eTMF Training Manual

for Sponsor and CRO

Version 8.0
Document Date: 02-Dec-2021

1
Contents
• Outline of eTMF
• eTMF Workflow
• EDL/Milestones
• Account Activation and Training (For Shionogi)
• Account Activation and Training (For CRO)
• Access Control, Electronic Records, Audit Trail
• Key Points for eTMF Operation

The detailed operation procedure is described in

“Vault eTMF Live Training for Sponsor and CRO”
- Upload, Edit, Delete, eSignature, Certified Copy etc.

2
Outline of eTMF

3
 What is eTMF

eTMF provides real-time inspection readiness, full

visibility into TMF status, and access for all study partners

Stay Inspection Ready

Ensure a constant state of inspection
readiness by managing all TMF
documents.

Streamline Collaboration
Give study teams a real-time view of
TMF completeness to help sponsors,
CROs, and sites work together to
accelerate trials.

4
 From Paper Document to Electronic Document

Before Paper Document Filing • eTMF is not just a file sharing

server.
• eTMF enables the quality control
by documentation process
recording the audit trail of all
activities (When, Who, What,
Where and How).

After Electronic Document Filing

5
eTMF Workflow

6
Concept of our eTMF
We can use many workflows for its use

Request & Submit

Drafted

Certified
Deleted Copy
Authoring
QC
Review Review
eSignature

Distribute
Approved

Periodic
Review

7
Implemented Workflow

8
 Filing Structure of eTMF
Study Product Mutual
MSA, CDA etc.

Study EDL Study EDL Study EDL

Zone Zone name

A Country B Country C Country
01 Trial Management
EDL EDL EDL

02 Central Trial Documents

03 Regulatory
Section
A Site EDL B Site EDL X Site EDL
04 IRB or IEC and other Approvals
01.01 Trial Oversight
05 Site Management
01.02 Trial Team Preparing Shionogi
06 IP and Trial Supplies Specific Classification
Artifact
01.03 ・・・
07 Safety Reporting
01.01.01 Trial Master File Plan
08 Central and Local Testing Classification(Sub Artifact)
01.01.02 ・・・
09 Third Parties 01.01.01 Trial Master File Plan
10 Data Management 01.01.01 Trial master file
specification
11 Statistics
01.01.01・・・・

9
EDL/Milestones

10
 Expected Documents and EDLs
• An Expected Document List (EDL), Expected Document Expected Document List
is a collection of Expected
Documents.
Expected Documents represent ED ED
•
documents that are expected in a
Protocol
Study’s TMF. ED ED
1 Required
• Each Expected Document aligns to
a single Document Type. ED ED

TMF Specification
Artf No. Document Classification Expected Document

01.01.01 Trial Master File Plan Trial Master File Plan

01.01.02 Trial Management Plan Project Management Plan

01.01.03 Quality Plan Quality Plan Vault eTMF (Study EDL)

11
 TMF Management by Milestones
There are 2
documents to store
to “01.01.01_Trial
2 Master File Plan” in
Start Start-Up Phase
Up

There are 2
documents to store
to “01.01.01_Trial
Status

Master File Plan” in

Con 4
Conduct Phase
duct

There is 1
document to store
to “01.01.01_Trial
5 Master File Plan” in
Close Close Out Phase
Out

Number of Expected Document will increase as Study status

12
Completeness Status
Completeness Status icon If your Completeness
# Final (Approved) Doc / # Expected Doc Status is Green, required
：≧100 % ：0*～99％ ：0% documents are stored in
*In case documents exist but not approved the Classification.

Tips!
Hover on the Completeness Status
icon (Green/Yellow/Red icon), you
can confirm the documents which
already uploaded like the figure on
the right.

13
Account Activation and Training
(For Shionogi users)

14
Invitation Email (1)
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Welcome to Veeva Vault!

• An invitation will be sent to you after

user registration is completed.
• After clicking the link, login page will
open (see next page).

