Vault EDC collects data through Forms. Forms are object records that group together Item object records. Each Item record represents an ‘answer,’ or a field and value on the Form.
You can perform several actions on a Form. The following actions are available from the form’s Actions menu:
- Export PDF: Generates a PDF of the form.
- Form Audit Trail: Opens an audit trail specific to the form.
- Reset Form: Resets all items on a form to blank and sets the form status to Blank.
- Intentionally Left Blank: Marks a form as Intentionally Left Blank. Vault will not create queries based on missing data. Note that the form must be Blank to use this action.
Vault EDC automatically saves values as you enter them.
Types of Fields
Each Item object record includes an item control. An item control is the type of field in which you enter data. Click into a control field, and then select or type to enter data. You’ll see more details about each type of control on the next step.
Depending on your study’s design, certain Items may have a tooltip. When you hover over the Information (i) icon, Vault displays help content for that item field.
Date, DateTime & Time
To enter a date and time with a text field, use any of the following formats:
- Days with 2-digit values (dd, 03, 12)
- Months with 3-letter values (MMM, MAR, APR), or 2-digit values (MM, 01, 11)
- Years with 4- or 2-digit values (yyyy, yy, 2017, 17)
- Time in both 12 hour (hh:mm) and 24 hour (HH:mm) formats
You can also click into a date or date/time field and select your date and time using the calendar. Select a month and day. If you need to change the year, click the year in the calendar’s header and select a different year.
Once you click into the Date field, you can select your date in the calendar. Click the Month and Year to move backward and select those date components as needed. You can click Today to enter the current date with a single click.
Unknown Dates & Times
Depending on your study’s design, you may be able to mark dates (either the month and day or only the day) and times as unknown. For example, if a subject does not recall the time they took an over-the-counter medication, you can select the date and mark the time as unknown.
When recording data in a Form, you can select a measuring unit from a Unit picklist. By using a unit picklist, you can enter data in the unit you collected it in, regardless of any requested standard units. Note that default units are set during study design. If you use other units, your data is converted after saving.
A codelist control is a defined list of values you can choose from in a Form. For example, you might select a certain response from a Response codelist.
You can click into a codelist and then click a value to select it. You can also click or tab into the codelist control and start typing. Then, select from matching results. If your selected value is first in the list, press Enter to select the value.
Codelists may also appear as radio button controls, from which you can choose a value in a Form. For example, you might click a radio button control to select a certain value for a Response. Radio buttons can appear horizontally in a group, or vertically as a list.
You can click a value to select it. You can also click a radio button control and use your keyboard to select a value. Use the Down or Right arrow keys to move to the next value. Use the Up or Left arrow keys to move to the previous value. Press Enter to select a value and move to the next Item.
Click or tab into the field and type to enter your text. If there are any character limits associated with the field, Vault displays a character count as you type.
A number field is like a text field, but it only accepts numeric values. You can enter numeric characters 0 through 9, a period “.”, and a dash “-”. Depending on your study’s design, Vault saves the number you enter up to a defined number of significant digits.
You can enter data by selecting a checkbox.
For these Item fields, you can paste a URL (link) to another webpage, image, or file. For example, a Forms may have a URL-type field for linking to DICOM® files. Vault EDC validates the entered URL before saving the value.
Vault EDC then displays the entered URL as text on the Form. Click the Open button to open the URL in a new browser window.
Depending on your study design, some fields may have configuration in addition to their type.
Some fields may be configured as read-only on a Form. Read-only fields are disabled when editing a Form. Read-only fields may be derived fields or populated with values from an external tool, such as a randomization or kit number.
Derived fields are fields that Vault automatically populates with a calculated value after you submit a Form. For example, you may enter Height and Weight on a Vitals form. Once you click Complete, Vault EDC calculates the subject’s BMI and enters it into the BMI field. BMI is a derived field.
Certain forms in your study may be restricted (blinded). If you don’t have permission to access restricted data, you won’t be able to see any restricted Form.
If you do have permission to access restricted data, Vault marks any restricted forms with the Restricted () icon.
Based on your study design, Vault may add Events and Forms or to your casebook schedule, or conditionally enable Items and Item Groups based on the data you enter in a Form. For example, if you enter Female for Gender, Vault enables the Pregnancy Test Result item. If you enter Male, Vault disables the Pregnancy Test Result item. You cannot enter data for disabled Items. Vault does not create tasks based on disabled Item fields. For another example, if you choose Yes for a Follow Up Visit Required item, Vault creates a Follow Up Visit event and its related Forms.
If you later edit the value for a controlling Item, Vault prompts you to delete the values you entered on any dependent Items or Forms. Review the list of Item values this action deletes, and confirm. Note that you cannot save a change to a controlling Item without deleting those dependent values.
Resetting a Form
Resetting a Form removes all entered data, closes any open queries, and returns the Form to the Blank status.
Note that you can only reset In Progress forms. To reset a submitted form, you must first open the Form in Edit mode.
To reset a Form:
- Navigate to the Form within the Casebook.
- In the Reset Form confirmation dialog, click Reset.
If a blinded user reset an Event or Casebook containing a restricted Form, and you are an unblinded user, you must reset the Form for it to be fully removed. When you open the Form, Vault shows a banner noting that the form is no longer required.
To reset such a Form, click Reset Form.
