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ETMF Training Manual For Sponsor and CRO V8.0
ETMF Training Manual For Sponsor and CRO V8.0
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
2
Outline of eTMF
3
What is eTMF
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
5
eTMF Workflow
6
Concept of our eTMF
We can use many workflows for its use
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.
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
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
There is 1
document to store
to “01.01.01_Trial
5 Master File Plan” in
Close Close Out Phase
Out
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!
15
Invitation Email (2)
• After clicking the button in (circled area), eTMF will open
without entering user credentials (ID and Password).
(Japanese) (English)
16
Acknowledgement to Training Material
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Acknowledge training material “Training Manual Name"
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)
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)
(English)
19
Acknowledgement to Training Material (3)
At the timing of eSignature, a sign-in screen will appear
separately on the screen.
(Japanese) (English)
20
Account Activation and Training
(For CRO users)
21
Invitation Email
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Welcome to Veeva Vault!
22
Acknowledgement to Training Material
From: vault-emails@veeva.com
Subject: [Shionogi eTMF] Acknowledge training material “Training Manual Name"
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
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
26
Documents Access Policy
• Sponsor Users, and Health Authority Inspectors
– Can access all documents.
• Site Users
– Can access the documents distributed or sent for authoring only.
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
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: …
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.
29
Electronic Records, Electronic Signatures (Cont.)
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:
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
*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
*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.
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.)
*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
41
End of File