15
Invitation Email (2)
• After clicking the button in (circled area), eTMF will open
without entering user credentials (ID and Password).

(Japanese) (English)

Note: Shionogi users can access eTMF without

entering user credentials by using SSO via Scinet /HPI.

16
 Acknowledgement to Training Material
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Acknowledge training material “Training Manual Name"

• Notification to acknowledge training

material will be sent together with the
invitation.
• Click the document name link to
access the document.

Note: You can access eTMF documents only after you acknowledge the
training material and your access right is set.
(Access right will be set within 2 days after the acknowledgement is
confirmed)

17
Acknowledgement to Training Material (1)

Note: By acknowledging the

distributed training material, you
are deemed trained, then access
right to the documents will be
set.

18
Acknowledgement to Training Material (2)
• For the first time you execute eSignature, Windows
popup blocker will be displayed on under Web browser.
• After this setting is executed , the popup blocker will not
be displayed for the next time.
(Japanese)

Click ‘このサイトのオプション’ and ‘常に許可’

(English)

Click ‘Options for this site’ and ‘Always allow’

19
Acknowledgement to Training Material (3)
At the timing of eSignature, a sign-in screen will appear
separately on the screen.
(Japanese) (English)

Enter your SCINET/HPI credentials.

• Upper : scinet\your ID(sxxxxx) / hpi\your ID
[View : scinet your ID(sxxxxx) / hpi your ID(sxxxxx)]
• Lower: Your Password for your ID

20
Account Activation and Training
(For CRO users)

21
Invitation Email
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Welcome to Veeva Vault!

• An invitation will be sent to you after

user registration is completed.
• Log in to eTMF using Username, Initial
password, and after your password has
been updated.

22
 Acknowledgement to Training Material
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Acknowledge training material “Training Manual Name"

• Notification to acknowledge training

material will be sent together with the
invitation.
• Click the document name link to
access the document.

Note: You can access eTMF documents only after you acknowledge the
training material and your access right will be set.
(Access right will be set within 2 days after the acknowledgement is
confirmed)

23
Acknowledgement to Training Material

After you have “read and

understood” the training
material, click “Received
& Reviewed”. Then,
select “I have read and
understood the training
material”. And enter your
credentials when
prompted.

Note: By acknowledging the

distributed training material, you
are deemed trained, then access
right to the documents will be
set.

24
Access Control, Electronic Records,
Audit Trail

25
User Role and Document Access Control
User’s Role Document Access
Affiliation (In
Assigned Role
(In Application Application Unblinded
Study Country Site
Form) Form) Documents

Editor Study Editor Yes Yes Yes No

Viewer Study Viewer Yes Yes Yes No

Sponsor Shionogi
Archive
Archive Viewer Yes Yes Yes No
Viewer
Unblinded
Study Editor
Record Yes Yes Yes Yes
RM Editor
Manager
Yes
Monitoring CRO CRO Editor No No (All of assigned No
Site)
Yes Yes
Study
CRO Editor (except for (except for Yes No
Monitoring CRO
09.02.03) 09.02.03)
Yes
(except for Yes
CRO Country N/A CRO Editor No 09.02.03 of (All of assigned No
Monitoring CRO
assigned Country Site)
Country)
Non-Monitoring
NA The documents assigned by a workflow No
CRO

Archiving CRO Study Editor Yes Yes Yes No

26
Documents Access Policy
• Sponsor Users, and Health Authority Inspectors
– Can access all documents.

• CRO Users (Clinical Operation)

– Can access all study site documents of the assigned sites.
– Can access the study/country documents if necessary.

• Non-monitoring CRO Users, Third Vendor Users (Lab, IRT, etc.)

– Can access the documents sent for authoring only.

• Site Users
– Can access the documents distributed or sent for authoring only.

