Version 3, 15 Sep 2018

Document Owner: Sharon Stothard

Email to eTMF Interface
Storing Pertinent Correspondence in eTMF
This Reference Guide will cover:
• What the email to eTMF interface does
• The Prerequisites for using the email to eTMF interface
• Determine when Pertinent Correspondence should be used with the
email to eTMF interface
• How to use the email to eTMF interface

What is the email to eTMF interface?

The interface allows eTMF users to forward TMF relevant correspondence from their
email inbox to the eTMF directly for indexing.

The interface will process and render the email (including attachments), and the
document will show up in the Finalized Indexing widget in the eTMF.

Once the document is visible, index your email in eTMF as you do now for any
document that you upload to the system. If your email had attachments, they will
remain associated to your document as a “related document” in the eTMF and can be
seen in the multi-tracking tab.

The Business Needs

The email to eTMF interface meets the following business needs:
• Addresses Audit Findings – Following MHRA findings in 2016 where
pertinent correspondence was missing from the TMF. The interface will
simplify the upload process for all users and support the upload of
correspondence in a timely manner
• Improves user experience by using functionalities of systems a user is familiar
with, such as email and eTMF
• Support Data Quality – The speed which with users can now upload and index
pertinent correspondence will support study data quality

Version 3, 15 Sep 2018

Document Owner: Sharon Stothard
Prerequisites to using interface
In order for users to utilise the email to eTMF interface users will need to have:
• Completed TMF Process Training
• Completed relevant training for eTMF Study Leader, Document Uploader or
Business Admin access
• Been granted access to eTMF which allows them to upload and index
documentation

Users with Read-Only access will not be able to use this tool

Identifying Pertinent Correspondence

As with all parts of the TMF, it is important that only TMF correct and relevant
information is archived in the eTMF.

Not all study correspondence is considered pertinent. Only pertinent

correspondence should be forwarded to eTMF for archiving. Filing
documents which are not pertinent will impact compliance and
delay the filing process.

The Business Rules

There are two different scenarios in which the interface should be used:

1. The content of the email is recognised as TMF relevant information and

therefore should be uploaded into the corresponding placeholder.

2. An email attachment is relevant TMF information. However, there is no

corresponding placeholder.

Below are examples of when not and when to use the interface according to these
scenarios.

Practical Examples
1. Email is the TMF Relevant Document
If the email is the actual TMF relevant document, use the interface and index
the document in the corresponding placeholder. For example, if a CRA sends:
 A follow-up letter as an email, the interface can be used to upload
and file it in a Follow Up Letter placeholder

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  A submission to an IRB as an email, the interface can be used to
upload and file it in the IRB-IEC Submission placeholder
 A communication as an email and if is considered TMF Relevant
Correspondence, the interface can be used to file it in the TMF
Relevant Correspondence placeholder

2. Email was used to send TMF Relevant Document

If the TMF relevant email is used to send/share a document, the interface can
ONLY be used if the document attached is TMF Relevant which doesn't have
its own placeholder in the eTMF (i.e. protocol, newsletter, etc).
For example, if an author/document owner sends or receives:
 A Word/PDF communication and is sent to a site by email, the
interface can be used
 A memo and it is sent by email to Investigators or Site Staff with a
TMF relevant instruction, the interface can be used

If an email attachment is recognised as TMF relevant information

which has an existing placeholder, the document should be
downloaded and uploaded directly into the eTMF and indexed
accordingly. For example: A 1572/Financial Disclosure Form/ Green
Light Form (or any other TMF document that has a specific
placeholder)

3. Other common examples are described below, would you send these
documents to the eTMF via the interface?

Situation
a. Documents sent to sites, for
example a Lab Manual, i.e. a
CRA/CSM sends an email to
the site informing them about
a new Lab Manual.
b. IRB approval with
attachments, i.e. a site
forwards an approval email
along with the approved ICF
as an attachment.
c. Correspondence to site with
documents attached that
don’t have a specific
placeholder (i.e.) A
CRA/CSM needs to send an
email containing a
spreadsheet of overdue
queries to be resolved.
Action
In this case as the Lab Manual has its own placeholder, the
author/document owner needs to forward the email to the
interface address without the attachment. The
author/document owner also needs to ensure that a
description of the attached document is included in the
email body/letter, for example:
‘WO39210 Covance Lab Manual V3 dated 26 June 2018’
Since the approved ICF has its own placeholder therefore
it must be deleted from the email and the ICF must be
uploaded in the usual way. Once the attachment has been
deleted the IRB approval can be forwarded to the email to
eTMF interface
This can be forwarded as is with the attachment to the
interface. Please keep in mind that the printing area of the
spreadsheet needs to be set-up properly to prevent any
content loss during rendering. Ensure to do this before
sending the email to the site and to the interface

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Technical considerations
The following ‘technical’ perquisites for the interface to work successfully and
prevent rejections and/or QC issues, review the following table.

Topic Guidance
1. Forward Email to The email MUST be forwarded to global.etmfimport@roche.com (i.e. do
not use cc or bcc) and do NOT include other email addresses in the ‘To’
field.
2. Avoid/remove The email Subject Line must NOT start with “RE” – the email will be
Subject ‘RE’ rejected as only final correspondence should be archived in the eTMF, if
necessary delete this text.
3. Manage a. Delete attachments that are not pertinent, they cannot be deleted once
Attachments the email has been sent to the eTMF.
b. The format must be supported by the eTMF, for instance video files,
audio files, web pages, and JPEG cannot be rendered by the eTMF.
c. “.JPEG” file extensions can be changed to “.JPG” for it to be rendered.
d. Excel documents should have the print area defined to focus the
rendering to the correct area of the file and prevent data loss.
e. ZIP files can be sent, but check all content is supported files, delete
files that are not pertinent, &/or remove & upload RRM files to eTMF
4. Manage Links for a. A URL in an email will only work while the content is still available at
web pages and this address; this is typically for a much shorter timeline than data
Google Docs retention archival requirements.
b. When a Google Documents or other web page is included in the email,
and the information is part of the pertinent correspondence, the web
document/page needs to be saved as a PDF file and attached to the
email before forwarding.
c. Web pages that are multiple pages can sometimes be saved to a single
MHTML file, but this format cannot currently be rendered by the
eTMF.
5. Wait before Emails are processed hourly by the interface, so wait a while before going
indexing to index.
6. View attachments To view the attachments on the Finalize Indexing tab click on the blue tab at
while Indexing the bottom and drag it upwards to view the Attachments Widget.

Step by step instruction to prepare an email & attachments are on the next page.

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 How-To Use the email to eTMF Interface

1. Determine if the previously sent email & its attachments are pertinent
(belongs in eTMF) 5. Forward the email to global.etmfimport@roche.com
2. Select ‘Forward’ in the mailbox and enter 6. eTMF will render the email which will appear in the
global.etmfimport@roche.com in the ‘To:’ field. indexing widget
3. Ensure that the file extensions will be accepted by eTMF (see
technical considerations #3)

4. Manage attachments & URL (Skip to step 5 if not applicable)

7. Index the email as per the normal eTMF indexing processes,

ensure the document date is correct (i.e. the final email date),
and add comments to help others find the document.
a. Click on the ‘x’ of the attachment to remove it if not pertinent

b. Open any zipped folders and remove any non-pertinent files

documents, press Ctrl + S ensures this change is saved

c. Save web pages / Google Docs to PDF files and attach them if
pertinent

Version 3, 15 Sep 2018

Document Owner: Sharon Stothard
Version 3, 15 Sep 2018
Document Owner: Sharon Stothard