Double Data Entry (DDE) functionality has been designed into the Clinical Studio system. Even though the application is called “Double” Data Entry; double, triple, quadruple or quintuple data entry can be performed. However, "Double Data Entry" is an industry-accepted term so it will be used here as well.
DDE requires that designated forms, from designated sites, be completed, error-free, by a defined number of DDE users. The number of form entries can be from two (2) to five (5) users depending on how the DDE form is defined. Once the required number of users have completed data entry on a given form and saved that form error-free, an administrative user can resolve any differences between the redundant forms.
Form discrepancy resolution is carried out using a DDE Report created using the Report Builder application (shown below) which lists all DDE forms. When a DDE form is clicked in the report, it will bring up the status for each visit/event for that form (as shown in the second figure below). If a form is ready to have any discrepancies resolved, it will show up with a link in the DDE Status column in that row.
Discrepancy resolution is a very simple process. The system will show you every field in the form that is NOT identical between the DDE clerks as shown in the DDE Discrepancy ResolutionTable in the figure below. Depending on whether (double, triple, etc.) entry was selected; the system will show each user’s entry. At the end of each row is a radio list containing all the user entries for the given field. You can select which entry should be included in the final record.
When done, clicking the Resolve DDE Discrepancies button will move the changes to the final record. Once a form has been resolved, it will be given a green check and function like any other form. Of course, all DDE entries are kept and the form status changes from Ready to Resolve to Resolved.
Double Data Entry (DDE) in Clinical Studio
This is the process of multiple users entering the same form. Once completed with no errors, the form is eligible for resolution. In that process, all discrepancies between the multiple forms can be resolved. Once resolved, the form becomes a normal form and can be accessed normally and reviewed normally.
Please read through all points below to understand the rules of DDE and how it's set up:
● Define which user role will be responsible for DDE by giving that role DDE Clerk permission under Subject Record Management. Assign users who
will be doing Double data entry to that role. It’s okay that they have the same role, even when at the same site. They will not be able to see one another’s
It’s important to make sure only the number of people at a site are DDE clerks as the number of times data entry should be done on a
given record. For example, If 6 users at a site all have the DDE clerk permission, even if they are the same role. The record could
potentially be entered 6 times.
By giving 2 users the same role for double data entry, keep in mind, while the data entry will still work, the DDE Missing Forms list in the
Action Item Report will not show a user if a record needs to be entered (meaning its already been entered once). This is because the
action items is a role-based report.
Given the previous points, it is usually better to create a specific role for each user at a site responsible for data entry. In other words, a
“Data entry A” role and a “Data entry B” role, with only one person assigned to each of those roles at each site. This way, the action item
report will be useful for them AND the Data Manager can individually query each role if needed.
Alternatively, one regular data entry user (non-DDE clerk) can work together with a DDE clerk. This only works if there is a consistent
the workflow in the study, whereby the non-DDE clerk user always enters the data first, and then the DDE clerk enters it second.
Assign a form to a DDE type in the Form properties portion of the form builder.
In the Study Configuration, select the DDE study and the sites you wish to use DDE. If you do not select a site to use DDE, they will function normally.
How it works:
The Transaction diary in the audit trail reflects DDE entry, Resolution and Undo Resolution.
If a user that is not a DDE clerk tries to access a form that is a DDE form and has not been resolved, they will get a read-only message. Once a record is resolved, it can be edited by other users with edit rights and continue through the workflow as normal.
If a Review user tries to access a DDE form prior to resolution, they will get a read-only and no lock message.
If a form has been resolved, the resolution can be undone but only if the form is not locked by a review level.
To be a discrepancy resolver, you must have the Double Data Entry right under Double Data Entry in Role Security.
When resolving discrepancies, if any field in a table is selected with the value "No Row", then that row is omitted from the table altogether.
Other Items To Note:
DDE Clerks will not see a visit date displayed with the record status icon and will also not see queries until the record is resolved. At that time, queries will
be displayed based on the final resolved data
For records not yet resolved, Data extracts and Non-DDE clerks will only see the most recent record entered.
The data extracts will not display a record user or date of entry (record date) for DDE resolved records. This information can be seen in the audit trail
Action Items Report
The “DDE Clerk action items” permission under action item report in Role Security provides DDE Clerks the ability to see which records have been
entered once by the initial DDE clerk (separate user role), and are waiting to be entered again by them.
If the same user role is assigned to two users working together on DDE,