The following actions are available from the Item level More Actions menu:
Marking a Field as Intentionally Left Blank
You can mark an Item as Intentionally Left Blank at the field level to let the sponsor know that the value was not collected and why. To mark a field as Intentionally Left Blank:
- Optional: If you mark an Item as Intentionally Left Blank on a submitted Form, select a Reason for Change.
- Click Continue.
Marking a field Intentionally Left Blank prevents Vault from generating any system queries against that field. If you select Intentionally Left Blank for a field which already contains a value, Vault will prompt the user if they want to clear the existing value. To undo the Intentionally Left Blank action, click the pencil icon. If you or another data entry user resets the form, Vault clears the Intentionally Left Blank field.
The following behavioral rules apply when you mark an Item or Form as Intentionally Left Blank:
- When you mark all Items in an Item Group as Intentionally Left Blank, Vault automatically marks the Item Group as Intentionally Left Blank.
- When you mark all of the Items and Item Groups on a Form as Intentionally Left Blank, Vault automatically marks the entire Form as Intentionally Left Blank.
- When you mark a Form as Intentionally Left Blank and select a reason, Vault automatically marks all of the Items on the form as Intentionally Left Blank and gives the reason that you selected. If any Items were previously marked as Intentionally Left Blank and a reason was selected, Vault updates those Items to use the new reason for marking the Form as Intentionally Left Blank.
- When you mark or unmark an Item or Form as Intentionally Left Blank, Vault automatically removes any completed Data Management Review (DMR) or Source Data Verification (SDV) from the Item or Form.
Field Audit Trail
You can view an audit trail specific to an Item field by selecting Audit Trail from the item’s More Actions menu. Note that this option is only available when there is at least one logged change to that field.
Adding Forms & Item Group Sections
Depending on your study design, you may be able to add new Forms and Item Groups to certain events in a casebook. For example, you may have a Medical History form, and you can add forms for each medical history event that you need to record for the subject. You may also have a repeating Body System Exam item group on a Physical Exam form. You can create a new Item Group (section) for each body system examined.
You can add a repeating or common form from the casebook. Note that your study’s design may limit the number of times a form can repeat.
- From the table view, click +New.
- Vault adds the new form to the subject’s casebook and opens the form in edit mode. To return to the repeating or common form table view, click the form name in the form carousel. You can return to the form later using the form carousel or the breadcrumb menu.
- Enter data in the form.
- Click Complete.
If your Study has recently undergone an amendment, note that Vault automatically creates your new Form using the most recently assigned casebook version.
You can add a new sequence of a repeating Item Group from within the Form containing it. Note that your study’s design may limit the number of times an item group can repeat.
- Navigate to the form containing your repeating Item Group.
- If sequences already exist, scroll past the last existing sequence. Depending on your study’s design, Vault may automatically create all required Item Groups for a Form. For example, for a Physical Exam form, Vault may add an Item Group for each body system examined.
Click + New Section.
- Vault adds a new sequence of the Item Group to the Form.
- Enter data in the Item Group.
- Click Complete when finished entering data for the entire Form.
If your Item Group uses tabular view, click +New in that view to add a new Item Group.
If your Study has recently undergone an amendment, note that Vault automatically creates your new Item Group using the most recently assigned casebook version.
Completing a Form
Once you have filled all required fields in a form, you can complete the form by clicking the Complete button.
Clicking Complete does not save data. Vault automatically saves data as you fill the Form. Clicking Complete indicates that you are finished entering data, and that the Form is ready for review, moving the Form into its Submitted status.
Non-Conforming Data Value Entry
Vault EDC warns you when you have entered a non-conforming data value. This way, you can correct your input to a valid format prior to attempting to save.
If, after seeing this warning, you don’t correct your data input, Vault EDC highlights the item control in red and displays the error message below the item control.
Vault will not save non-conforming data values. The Submit button is disabled, and Vault EDC doesn’t auto-save the form, instead displaying an error. Clicking the link in this error will scroll the form down to the non-conforming data value. If you refresh the page, Vault clears the non-conforming data value.
Editing a Form
If needed, you can change data after you have submitted a form. To make changes, click the Edit Form button.
Reason for Change
Whenever you make a data change after submitting a form, you must include a Reason for Change. This note is included in the audit trail entry associated with your data change. Once you click the Edit Form button, Vault opens a dialog from which you can select a Reason for Change. Then when editing an individual item, the Reason for Change drop-down displays below the field. The value you selected after clicking Edit Form is the default option in this drop-down. You can select another value.
Vault records both Reason for Change selections in the field audit trail.
Which permissions control your access depends on when your vault was created. If your vault uses the Role by Study feature, see the first section, Role by Study Permissions. If your vault does not use the CDMS Role by Study feature, see the second section, Profile Permissions.
Role by Study Permissions
Users with the standard CDMS Principal Investigator, CDMS Sub Investigator, and CDMS Clinical Research Coordinator application roles can perform the actions described above by default. If your vault uses custom Application Roles, your role must have the following permissions:
|Standard Tab||Data Entry Tab||
Ability to access the Data Entry tab
|Functional Permission||Data Entry||
Ability to enter study execution data
If your Study contains restricted data, you must have the Restricted Data Access permission to view it.
Learn more about Study Roles.
These actions are available for the EDC Clinical Research Coordinator and EDC Investigator security profiles.