When you upload to a drop zone, the system automatically creates a new study item for each document. The study items are created for the document type associated with the reference model ID and level determined by your folder and breadcrumb selections.
A “Blinded” drop zone is always displayed. If you upload to the Blinded drop zone and the document type allows unblinded documents, the Unblinded value of the document will be automatically set to No.
An “Unblinded” drop zone is also displayed if the following
are true:
The document type associated with the artifact
has the Can be unblinded setting of
“Yes”
The study selected from the breadcrumb has the Study contains unblinded documents
setting of “Yes”
If you upload to the Unblinded drop zone, the Unblinded value of the document will be automatically set to Yes.
To upload to a drop zone by browsing:
Click
Browse Files in a drop zone.
Use
the file explorer window to navigate to and select the documents you want to
upload.
Click
Open.
To upload to a drop
zone by dragging and dropping:
Select
one or more documents you want to upload from your local file explorer.
While
holding the mouse button, drag the documents to the desired drop zone in
eUpload. The text and image in the drop zone turn green.
You can submit a
document only if the document is eligible to be submitted. A document is
eligible to be submitted if:
An error was not encountered upon upload
If the document has missing metadata, the
system is configured to allow documents with incomplete metadata to be
submitted
The document is not multi-indexed
Note: If multi-indexed, you must work on the document from your eTMF Work Area.
To submit a single
document, click the Submit button.
If the document has missing metadata, a confirmation message displays,
indicating that the document has incomplete metadata. Select Ok on the confirmation message.
To submit all documents, click the Submit
All button. If any document has missing metadata, and the system is
configured to allow you to submit documents with missing metadata, a
confirmation message displays, indicating that one or more documents have incomplete
metadata. Select Ok on the
confirmation message.
For each document uploaded in eUpload, the following metadata fields are displayed. Fields that are required are displayed on the Review Files page in eUpload in yellow.
Field
Availability
Value
Editable
Doc Type ID
Always displayed
The doc type ID of the selected document
No
Ref Model Subtype
Only displayed if the document type is configured with Ref Model Subtype as an editable attribute
Blank if you uploaded to an artifact folder
Otherwise, the name of the Ref Model Subtype folder you uploaded to
Yes
Subject
Only displayed if document type is configured with Subject as an editable attribute
For .msg files, the subject of the email is used as the subject of the document (with the exception of references to FWD and RE
For other files, the file name is used as the subject of the document
Yes
Document Date
Always displayed
For Outlook .msg files, the sent date of the latest email is used as the document date
For other files, the document date is blank
For non-.msg files only
Receipt Date
Always displayed
For Outlook .msg files, the receipt date of the latest email is used as the document date
For other files, the receipt date is blank
For non-.msg files only
Language
Always displayed
The language is automatically detected when possible
If auto-detection is not possible, then the language is blank
Yes
Program/Study
Always displayed
The program and study to which the document was uploaded
No
Country/Site
Displayed only if uploaded to a country or site
The country and site to which the country was uploaded (if applicable)
No
Organization
Always displayed
The organization for the document type; if multiple organizations are associated with the document type, only the first organization specified is displayed
No
Additional Information
Always displayed
Blank
Yes
Document Owner
Always displayed
The user who is logged into eUpload
Yes
Unblinded
Displayed only if study allows unblinded documents and the document type can be unblinded
Yes, if you uploaded to the Unblinded drop zone
No, if you uploaded to the Blinded drop zone or if you uploaded to a study item and either the study does not allow unblinded documents or the document type cannot be unblinded
Blank, if you uploaded to a study item, and the study can contain unblinded documents, and the document type can be unblinded
Yes
Restricted
Always displayed
Yes, if the document type is restricted
No, if the document type is not restricted
No
Financial Interest Identified
Displayed only if the document type is configured to indicate that the document can contain financial interest information
Blank by default; select Yes or No to complete
Yes
IP Green Light
Displayed only if the document type is configured to indicate that the document can be relevant for a drug shipment
Blank by default; select Yes or No to complete
Yes
Note that your system may permit you to submit documents even if they do not have values in all required fields.
The Document Date,
Receipt Date, and Language fields can be made “sticky” to retain the value you
select and carry forward to other documents in the same review session. To use
the “sticky” feature, select the push pin icon next to the field. In the image
below, the push pin has been selected for the Receipt Date field.
You may want to delete a document from eUpload if the wrong content was uploaded, if the upload failed, or if the document was multi-indexed and must be processed from the eTMF (a warning is displayed in the right panel for the latter case).
To delete a document, click on the trash can icon in the left panel.
Note: If the document was multi-indexed, you must process the document in eTMF before deleting the document in eUpload. If you delete the document from eUpload before you have processed the document in eTMF, the document will be deleted from eTMF as well.
If multiple documents
are available on the left panel of the Review Files page, a Delete All button is displayed at the
bottom of the page. You can use this button to delete all listed documents from
both eUpload and from your eTMF Work Area (for example, if you uploaded the
wrong files).
