Data review and Lock

  • Published by Viedoc System 2023-10-09
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Note that much of the information in this lesson is the same as in the lesson Clinical review, SDV, and Lock.

Introduction

The requirements on data review and source data verification vary between studies. This lesson describes what is possible in Viedoc.

If applicable for your study, data review is a task to be completed. The number of tasks to be completed is displayed in the orange task icon:

The orange task icon disappears when the checkboxes for clinical review and Source Data Verification (SDV) are selected and the task is completed.

Note! If a user with edit permission is editing the subject card, you can still perform the clinical review and the SDV. And vice versa, the clinical review and the SDV will not lock the subject for users who need to edit it.

Data review

The purpose of data review is to give the Data Manager the possibility to mark forms as reviewed.

Marking a form as data reviewed can be performed in one of the following ways:

  • At the bottom of each form, by checking the Data review checkbox.
  • Batch-wise through the review console. Read more about the review console below.

Note! If a form is edited after you have marked it as data reviewed, the review status breaks and the form must be reviewed again. The review task appears again in the orange task box icon.

Lock

Locking a form

Locking data in a form can be performed in one of the following ways:

  • At the bottom of every form, by checking the Lock checkbox.
  • Batch-wise using the review console. Read more about the review console below.

Locking a form should only be performed if there are no more expected changes to that form; that is, if the data is clean.

Important! Updates to the electronic Case Report Form (eCRF) are not applied to locked forms. If you are aware of any upcoming changes to the eCRF that potentially affect already saved and locked forms, make sure that these are unlocked before the new design version is published to the site.

If all forms in all events for a subject have been locked, the subject card on the Selection page will be displayed with a lock icon, indicating all data is locked:

Unlocking a form

Regular clinic forms can be unlocked by clearing the Lock checkbox at the bottom of a form. Unlocking a form opens it up for editing by users with edit data permission (for example the Investigator).

Locking/unlocking a subject-submitted (Viedoc Me) form

Subject-submitted (Viedoc Me) forms that are filled in by the subject are locked by default.

You may have the possibility to unlock a subject-submitted form if this option is activated for your study. In this case, the Lock checkbox appears at the bottom of the subject-submitted form. The form can be locked or unlocked by selecting or clearing the checkbox respectively. Unlocking a form opens it up for editing by users with edit data permission (for example the Investigator).

Data review console

You can perform data review and lock of the forms batch-wise, by using the data review console. To open the data review console, click the icon in the top right corner of the Details page.

The data review console displays an overview of all forms of a subject that require data review, SDV or lock. It shows which forms have been reviewed, SDV'ed or locked. The green and grey eye icons help you identify which forms you have visited (the most recent version of the form): the green eye icon means that you have visited the last version of the form, the grey eye icon means that you have not visited the latest version of the form.


To review and/or lock the forms:

1

Select the form(s) to be reviewed in one of the following ways:

  • Select all forms by clicking the n forms link on the top of the page:

  • Select all forms within an event, by clicking the n forms link to the right of the respective event:

  • Individually, check the review and/or lock icon for each individual form. Step 2 is not applicable in this case.
2

In the pop-up that opens, mark with Data review and/or Lock as needed, and click Ready:

The status of the selected forms is updated according to the selected actions.

If any of the marked forms have not been visited by you before, you will be asked whether you want to continue with the action or not. If you choose to continue, the forms will be marked according to your selections, that is, the system will not prevent you from marking unvisited forms as reviewed or locked.

Note! If the study has the setting for item-level SDV enabled, and a form contains items that require SDV but are not visible to you, you will not be able to change the SDV status for the entire form.

Study status and metrics

The current workload can be checked on the Study status or the Metrics pages.