EDC Management Sheet: Precautions for Sheet Completion Ver.1.

00
海外とのコミュニケーションのために日本製薬工業協会にて自主的に翻訳したものであり、翻訳内容については責任を負えないことを予めご了承ください。

訳注1：電磁的記録はe-文書法の英訳に従い、"electromagnetic records"としています。なお、e-文書法 2章の4の電磁的記録の定義は次のとおりです。

Electromagnetic records are records that are produced in an electronic form, electromagnetic form, or some other form that cannot be recognized through human
perception, and shall refer to those that are made available for use in information processing by an electronic computer.

訳注2：GCPの運用通知については、対応するICH-GCPを引用しております。そのため、PMDAのシートにはないICH-GCPについても記載しております。

1. Basic concept, composition, etc. of EDC management sheet

(1
In this sheet, "Clinical trials, etc." means "clinical trials, post-marketing clinical trials, and use-results surveys".
)
(2
Since this sheet template may be updated for the improvement of convenience, keep the template version number in mind when completing.
)

Regarding clinical trials, etc. using EDC, record the summary of the procedures for assuring the quality of data etc.
(3 In using electronic record, since appropriate system selection, appropriate allocation of authority of entry and modification to users, appropriate use by the
) authorized users, etc. are important to prevent falsification or loss of data, specifically record the means and procedures for assuring the quality of data
etc.

Though this sheet is introduced as a material to be reviewed in compliance inspections by PMDA, it is also assumed that the sponsors/marketing
(4
authorization holders (MAH) etc. Use it as a self-checking tool by recording the information on ongoing clinical studies etc., and updating and maintaining
) as needed after the completion of compliance inspections or in changing the systems/procedures, etc.

(5 In this sheet, start recording from clinical trials, etc. included in the application package to be inspected in the first compliance inspection using this sheet.
) For compliance inspections for the second time and later, do not delete the contents of the sheet submitted previously, but add only the items changed.

Create "Operational Procedure Sheet" for each EDC system.

When multiple systems have ever been used, record by adding "Operational Procedure Sheet" by the number of systems used.
(6
They can be created as separate sheets if the operation differs even in the same system.
) Regarding the "Operating Experience Sheet", there must be a single sheet to be maintained even if the multiple systems are utilized.

(7 "Operational Procedure Sheet" and "Operating Experience Sheet" can be maintained in separate files. In such a case, they can be submitted as separate
) files without integrating them for the inspections.

It is possible to modify the format and use it according to type of management in the sponsors/MAHs etc.
(8 ・ If you want to maintain the sheet by MS-Word, create MS-Word version of the Management sheet in your company and use it.
) ・ Each item in the sheet is the minimum to be confirmed. Regarding the items, it is possible to add items appropriately based on the actual management
conditions, but it is required to deal with them properly while holding necessary information.

Submit this sheet in processable file format.

The file name is to be "EDCMS_<sponsor/MAH etc. name>_<number of intended purpose (01:Case report form (CRF) used in clinical trial, 02:Patient
Diary, 03:CRF used in post-marketing surveillance, 04:Others)_documentation date(yyyymmdd)" (alpha-numeric codes are to be one-byte characters.
(9 Sponsor/MAH etc. name can be English name.).
) Example of file name) EDCMS_○△Pharmaceutical_01_20130327
In case "Operational Procedure Sheet" and "Operating Experience Sheet" are submitted in separate files, "Operational Procedure Sheet" and "Operating
Experience Sheet" should be respectively identified after the number of intended purpose of each file name.
Example of file name) EDCMS_○△Pharmaceutical_01_Operational Procedure Sheet_20130327

2. Completion of Operational Procedure Sheet

Specifically record the information common to the system according to each item in the sheet.
(1 Specifically record the summary of the procedure and resulting documents so that people other than the reporter can understand the contents of the
) written procedures.
Based on the actual condition of each sponsor/MAH etc., it can be organized by adding attachment appropriately.

(2 When the same procedures have ever been used in multiple clinical trials, etc., provide the information common to the system.
) Regarding the individual written procedures to each clinical trials, etc., record them in "Operating Experience Sheet" by each clinical trials, etc.

(3 If there are changes, etc. in the sheet items including the revision of the documented procedures, do not delete the contents before changes, but add the
) updates by inserting a column to the right in sequence.