Only unblinded users are provided access to blinded documents

(documents with unblinding content)

27
Unblinded Document Access Control
Unblinded Blinded Document Level
(Restricted) Content Content Controlled by Unblinded
(Metadata: (Metadata: Users by setting the
Unblinded=Yes) Unblinded=No) document metadata:
Unblinded=Yes

User Level
Controlled by TMFM
based on the User
Request Form
Unblinded Users Blinded Users

• In Vault eTMF, document metadata is automatically set to “Unblinded=No” when document is

uploaded. TMFM sets up placeholder and set to document metadata “Unblinded=Yes”. Unblinded
team must ensure to update document metadata to “Unblinded=Yes”, when uploading
documents with sensitive unblinding information.
• After final database is locked, unblinded RM releases the documents with unblinded (restricted)
content to be accessible to both blinded and unblinded users.
• Unblinded (Restricted) Content: contains sensitive study information (e.g. randomization) and
can only be viewed by a limited group of people to ensure that study team members do not know
which subjects are assigned to test groups versus placebo groups
• Blinded (Unrestricted) Content: can be viewed by all users without risk of biasing study results

28
 Electronic Records, Electronic Signatures
⚫ Code of Federal Regulations Title 21
PART 11 -- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart C--Electronic Signatures Sec. 11.300 Controls for identification codes/passwords.
Persons who use electronic signatures based upon use of identification codes in combination with passwords shall
employ controls to ensure their security and integrity. Such controls shall include: …

⚫ EudraLex The Rules Governing Medicinal Products in the

European Union
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
Annex 11: Computerised Systems

Operational Phase
12. Security

12.1 Physical and/or logical controls should be in place to restrict access to computerised system to authorised
persons. Suitable methods of preventing unauthorised entry to the system may include the use of keys, pass cards,
personal codes with passwords, biometrics, restricted access to computer equipment and data storage areas.

The reliability of audit trail and eSignature is assured

when user manages her/his user ID and password properly.

29
 Electronic Records, Electronic Signatures (Cont.)

⚫ Japanese ERES Guideline

– Using electromagnetic records and electronic signatures for
application for approval or licensing of drugs
4. Requirements for using electronic signatures
Persons who use electronic signatures shall meet following requirements to ensure the
reliability of electronic signatures.
(1) Employ procedures to manage and maintain of electronic signatures according to “Law on
Electronic Signatures and Certification Services” (Law No.102 of May 31, 2000), and practicing
them appropriately.
(2) Each electronic signature shall be unique to one individual and shall not be reused by,
or reassigned to, anyone else.
(3) Signed materials by electromagnetic records shall contain information associated with the
signing that clearly indicates all of the following:
- The printed name of the signer
- The date and time when the signature was executed
- The meaning (such as creation, confirmation or approval) associated with the signature.

The reliability of audit trail and eSignature is assured

when user manages her/his user ID and password properly.

30
Audit Trails
• After a user logins to the
eTMF system using her/his
Vault User Name and
password, all actions are
recorded as Audit Trail in
the eTMF system.
• In Audit Trail, all users
actions to documents are
recorded associated with
Timestamp and User Name.
• The Audit Trail records can
be confirmed in the Audit
Trail Report.

31
Management of User Name and Password
To assure the reliability of Electronic Records and
Electronic Signatures:

• Please do not reveal the combination of your

user name and password to others.

• Please do not leave from your computer in a

login state.

32
Key Points for eTMF Operation

33
 Creating and Uploading Documents
▪ Two Ways to Upload Documents into Vault
► Uploading via Expected Documents Op1
► Uploading via Create button Op2

