...

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.

Format

Several formats are available for data collection and the format is clearly specified in the Clinical Data module. 

...

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 description

Table 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.

Prefilled 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.

.

Conditional 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).

...

•  screenshot to be added on inconsistency query

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

On form level more or less the same options are available as on event level.

The user can access the audit trail  via the  icon. The audit trail will display all actions up to that specific level.

Comment

The comment icon will display the number of comments already added on that specific location. Comments can be created by all users with management rights on the eCRFs, meaning for regular a CRF this would be both the site and the sponsor.

Delete

A user can opt to remove the form data. When removing data a reason has to be documented.

Query

•  Query on event level should show up (screenshot to be replaced)

Itemgroup

Item

Edit data

After submission it is possible to modify or clear the data, but the system will request to document a reason.

...