(4
If there are multiple written procedures to be recorded, add rows appropriately and use them.
)

Regarding the events to be recorded in the section of 6. "(Critical) system faults occurred and incompliance with the procedure during the trial," "Matters
pointed out in previous inspections," and improvements made, The sponsor/MAH etc. is to judge based on the items pointed out in the previous
(5
inspections and the items to which the company offered improvement as a response to the inquiries.
) Occurrences of the situation where data entry couldn't be reflected correctly (lack of data or audit trail, data collection errors occurred due to error in setup
of individual clinical trials, etc.), improper use of user ID etc which affected on the blindness, safety of the subjects/patients, and so on are included.

3. Completion of Operating Experience Sheet

Specifically record for each clinical trial, etc. according to each item in the sheet.
Specifically record the summary of the procedure and resulting document, so that people other than the reporter can understand the contents of the
written procedures.
(1
Based on the actual condition of the sponsor/MAH etc., it can be organized by adding attachment appropriately.
) (If the information (the summary of the procedure and resulting document etc) are recorded in Operational Procedure sheet, only document numbers and
document names of the written procedure should be recorded.)

(2 Describe individual resulting contracts, written procedures, etc. for each clinical trial.
) When the same procedures are used in multiple trials in this system, describe the information common to the system in "Operational Procedure Sheet."

In this sheet, record not only the information of clinical trials, etc. included in the application package subject to the compliance inspection (including
(3
clinical trials, etc. performed abroad) but also that of clinical trials, etc. (clinical trials, etc. in Japan local and global clinical trials including Japan) which
) was ongoing or started with this EDC system after the first compliance inspection using this sheet.

(4 In the column "In-scope of this time of inspection?", check either "Yes" or "No" according to whether or not clinical trials, etc. listed are subject to the
) compliance inspection when this sheet is submitted.
 1
EDC Management Sheet (for Sponsor/Marketing Authorization Holder ※Ver1.00
(MAH)) Operational Procedure Sheet (JPMA Translation)

2
Name of the sponsor or the
MAH
3
※In this sheet, "Clinical trials, etc." means "clinical trials, post-marketing clinical trials, and use-results
surveys".
4 1. System overview
5

6 Name of the EDC System Viedoc

X ASP (Application Service Provider) service (Company name: )

System category (System development type)
7 £ In-house development
£ Other ( 　)

X 01 Case report form (CRF) used in clinical trial

X 02 Patient diary
8 Intended purpose (Collected information etc)
X 03 CRF used in Post-marketing surveillance
£ 04 Other ( )

X ASP service security policy/procedure is used

9 Security measures for the overall system £ Internal security policy/procedure is used
£ Other ( 　)
10
11
12 Entry column　
13 [1] [2] [3] [4]
Version of the EDC system
14 (Only major upgrades such as adding functions to be Viedoc 4.28 Viedoc 4.29 Viedoc 4.30 Viedoc 4.31
specified)
Duration of use
15 2016-08-25 - 2016-10-10 2016-10-10 - 2016-11-17 2016-11-17 - 2016-12-12 2016-12-12 - 2017-01-29
(20xx/xx/xx ~ 20xx/xx/xx)
Release declaration
16 8/25/2016 10/10/2016 11/17/2016 12/12/2016
(20xx/xx/xx)

The new functionalities in this The new functionalities in this

release are:
Differences from the previous version
Medical coding: additional
* Briefly summarize the release notes of the version
17 dictionary support (WHO DD
obtained internally or from a vendor. Can be left blank in
and IDF)
case of a newly introduced system.
Export in CDISC ODM format
API extended with method:
GetClinicalData
release are:
The new functionalities in this
release are: The new functionality in this
Automatic creation of groups
release is:
of sites
Dynamic randomization
Support for entry of a
Support for unscheduled and Support for data import
reference ID that serves as a
common events in ViedocMe
license key for the study

Status of conduct or confirmation of the computer

system validation at the time of system introduction or Release certificate attesting Release certificate attesting Release certificate attesting Release certificate attesting
18 system update to full validation available to full validation available to full validation available to full validation available
from http://viedoc.com from http://viedoc.com from http://viedoc.com from http://viedoc.com

Version of the EDC system

19 (Only major upgrades such as adding functions to be Viedoc 4.32 Viedoc 4.33 Viedoc 4.34 Viedoc 4.35
specified)
Duration of use
20 2017-01-09 - 2017-03-02 2017-03-02 - 2017-04-20 2017-04-20 - 2017-06-01 2017-06-01 - 2017-08-24
(20xx/xx/xx ~ 20xx/xx/xx)
Release declaration
21 1/29/2017 3/2/2017 4/20/2017 6/1/2017
(20xx/xx/xx)

