Declaring DDE Forms
DDE forms are declared in the Form Properties section when creating or building your form. A dropdown list exists in the Data section of the Form/Page Properties as shown in the figure below. The dropdown list allows you to define the level of DDE to use. As mentioned earlier, you can define DDE for 2 to 5 users.
You must declare a study as a DDE study in order to use the DDE functionality. This is done in the Study Configuration application using the DDE tab as shown in the figure below. When the tab is selected, you can use the checkbox to tell the system the study will use DDE. You can also tell the system which sites are DDE sites by checking the corresponding checkboxes. This allows you to create a Hybrid Study. A Hybrid study allows certain sites to contribute data with paper that is entered by the Website Host, using DDE. It also allows certain sites to do their own data entry using the EDC portion of Clinical Studio. By declaring which sites use DDE, you are actually defining if the study is EDC, DDE or both (Hybrid).
There are a couple of user roles and rights that must be set appropriately in order for DDE to function properly. They include the following:
- DDE Clerk User Role – This role should be assigned to each DDE Clerk. When a user has this role, the system treats each DDE user as a preliminary data entry user. They can access all DDE forms from all DDE sites and enter data. When complete, they will get a green check. Each clerk operates independently of every other clerk. The system keeps track of when a form has been completed by enough clerks to be resolved. This role also has its own Action Item report that shows all the forms that still require data entry prior to discrepancy resolution.
DDE Report Right – This right should be assigned to the role that will be resolving the DDE discrepancies.
Prior to a study being able to use DDE, it must first be declared. That is done in the Study Configuration Application. Study Configuration can be accessed by dropping down the Study Menu and selecting the “Study Configuration…” option (below).
Once you have navigated to the Study Configuration page, click the Double Data Entry tab. This will allow you to define double data entry for the current study (below).
When defining DDE for a study you have 3 choices. How you setup DDE will determine how data is entered into the system. The following are the 3 choices:
1. All Remote Data Capture
2. All Double Data Entry
3. Both DDE and Remote Data Capture (Hybrid)
If you do NOT check the This Study will use Double Data Entry check box, the system will assume that your sites are entering data remotely. The exception to this rule is a single site study which can be entered remotely or locally.
If you check the This Study will use Double Data Entry checkbox and you check all the sites that will be participating in your study, the system assumes that all data will be entered locally by Double Data Entry Clerks.
If you check the This Study will use Double Data Entry checkbox, but only check some of the sites, then you are declaring a Hybrid study. In a hybrid study, some sites are entered locally; using DDE, while other sites are entered remotely by site based Data Coordinators.
It should be noted, that you can have a multi-site study that does only local data entry. To setup that configuration, create a Local Data Coordinator role using the Role Security tab to add the new role. Then give the Local Data Coordinator role access to all data in all sites. That is done by assigning that right in the Subject Record Management app.
Once you have decided on a data entry strategy, click the Save Study Configuration button at the bottom of the Study Configuration Settings application.
Prior to deploying a DDE study, you must configure the appropriate rights and roles. There is one key role, DDE Coordinator. That role defines a user that enters forms into the DDE system. They have their own Action Item Report. All DDE coordinators function separately from one another. Depending on the level of DDE a given form has, a DDE coordinator will have their own form status for each DDE form.
Here is how DDE works:
1. A form is declared to use Double Data Entry.
2. Prior to a form being usable within the context of the study, two DDE coordinators must enter data for that form.
3. After the first DDE coordinator has entered a record for a given form, the other DDE coordinators will have that record placed on their Action Item report.
4. Once two coordinators have entered a record for that form with no errors, another role is required to resolve any discrepancies between the two forms. Remember, this is actually the same form entered twice, once by each DDE coordinator.
5. Once discrepancies are resolved, the form is given a green check state and can be used like any form entered remotely with no errors. The DDE coordinator's job is done for that form. That form can be source verified and electronically signed.
Your system should have a default role called DDE coordinator. For each user that you want to be a DDE coordinator, assign them that role as shown in the figure below. This is accomplished by selecting the “Sites and Users” tab from the Study Configuration application. Select your site, which is typically the administrative site, and then add the DDE Coordinator role to the list of desired users.
These roles should have the proper rights setup. Let’s take a look at those rights and describe what they allow. Open the Study Configuration Application and select the “Role Security” tab. On the left side of the page, select the DDE Coordinator role, as shown in the figures below. The following should be checked:
1. Action Item List – Select the Grant Rights to Action Item and DDE Clerk Action Items (first figure below). This will allow your DDE clerks to have their own dedicated Action Item Reports.
2. Pages Granted to All Users – Assign the “Pages Granted to all Users” right (second figure below). This allows the user access to all pages that require no security, like help and change password.
3. Subject Record Management – Here we need to select the basic data entry rights along with the DDE Clerk right. Be sure your selections are the same as the selections in the third figure below.