▪ Recommended File Format for Upload → PDF

► Accepted formats: XLS, WORD, PPT, MSG
► Not Accepted format: SAS, XML

＊The detailed operation procedure is described in Vault eTMF Live Training for Sponsor and CRO. 34
 Document Naming Convention
Please refer to TMF Specs for Shionogi Document Name and
Dating Convention
▪ Auto-naming of Vault eTMF Document was implemented
▪ When uploading documents, Vault eTMF automatically name document according to metadata
(study, country, site, document name, Shionogi version number, document date) entered by the
uploader
▪ Trial: 1234R5678_Monitoring Plan_V1.0_20 Oct 2020
▪ Country: 1234R5678_USA_Monitoring Plan_V1.0 _20 Oct 2020
▪ Site: 1234R5678_USA_160_Monitoring Plan_V1.0 _20 Oct 2020

▪ Please Edit the Document Name and Version number as necessary

▪ Note:
▪ If the automatically added document name is not suitable, please correct the document name to proper
one
▪ If the “Shionogi version number” field is displayed in yellow, version number is a required metadata field.
If no version number, please enter dummy number at first and then remove it from the document name
after uploading document
▪ Document Date (if necessary, Expiration date) is a required metadata field. Please refer to Dating
Convention in TMF Specs to enter this date. Once entered, it will automatically added to the Document
Name after clicking Save
▪ If no document date apparent on the document, please enter "01Jan1900" as dummy data

＊The detailed operation procedure is described in Vault eTMF Live Training for Sponsor and CRO. 35
 eSignature
▪ In lieu of wet-ink signature, document may be signed
electronically in Vault eTMF
▪ If there is a Signature Page on document, please write: <Refer to
eSignature Flag> on the signature line, prior to uploading into
Vault eTMF
▪ When providing eSignature, the user need to enter User Name
and Password after selecting a Role
▪ The record of eSignature can be confirmed from the Rendition
and Audit Trail.

＊The detailed operation procedure is described in Vault eTMF Live Training for Sponsor and CRO. 36
 Certified Copy
• The PDF file scanned from original paper document is
just Electronic Copy, not Certified Copy.
Paper
Doc PDF
Certified Copy meets the following points
• The PDF file scanned from original paper document.
• The PDF file assessed that it is a true copy of the paper document.
• The Certified Copy assessment result is recorded.

• At the completion of the Certified Copy assessment and

record of the result, the scanned PDF file becomes a
Certified Copy of the paper document (equivalent to
original paper document).
Paper Certificates
Doc PDF （Result of Assessment）

Certified Copy

＊The detailed operation procedure is described in Vault eTMF Live Training for Sponsor and CRO. 37
 Certified Copy – Workflow -
After Certified Copy is created, original
1 paper can be discarded.（Contracts should
Original Document not be discarded due to legal problems）

Paper Paper 5
Paper
Doc Doc

Certified Copy
personnel
PDF
4
Generator Assess image quality on eTMF
2 Create PDF file The same in accordance with the check items
person can be
by scanning appointed Record the result of assessment on
eTMF

PDF
PDF Certified
Uploader
PDF Copy
3 Upload PDF file
to eTMF eTMF

＊The detailed operation procedure is described in Vault eTMF Live Training for Sponsor and CRO. 38
 Certified Copy - Important Check Points -
Conditions for Creating PDF:
• Resolution
– Recommend over 300 dpi
> Consider the balance between legibility and file size
• Color
– The document of Bi-tonal(White/Black): Bi-tonal
– The coloured document: color (If color is not important information, it
may be copies as bi-tonal.)

Check Items for Certified Copy:

• Presence
– Everything in original paper document is present in the electronic PDF
image
• Legibility
– All content, signatures and images are legible
• Other information
– There is no additional specific information added that is not part of the
original document

＊The detailed operation procedure is described in Vault eTMF Live Training for Sponsor and CRO. 39
Notes: Useful material
Vault eTMF Live Training for Sponsor and CRO

40
Vault eTMF Live Training for Sponsor and CRO

The detailed operation procedure is described in

Vault eTMF Live Training for Sponsor and CRO

Please see the following link

Veeva Vault - Vault eTMF Live Training for Sponsor and CRO
(including EDL operation)_V2.0_02Dec2021

41
End of File