filter
Protocol Deviations and Adverse Events
The number of protocol deviations and adverse events that have occurred at each site. These are based on which forms were defined by the study Builder.
The number of queries open and closed at each site. Open queries are broken down into two age categories.