Here is a list of the important metrics displayed in the Dashboard:
- Visit progress by site
- Site enrollment
- Adverse Events by site
- Status of CRFs by site (Total, incomplete, and missing)
- Query counts by site
- Review/workflow progress by site
On a web browser:
1. Access the Dashboard Report under the Reports menu.
The subject registration metrics allows users to gain a thorough understanding of how the study is progressing. There are two metrics: Planned and Actual.
2. Enrollment Planned vs Actual
The planned number of Site and Subject registrations can be entered on the Metrics tab in the Study Configuration application accessed from the Study drop-down menu. Here users can establish 4) how many Sites and how many total Subjects are planned for the study as shown in the figure below. The actual metric is measured automatically by the system. 5) Each time a subject is enrolled, the system will increment the Count number. For each new site that is included in the study, the system will increment the Sites number. The percentage figure displayed after those two numbers shows how far along the study registration process is, compared to what was planned.
Study Parameters Table
Study Parameters provide metrics about the protocol dimensions. The protocol is implemented during the design and development of the study. The following describes each metric.
Visit Intervals are defined in the Study menu by selecting the Create or Edit Scheduled Subject Visits menu option. This number describes the number of intervals defined in the Fixed Scheduled Visit Intervals table and gives you an idea of how granular the study is when capturing subject event data.
Variable Visit Tables
Unique Case Report Forms
Each time the protocol is amended a new Protocol Version is created. This number describes how many times the current study has been amended.
Study Progress Table
The Study Progress table gets much more detailed when describing how the current study is progressing. Many of the metrics displayed in the table are “clickable” meaning you can “drill into” them to obtain more detailed information. Anytime something is displayed in blue or when the mouse pointer changes to a hand when hovering over signifies it is “clickable”. When clicking a metric a much more detailed report is displayed on the page below the Review Progress table.
Study Progress Section
This metric describes CRFs and the various statuses of each.
This displays the total number of CRFs entered for all sites in all visit/event tables.
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. If desired, draft CRFs can be disabled using the Study Configurations application from the Study menu.
CRFs with Errors
CRFs that have errors produce 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.
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 which 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.
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.
This displays the number of records that entered a withdrawal form. Since only one withdrawal form can happen per subject. The number of withdrawal forms will show you how many participant withdrawals in study. The form serving as the withdrawal form is defined in the study configuation workflow under the study menu.
The Query system provides a line of communication between the Data Manager and the Site. The Query system is defined using the Query tab in the Study Configuration application accessed from the Study menu. Queries can be generated automatically or manually. Queries can be resolved manually or by correcting errors that generate automatic queries. This section enables users to get an overall view of the Study queries. To gain a much more thorough understanding of the Query system, see the Query help documents.
This metric is the total number of queries that have been created for all Sites within the current Study. It is “clickable” and displays a much more detailed look at all the queries if selected. From within the Query Listing table displayed below the review Progress table, users can drill further into the data to get additional information.
This metric shows the current number of queries that are still open and await resolution.
This metric shows the current number of queries that are closed. Combined with the open queries, this should equal the Total Queries.
Adverse Events Section
Adverse Event counts are calculated by the number of Adverse Event forms that have been completed for the current study. This is a clickable column and provides a more detailed report of each adverse event.
Total Adverse Events
This is the total number of Adverse Event forms that have been completed in the current study.
Number of Subjects with at least 1 AE
This is the number of subjects with at least one Adverse Event. If a subject has more than one AE, they are counted multiple times in the total. This gives you an idea of how many subjects are having an AE.
% of Subjects with at least 1 AE
This metric indicates the percentage of subjects who have experienced an AE. If one subject has 5 adverse events that can skew the numbers. This metric removes that bias and shows the percentage of subjects who experienced one or more Adverse Events.
Review Progress Table
The Review Progress table shows the current metrics of each review level. The type and number of review levels are defined by the Study Designer. When a number is clicked, the corresponding records are displayed in a table at the bottom of the page. For example, if the number in the Waiting column for Data Manager Review is clicked, then the heading for the table displayed would read: Data Manager Review as shown below.
Ideally, at the end of 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 its 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, 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. The reason for this is that 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.
Specific information regarding what the Reviewer must do, can be obtained by clicking on the active links in the Site, Subject or Visit Date Columns in the Review table. The information in the Waiting review column of the Review Progress table corresponds to the Action Item Report for the Reviewer. The Action Item Report can be found under the Reports menu using the Action Item Report… link. When selected, a page similar to that shown in the figure below is displayed.
Each level of review, (remember the number and names for the review levels are user determined at the Study level using the Study Configurations… link and Workflow tab) will have its own review table in the Action Item Report. Each Reviewer will be able to view the items in their own action report; however, depending upon the rights granted to an individual user/reviewer, they may or may not be able to see the review tables for the other review levels. The Reviewer can click the active link in the Form Status column to view/review the Form. Clicking the link will open a window similar to the one shown below in the figure below.
When the forms in the Study have reached the final review level, they should be signed and locked (if the study needs to be compliant with 21 CFR Part 11 regulations). At the final review level, Clinical Studio provides functionality that allows forms to be signed and locked electronically. Providing this functionality allows forms to be signed and locked electronically by the Reviewer which is equivalent to a handwritten paper-based signature according to 21 CFR Part 11. In the Action Item Report of the final review level, the system contains a message below the review table as shown in the figure below.
Once the form(s) have been reviewed, locked and electronically signed they are removed from the Action Item List for the Reviewer.