View data entry effectiveness report
Unlike the form completion timeliness report which refers to the measurement of the time taken to complete the CRF, the data entry effectiveness refers to the measurement of the correctly entered data in terms of how many forms have been revised and how many times the forms have been revised.
The statistics presented in the Data Entry Effectiveness report are pulled from the CTMS application based on the number of KRIs created with the Data Entry Effectiveness category and have the risk indicator related to the form revision. These statistics include the data on the total number of revised forms, the average revised frequency of forms, and so on.
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In the EDC application header, select the REPORTS tab.
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In the left pane of the page that opens, expand the KRI-Central Monitoring tab to see the list of available reports.
Figure 1. Accessing KRI report group
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From the list that appears, select Data Entry Effectiveness.
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In the Summary tab that opens, view the summary statistics on data entry effectiveness as explained in the following table.
Figure 2. Viewing summary of data entry effectiveness
Important
There may be no data available in the report or if the data is not the latest, then from the workspace toolbar, select Refresh
to to pull the most recent data from CTMS.Column
Details
Site Code
Represents the unique identifier of the site for which you are analyzing the information related to the completed and revised forms.
Total Completed Form
Represents the total number of forms whose data entry is completed.
Total Revised Form
Represents the total number of forms whose date entry is entirely updated and completed.
Average Revised Form
Represents the mean of forms whose data entry is completed after being entirely updated.
The average is calculated using the following formula:
Total number of revised forms at a particular site / Total number of completed at a particular site
Total Revised Frequency of Form
Represents the total number of times the forms at the particular site are updated.
Average Revised Frequency of Form
Represents the mean of the total number of times the forms at the particular site are updated.
The average is calculated using the following formula
Total revised frequency of form at a particular site / Total revised forms at a particular site
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Then switch to the Details tab to view the more detailed statistics on data entry effectiveness as explained in the following table.
Figure 3. Viewing details of data entry effectiveness
Column
Details
Site Code
Represents the unique identifier of the site at which the form is completed.
[Unique ID Label]
Represents the unique identifier of the subject for whom the form is completed.
The column name depends on the unique ID label configuration of your study in IWRS.If there are additional IDs configured for your study, you see as many such columns as there are IDs.Subject Phase
Represents the subject phase at which the form is completed, for example, Enrolled, Randomized, Completed, and so on.
Visit Name
Represents the name of the visit at which the form is completed.
Form Name
Represents the name of the form whose completion is analyzed.
Form Data Entry Completed
Indicates whether the data is fully captured via CRF.
Form Completed Date
Represents the date when the form is completed. If the form is not completed, then this field remains blank.
Form Revised
Represents if the data elements of the form were updated.
Revised Frequency
Represents the number of times that the data elements of the form were updated.
You have reviewed the data entry effectiveness report. You can also export the report as an XLSX file and work with it offline on your computer.
A specialized document in a clinical trial designed to collect the subject data.
See also eCRF.
An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.
Get to know all the possibilities of the app with the comprehensive CTMS User Guide.
An eClinical application that represents unified and configurable subject randomization and trial supply management tool for subject grouping, drug inventories, shipments, and dispensations, as well as other vital processes during a clinical trial.
Get to know all the possibilities of the app with the comprehensive IWRS User Guide.
A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.
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In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.