The Content Viewer in eUpload displays the PDF rendition of the first page of the document selected on left panel, allowing you to quickly verify that the correct content was uploaded. If you want to view all pages of content, you can select one of the following options from the Actions menu:
View
Native Content – downloads the
file to your default download location in its original format, if not PDF (based
on browser settings)
View
PDF in Browser – opens the
document in a new browser tab or window
View
PDF in Acrobat – downloads the
PDF rendition of the document to your default download location (based on
browser settings)
If you are reviewing multiple documents, you can use the Sort feature to display the documents in the selected order. For example, you may want to review all documents with missing metadata first, so that you can complete indexing before submitting. In this situation, you can select “Metadata Status (Incomplete First)” from the sort menu. When sorting by metadata status, the system displays documents in the left panel in categorized lists, instead of in a single list. List categories include Missing Metadata, Metadata Complete, and Errors.
Documents listed under
the Metadata Complete category have values in all required fields. Only Outlook
.msg files can be listed under this category, as certain values are
automatically extracted from the files upon upload (for example, Document Date,
Language, etc.).
Note: Document Date and/or Receipt Date values may not be extracted from a .msg
file if the file did not originate in Outlook (for example, an email in yahoo
was sent to an Outlook account, downloaded from Outlook, and uploaded to
eUpload).
Documents listed under
the Missing Metadata do not have values in all required fields. You can choose
to enter values before submitting. Or, if your environment is configured to
allow submission of documents with incomplete metadata, you can submit these
documents without having values in all required fields.
You can choose to review a single uploaded document by selecting the Review File link for the document in the right panel or to review multiple documents by selecting the Review All link in the right panel.
Selecting the link takes you to the Review Files page, where you can view a PDF rendition of the first page of the available documents, complete missing metadata (if needed), and submit.
On the left of the
Review Files page, the document(s) available for review are displayed. If you
selected to review only one document on the previous page, this list will
contain only that document. If you selected to review all documents, the list
will contain all documents available for review (i.e., documents that have not
been deleted or submitted from eUpload). If the list displays multiple
documents, you can use the sort
options to display the documents in a logical order. For example, you may want
to display all documents with incomplete metadata first.
A shaded indicator
provides additional information about each document:
Green (check mark) – all required metadata fields have values (Note: Only Outlook .msg files uploaded can have this indicator, as the system extracts specific metadata directly from the file during the upload)
Yellow (!)- all required metadata fields do not
have values
Red (x) – document was not uploaded due to an
error
When you select a document with a green or yellow indicator, the first page of the document’s content is displayed in the middle panel, and the document’s metadata fields are displayed in the panel to the right. You can complete empty fields or change fields values as appropriate. Any values you specify are not saved unless you submit the document.
When you select a document with a red indicator, the specific error encountered during upload is displayed in the panel to the right. Because the upload failed, your only choice is to delete the document.
You can choose to
review and submit documents individually, or you can choose to submit all
documents at once without reviewing. When a document is submitted, any changes
to the metadata you’ve made in eUpload are saved, and the document is removed
from eUpload. In addition, the document’s status may update to either InQC or Final, based on the completeness of the metadata and the system’s
eUpload Workflow configuration.
Documents with
complete metadata can always be submitted. Once submitted, these documents will
either be sent to a QC task or automatically finalized, based on the
configuration of your system.
Documents with missing
metadata can be submitted only if your system is configured to allow the
submission of documents with incomplete metadata. If your system is configured
in this way, these documents will either be sent to an Indexing task or will
remain in your eTMF Work Area for further indexing.
During the upload, a panel on the right displays the progress of each document. When an upload has finished, an indicator shows whether or not the upload completed successfully, with warnings, or failed.
Note about uploading .msg
files: When uploading a .msg file, the system checks to see if the email is
part of an existing email thread in the study. If the system finds a match to
an existing email thread, the uploaded document will be automatically indexed
to that study item as a new version, even if that study item is associated with
a different document type and/or level than the one uploaded to.
Note: An error will occur if the document is not a supported file type or if it is password protected.
Documents in the right panel are listed in categories that generally correspond to the way you uploaded. Documents uploaded to the Blinded drop zone are always displayed in the Blinded category, and documents uploaded to the Unblinded drop zone are always displayed in the Unblinded category. Documents uploaded to existing study items are displayed in the Study Items category, if the study allows unblinded documents and the document type can be unblinded. Otherwise, they are displayed in the Blinded category.
Documents that are uploaded without errors will immediately
be available for review in eUpload and in the user’s eTMF Work Area.
Note about uploading .msg
files: When uploading a .msg file, the system checks to see if the email is
part of an existing email thread in the study. If the system finds a match to
an existing email thread, the uploaded document will be automatically indexed
to that study item as a new version, even if that study item is associated with
a different document type and/or level than the one uploaded to.
If existing, ad hoc (and eUpload-eligible) study items are associated with the breadcrumb level and reference model folder you selected, they are displayed below the drop zones. You can upload a document directly to one of these study items as another version.
If the list of study items is lengthy, you can use the Search and Sort features in the header to locate a specific study item.
To upload to a study item:
Select a document from your local file
explorer.
While
holding the mouse button, drag the document to the document icon until the icon
is outlined in green and the text “+Copy” is displayed.
Release
the mouse button. The system begins to upload the document.