File auditing in document warehouse
In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the Essential Documents storage.
Even though the document warehouse storage is temporary, you can introduce auditing if you need the operations with files to be accounted for and comply with specific requirements. The auditing procedure is established once the workflow is associated with the document warehouse directories.
Under the Document Warehouse page, you have the auditing instruments as discussed in the following sections.
Tip
You can also audit files in batch using the File Task functionality.
In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the essential documents storage. For such files, the auditing procedure must be established according to the workflow that is associated with document warehouse folders.
Thus, if an action is attempted with the file, the authorized user has to approve, sign, or reject this action.
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In the eTMF application header, select the TMF tab.
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From the left pane, select the Study List subtab.
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On the Study List page, in the table, select the needed study name.
Figure 1. Accessing study
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On the page that opens, in the left pane, select Document Warehouse.
Figure 2. Accessing document warehouse
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On the Document Warehouse page, from the explorer tree pane, select the required directory, and in the table, go to the file you need to audit. Then next to the file, from the Actions column, select More
> Audit 
.Tip
The files assigned to you are marked as My Task
next to the file name.
Figure 3. Locating file to audit in document warehouse
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In the dialog that appears, approve the file as explained in the following table.
Figure 4. Approving file in document warehouse
Element
Details
Operation History
Represents the table with the complete log of operations performed on the file from its upload to date. This tab also comprises all the auditing options, such as approval, rejection, and termination.
Workflow
Go to the Workflow tab to check the workflow according to which the file is audited.
Figure 5. Checking file auditing workflow
File Preview
Select
to open the file contents in the new browser tab.Approve
Select this option to acknowledge that the file is checked and validated by you.
Comments
Enter a comment to support your action, if needed.
SUBMIT
Select
to save the applied changes.TERMINATE
Select
to terminate the file audit.CANCEL
Select
to discard the implemented changes and close the dialog.
Once submitted, the file is audited and approved. The file status changes according to the associated workflow.
In eTMF, all the operations with files under Essential Documents must undergo the auditing procedure according to the workflow that is associated with folders containing these files.
Sometimes the workflow might require that if an action is attempted with the file, the authorized user has to approve this action by providing their electronic signature.
Important
For security, the system logs you out after three failed attempts to confirm your identity with a password or code.
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In the eTMF application header, select the TMF tab.
-
From the left pane, select the Study List subtab.
-
On the Study List page, in the table, select the needed study name.
Figure 1. Accessing study
-
On the page that opens, in the left pane, select Document Warehouse.
Figure 2. Accessing document warehouse
-
On the Document Warehouse page, from the explorer tree pane, select the required directory, and in the table, go to the file you need to sign. Then next to the file, from the Actions column, select More
> Audit .Tip
The files assigned to you are marked as My Task
next to the file name.Figure 3. Locating file to audit in document warehouse
-
In the dialog that appears, complete the signature details as explained in the following table.
Important
The details you need to provide for action confirmation depend on the authentication method configured for you in the system—via SSO or via providing your login and password.
Figure 4. Signing file in document warehouse
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Operation History
Represents the table with the complete log of operations performed on the file from its upload to date. This tab also comprises all the auditing options, such as approval for signature, rejection, and termination.
Workflow
Go to the Workflow tab to check the workflow according to which the file is audited.
Figure 5. Checking file auditing workflow
File Preview
Select
to open the file contents in the new browser tab.Approve
Select this option to acknowledge that the file is checked and validated by you.
Comments
Enter a comment to support your action, if needed.
User Name*
Enter your user name to provide an electronic signature.
Password*
Enter your system password to confirm an electronic signature.
The field is only available if you use the authorization method by providing your login and password.Send Code
Select
to send the temporary PIN code to your email for which the SSO method is configured.The button is only available if you use the authorization method via SSO.Code*
Enter the temporary PIN code that you received via email to confirm an electronic signature.
The field is only available if you use the authorization method via SSO.Title
Represents the title of the user entered in the User Name field if it is configured in the ADMIN application. The field cannot be edited manually.
I have reviewed and approve this document(s)
Select this checkbox to acknowledge that you have reviewed the document for which you are signing.
SUBMIT
Select
to complete the approval process.TERMINATE
Select
to terminate the file audit.CANCEL
Select
to dismiss your actions without saving and close the dialog.
Once submitted, the file is approved and signed. The file status changes according to the associated workflow.
In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the essential documents storage. For such files, the auditing procedure must be established according to the workflow that is associated with document warehouse folders.
