Veeva EDC Functionalities

Veeva EDC offers several functionalities within the EDC to allow for easier data entry and navigation of the system. Below are brief descriptions of these functionalities and how they may be used for the study database.

Conditional Forms
By setting certain forms as “conditional” this allows those forms to only be added to the appropriate folder when one or more conditions have been met.

Example 1: The Recipient Inclusion Exclusion Criteria Not Met form will only appear in the Enrollment folder if the “Screen Fail date” field on the Enrollment and Randomization form has been completed.

Example 2: The specific Pre-HCT Disease Evaluation form will appear in the Screening folder based on the disease selected in the “Specify the disease indication at diagnosis” field on the Recipient Disease form and the form is submitted.

!If a field is edited and the added form is no longer needed or is not correct, Veeva will automatically mark the not needed form as “Marked for Removal” and place a warning symbol in front of the form. This form should be removed from the folder by opening the form and clicking the Reset Form button at the top of the page.

Progressive Display
Progressive display allows for specified fields to only be shown within the EDC based on answers to one or more fields.

Example 1: On the Recipient Inclusion Exclusion Criteria Not Met form if the field “Conditioning Regimen” is answered, an additional section will appear in the EDC to indicate which inclusion criteria were not met or which exclusion criteria were met.

Example 2: On the Demographics form only the broad race options appear when first opening the form. Once a broad race category is selected, additional detailed race options appear to select.

Example 3: On the Pre-HCT Bone Marrow Assessment form, if the field “Was a bone marrow aspirate performed?” is answered Yes, additional fields will appear on the form to report date of bone marrow aspirate and blasts in bone marrow by morphology.

Repeating Item Groups
Repeating item groups allows for multiple data entry for the same set of fields. To add additional data entry, click on the +New Section button at the end of the item group. This will add a new group of the same fields to be completed with different data.

Example 1: On the Eligibility Recipient Inclusion Exclusion Criteria Not Met form if the field “Conditioning Regimen” is answered, an additional section will appear in the EDC to indicate which inclusion criteria were not met or which exclusion criteria were met. If there were multiple criteria that were not met/met, add a new section for each separate criterion.

Example 2: On the Pre-Conditioning Infection Assessment form if there are multiple infections to report add a new section to report each infection separately.

Example 3: On the Mycophenolate mofetil (MMF) Administration form adds a new section under the MMF Dose Administration section to report start and stop dates at each dose level of MMF.

Form Linking
Form linking allows linking between specified forms. For the ACCELERATE study form linking is available for the Adverse Events, Concomitant Medications, and Medical History forms.

For example, linking an Adverse Event to one or more medications will assist the Medical Monitor to identify which medications were given for treatment of an AE.

Form linking can be done from either the Adverse Events form or the Medications form. To link a medication to an AE, click on the + Add Link button at the bottom of either form and select the appropriate AE or medication(s) to be linked.

*Form linking requires that both the Adverse Event and all Medications be entered on the respective forms first.

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