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Introduction
As of data completion the system will run several type of automated checks and indicate the validation status of the data. The data validation status is expressed by a corresponding color status and warning message at all different data levels (e.g. item/question, form, event,...).
Initial Data Completion
When data completion is initiated values are saved and a field can be changed immediately without editing or explanation. The user who is completing the form will be informed by automatic messages displayed on top of the form in case mandatory data is missing and/or in case of outstanding range checks.
Once all mandatory data is completed and there are no outstanding range checks, a message will be displayed that the form is ready for submission.
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Validation Status
The colors linked to the different data levels (category, event(group), form, itemgroup, item) indicate the validation status of the data. Before submission the data will be displayed as optional, missing or incomplete. In case data is completed, automatic checks will be done by the system at submission of the data which will result in a new validation status: issues or no issues. In case of optional data which is not completed, the status remains optional after submission.
A summary of the validation status is displayed in the general progress on top of the left menu listing the events.
The user can find more details on the validation status by hoovering over the status bar. The number of forms of of the total number of forms per validation status is described in the message displayed.
Data Status
Depending on the study specific design settings the user will have data status options at disposal at any levels from event(group) to item which allow the user to indicate that a certain cycle, visit, assessment or parameter was not done, unknown or not applicable. An icon (examples below) will indicate if such options are available and by clicking the icon the study specific options will be listed. If no data status options are available, the icon will not be displayed for that data level or that parameter.
Example on item level
Example on form level
Format
Several formats are available for data collection and the format is clearly specified in the Clinical Data module.
A warning is shown when a user enters an answer that is not conform to the defined format.
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| Available formats | Comments |
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| Float | It is possible to enter a comma or a point to enter a float value. |
| Date | Dates can be entered by: |
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It is possible to enter ".", "-" |
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or "/" as separator. All separators are converted to a "-" when entering. | |
| Time | It is only possible to enter a ":" as a separator between hours (0-23), minutes (0-59) or seconds (0-59) - ISO standard |
| Partial date/time completion |
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| Incomplete date/time completion |
The unknown elements in an incomplete date and/or time are entered by an "u" or "-". The "u" or "-" are converted to "unk" when entering. |
| Questions with predefined labels | Depending on the design settings of the question it is possible to select:
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For each format additional options can be available to indicate if data is unknown, not applicable or not done. A reason has to be provided to confirm the use of such option.
The options not done and not applicable can also be available for a group of questions, a form or for a group of forms/events.
Guidelines and
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Description
| Guidelines | Italic text |
| Help icon | Descriptive information which becomes available when hoovering over the icon |
| Information icon | System related information in case of specific formatting requirements |
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Table
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View
Data can be displayed in table format to facilitate the overview of data reported. The highlighted row is the data which is expanded below the table format. Data can be modified by clicking on the corresponding row and this expanding the corresponding questions in the regular view.
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Prefilled
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Data
Fields can be prefilled with copied or calculated information. For example the age can be calculated based upon the the birth date. The fields containing prefilled data cannot be edited which is indicated with a lock 
sign.
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Conditional
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Data
When the user enters certain data this can trigger the appearance of new fields or forms. Such conditional fields or forms will be triggered immediately after completion (prior to submission of the data).
When the completion of conditional data is initiated, but the trigger field is modified and causes the conditional data to become (potentially) obsolete the system raises an inconsistency query. The user is asked to confirm the deletion of this (potential) obsolete data or to confirm to maintain the data, stating a clear reason why.
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- screenshot to be added on inconsistency query
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Data Submission
The submission of data triggers the following processes in the system:
- Auto queries are generated on the corresponding eCRF in case of inconsistencies,
- The form becomes available for signature when submitted and no issues are discovered.
Options
Form
Audit trail
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On each level more or less the same options are available
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(audit trail, comments, delete and query). In addition the form header will summarize following properties:
- Submission status
- Signed status
- Ownership of the form
Audit Trail
The user can access the audit trail
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via the 
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button. The audit trail will display all
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actions performed on any data up to that specific level.
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Comments
The comment
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button will display the number of comments already added on
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that specific level. If you click it, the display will show those comments.
To add a comment, click the comment button and subsequently select '+ New Comment'. To edit a comment, the user needs to select that specific comment and a pop-up screen will allow the user to update the original comment. A comment can also be deleted with the delete button (X) at the end of the comment row.
Comments can be created by all users with management rights on the eCRFs, meaning for regular
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CRFs this would be both the site and
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sponsor.
Delete
A user can
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choose to remove the form data. When removing data, a reason has to be
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provided.
Query
- Query on event level should show up (screenshot to be replaced)
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Itemgroup
Item
Edit data
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ItemGroup
On ItemGroup level a user can access the audit trail, view or add comments and opt to delete the ItemGroup data.
Item
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On item level a user can access the audit trail, view or add comments and opt to edit the data.
Edit DataAfter submission the data can still be modified or cleared, but the system will request |
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a reason.
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Specific situations:
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