Reviewing documents

  • Published by Viedoc System 2023-10-09
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Launching Viedoc eTMF

To launch Viedoc eTMF, click on the eTMF icon on the Viedoc landing page.


Note! The eTMF launch icon is only available in production mode.

Reviewing a document in Viedoc eTMF requires review permission for the artifact on the TMF level that the document is linked to. For more information about permissions, see Introduction to Viedoc eTMF.

Searching for documents

To search for documents in Viedoc eTMF:

1

Enter a text to search for in the Search field.

The text can be an document name or a file name, or a sub-string thereof. It can also be a text or a sub-string of a text in the file contents.
2

Press Return (or Enter) or click on the magnifying glass.
3

The search results are displayed on the Details page, sorted by relevance.

Tip! If you hover over a zone, section, or artifact icon, its name will be displayed.

Reviewing a document

To review a document with the status Awaiting review:

1

Click on a document on the Details page to open the Document properties window in read-only mode.
2

Make sure that all document metadata is correct.
3

To view the the latest version of the uploaded file, click the Preview button in the top right corner of the window.

For more information, see Previewing a document.

Alternatively, click the download button to download the file.
4 Review the file contents.
5

To navigate between versions of the document, use the version dropdown menu at the top of the Document properties dialog.
6

If you need to add a review comment, open the Document action window by clicking on the Document action button in the Document properties dialog:
7

Select Add review comment.
8

Add your review comment in the Comment field.
9

Click Ready to save your review comment.

Note! If you add a review comment, the document status is changed to Flagged by QC. To change the status back to Awaiting review, a user with write permission needs to edit to the document metadata or upload another file.
10 If there is no need for a review comment, the document is ready to be approved.

Approving a document

Approving a document in Viedoc eTMF requires review permission for the respective trial, country, or site. For more information about permissions, see Introduction to Viedoc eTMF.

To approve a document with the status Awaiting review:

1

Open the Document properties window by clicking on a document on the Details page.
2

In the Document properties window, click Approve.
3

The document status is now Finalized.

Note! Finalized documents cannot be edited. To make changes, a new document version must be created.

Locking a document

To make sure no changes can be made to a Finalized document, it needs to be locked. If the eTMF is configured to Automatically lock documents on approve, the document will automatically be locked when it is approved. Otherwise you can lock it.

To lock a document:

1

Open the Document properties window by clicking on a document on the Details page.
2

In the Document properties window, select Lock.
3 The Lock button is now changed into an Unlock button.

Note! It is not possible to create new versions of locked documents.

Unlocking a document

To enable editing of a locked document, you can unlock it.

To unlock a document:

1

Open the Document properties window by clicking on a document on the Details page.
2

In the Document properties window, click Unlock.
3

If the eTMF is configured such that a reason must be given to unlock the document, click the Document action button in the Document properties window:

  • Select Unlock:
  • Add your reason in the Reason field:
  • Click Unlock document to unlock the document:
4 The document is now unlocked.