Enter data into log form
As your clinical database for recording subject data is collected in your study, in EDC, you enter the subject data into the respective type of case report forms (CRFs) called log forms.
Log forms are the forms where the data must be added sequentially. This is essential for accurate chronological monitoring of recorded data. Before the first log line is completed, you cannot proceed to enter data in the second log line.
Important
In EDC, you can enable the functionality to add new records to the log form even if it is already signed by the principal investigator (PI) or soft-locked. Upon adding a record, the signature is discarded and the PI has to sign the form again. This is needed, for instance, to avoid delays in recording subject's adverse event details.
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In the EDC application header, select the DATA ENTRY tab.
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On the site list page that opens, select the tile representing the site with which you want to work.
Figure 1. Accessing site
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In the Subject ID column, select the ID of a subject to open their visit overview.
Figure 2. Selecting subject
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In the subject visit tree of the page that opens, expand the needed visit to select the required form.
Figure 3. Left panel. Visits and their forms
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On the page that appears, from the explorer tree pane, select the required form.
Figure 4. Selecting form
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In the contents panel, the form opens. Use your source documents to fill in the data. Select Submit
or refer to the
following table for more information on the available form controls.
Figure 5. Form view and common controls
Element
Details
Back
Select
to return to the form page with all the logs.Detail
Select
to hide the left panel.Submit
Select
to submit your entry to the database. Once submitted, the action cannot be undone.Draft
Select
to save your entry as a draft. You will have to enter the rest of the data later.Inactivate
Select
to inactivate the entire form.Restore
Select
to clear all data entered into the form and return the form to its initial state.If selected, in the Confirm dialog that opens, select Yes to proceed with the data deletion or select No to cancel the data deletion.
Actions
From this panel, next to each field of the form, there are several additional options you can perform.
Open Query
Select
to create a query if you find inaccurate or missing form data.Audit Trail
Select
to view the history of actions made to the form field.Change History
Select
to view the history of changes made to the form field.Preview and print subject PDF
Select
to preview and print
the content of the form in PDF format.Tip
Remember that while working with the log forms, you enter a log by log sequentially, that is unless the first log is entered, you cannot proceed with the next one.
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Once your data is entered and submitted, you are returned to the log summary page. The actions you can perform from here are provided in the following table.
Figure 6. Added log line and activities
Tip
Note that the log summary page lists all the questions and variables of the log form except for those set to be displayed only as labels via SD.
Element
Details
Add
Select
to add a new log line to the form.Inactivate
Select
to deactivate all the log lines of the form in bulk.Columns
Select
to manage the column view on the page, namely hide the unnecessary ones and leave only those that are required for
your work.Go
Select
to switch to the log line details on the action page. From this page, you can update the form data.Inactivate/Activate
Depending on the state of the current log line, the options vary:
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For an active log line, select
to deactivate it. -
For an inactive log line, select
to activate it.
Open Query
Select
to create a query if you find inaccurate or missing record data of a particular form.Reason
Select
to open the Reason dialog and study all the details on the activation or deactivation of the particular log line.To populate record/To baseline record
Depending on the type of form you want to access, select either
or 
to access the populated or baseline form
record.These options only appear if the records of a form are configured as populated in the Study Designer application. -
Once the form details have been completed properly, similarly proceed with other forms reproducing steps 1-6.