Thus, if an action is attempted with the file, the authorized user has to approve this action or sign for it. At both these stages—approval or signature—based on your judgment, you can decide to reject the action with the file for some valid reason, such as a duplicated document, misclassified file, or else.
-
In the eTMF application header, select the TMF tab.
-
From the left pane, select the Study List subtab.
-
On the Study List page, in the table, select the needed study name.
Figure 1. Accessing study
-
On the page that opens, in the left pane, select Document Warehouse.
Figure 2. Accessing document warehouse
-
On the Document Warehouse page, from the explorer tree pane, select the required directory, and in the table, go to the file you need to audit. Then next to the file, from the Actions column, select More
> Audit .Tip
The files assigned to you are marked as My Task
next to the file name.Figure 3. Locating file to audit in document warehouse
-
In the dialog that appears, reject the file as explained in the following table.
Figure 4. Rejecting file in document warehouse
Tip
In the following table, mandatory elements are marked with an asterisk (*).
Element
Details
Operation History
Represents the table with the complete log of operations performed on the file from its upload to date. This tab also comprises all the auditing options, such as rejection, approval or signature, and termination.
Workflow
Go to the Workflow tab to check the workflow according to which the file is audited.
Figure 5. Checking file auditing workflow
File Preview
Select
to open the file contents in the new browser tab.Reject
Select this option to acknowledge that you have checked the file and found it inappropriate.
Reject Reason*
Select the reason why you are rejecting the file, such as Missing Signature, Duplicate Document, and so on.
Comment
Enter a comment to support your action, if needed.
SUBMIT
Select
to complete the rejection process.TERMINATE
Select
to terminate the file audit.CANCEL
Select
to dismiss your actions without saving and close the dialog.
Once submitted, the file is audited and rejected. The file status changes according to the associated workflow.
In eTMF, the Document Warehouse tab is mainly used for the temporary storage of some unorganized files so that, upon request, they can be organized by data managers (DM) and other accountable individuals per DIA RM and uploaded to the essential documents storage. For such files, the auditing procedure must be established according to the workflow that is associated with document warehouse folders.
All the actions with files under the Essential Documents storage can be controlled via auditing procedure according to the workflow that is associated to their parent folders. Thus, if an action is attempted with the file, the authorized user has to approve, sign, or reject this action.
Nevertheless, sometimes you might need to terminate the file audit before it is completed.
-
In the eTMF application header, select the TMF tab.
-
From the left pane, select the Study List subtab.
-
On the Study List page, in the table, select the needed study name.
Figure 1. Accessing study
-
On the page that opens, in the left pane, select Document Warehouse.
Figure 2. Accessing document warehouse
-
On the Document Warehouse page, from the explorer tree pane, select the required directory, and in the table, go to the file whose audit you need to terminate. Then next to the file, from the Actions column, select More
> Audit .Tip
The files assigned to you are marked as My Task
next to the file name.Figure 3. Locating file to audit in document warehouse
-
In the dialog that appears, select
.
Figure 4. Terminating file audit in document warehouse
-
In the Comment dialog that appears, enter the accompanying comment for your action and select
.
Figure 5. Commenting on file audit termination
Once terminated, the file audit is aborted, and the file status changes to Dropped.
A person responsible for managing and ensuring the integrity, accuracy, and confidentiality of data collected during clinical trials. The DM’s scope of work might include maintaining the quality of data, complying with regulatory requirements, and supporting the overall success of clinical research.
In the eClinical system, the Data Manager (DM) user role is granted to a person who is mainly responsible for cleaning the data, making sure the data is entered correctly according to all requirements and industry standards, and creating manual queries for clinical research coordinators on any questionable data pieces. Before the study goes live, works with the sponsor and receives and addresses their feedback to set up the study and CRFs in EDC in a way that the sponsor approves.
A model for organizations from DIA that helps the organizations to effectively compile the minimum list of essential documents to ensure the compliance of the investigator, sponsor, and monitor with the industry standards of good clinical practice (GCP) and with the regulatory requirements.
A schema, each step of which represents a stage of a specific entity lifecycle in the system.
A workflow can be considered an instrument to help control various actions on system entities for the sake of accountability, as it limits the actions that can be performed on the entity associated with a workflow. This provides an additional tier of scrutiny, and the approval/rejection mechanism reduces the risk of unintended impact on sensitive resources and important information.
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For instance, in eTMF, the workflow dictates the procedure of file and folder management from the moment of upload to the approval stage; in CTMS, the workflow controls the process of creation, completion, and approval of a trip report; in EDC, the workflow covers the process of source document handling.