The new functionalities in this release

The new functionalities in this release
are:
Support for export of queries, data
Differences from the previous version
review status and medical coding to
* Briefly summarize the release notes of the version
22 CDISC ODM format.
obtained internally or from a vendor. Can be left blank in
case of a newly introduced system.
Support for fetching queries, data review
status and medical coding in CDISC
ODM format through the API.
The new functionalities in this release are:
Support for a VAS scale in ViedocMe
Support for additional data types in ViedocMe
Configurable password expiration time in
Viedoc
are:
Print study workflow in Viedoc Designer.
The new functionality in this release is:
New export format for Excel and CSV
Support for file upload. outputs, as one row per item, with the
possibility to include the full history of
CRF data as well.
File upload in ViedocMe.

Status of conduct or confirmation of the computer

system validation at the time of system introduction or Release certificate attesting to full Release certificate attesting to full Release certificate attesting to full
Release certificate attesting to full validation
23 system update validation available from validation available from validation available from
available from http://viedoc.com
http://viedoc.com http://viedoc.com http://viedoc.com

Version of the EDC system

24 (Only major upgrades such as adding functions to be Viedoc 4.36 Viedoc 4.37
specified)
Duration of use
25 2017-08-24 - 2017-10-09 2017-10-09 -
(20xx/xx/xx ~ 20xx/xx/xx)
Release declaration
26 8/24/2017 10/9/2017
(20xx/xx/xx)

Differences from the previous version
* Briefly summarize the release notes of the version
27
obtained internally or from a vendor. Can be left blank in
case of a newly introduced system.
Status of conduct or confirmation of the computer
system validation at the time of system introduction or
28 system update
19
20 2. Outsourcing contract (Construction/operation of the EDC System, operation of Help Desk, etc.)
21
22
23 Name of vendor/contracted resource (1)
24 Scope of outsourced services
Date/period of Contract, etc.
25
26
27 Name of vendor/contracted resource (2)
28 Scope of outsourced services
Date/period of Contract, etc.
29
30
3. Requirements for the Use of Electromagnetic Records
31 (Translation memo: ER/ES guideline is "Guideline for using Electromagnetic Records and Electronic Signatures in
Submission for Approvals, Licenses, etc., of medicinal and Other Products".)
32 ER/ES Guideline 3.1. :
33 Regulatory requirements
ER/ES Guideline 3.1.
The reliability of the system using
electromagnetic records has
been ensured by computerized
system validation.
GCP application notification
Item 3 (1), Paragraph 1 of Article
26
Procedure of testing trial-
34
ICH GCP 5.5.3 specific setup
a) Ensure and document that the
electronic data processing
system(s) conforms to the
sponsors established
requirements for completeness,
accuracy, reliability, and
consistent intended performance
(i.e. validation).
35
The new/updated functionalities in this release
are:
• Alerts and trackers.
The new functionalities in this release
• Medical coding – improved search options.
are:
• Medical coding – display active ingredients in
WHO DD dictionary.
Reference data - makes it easy to enter
• Medical coding – preferred and drug name
data shared by many subjects. It is
are included in the export for WHO DD.
possible to have centralized reference
• In Viedoc Clinic, if a subject is being edited
data for different data sources (the
by another user, this is marked on the subject
provider of the reference data values,
card with the username and user ID of the user
such as a lab), that makes it possible to
who is editing the subject.
fill in only once the reference values and
• Option to prevent future dates in Date item.
these will be automatically populated to
• Option to include/exclude the subject initiated
the subject forms, instead of having to
events in Viedoc Clinic.
open each subject form to enter the
• System checks are included in the Outputs
same reference values repeatedly.
and validation summary in Viedoc Designer.
• New options for the VAS Scale item so that it
Range item - A new item type is
can be configured for the EQ5D questionnaire.
available to be added to forms, for
• Max file size for the file upload is now 512
defining a range of values.
MB.
Non-functional updates:
• Medical coding – updated disclaimer.
Release certificate attesting to full
Release certificate attesting to full validation
validation available from
available from http://viedoc.com
http://viedoc.com
Entry column　
*If there is an individual agreement in line with a comprehensive agreement, specify the comprehensive agreement in this column and the individual agreement in the
"Operating Experience Sheet."
*If some operation was outsourced, note that the contract based on Ordinance of the Ministry GCP Article 12 or Ordinance of the Ministry GPSP Article 10 is required.
Contract date: Contract date: Contract date: Contract date:
Contract period (from): Contract period (from): Contract period (from): Contract period (from):
Contract period (until): Contract period (until): Contract period (until): Contract period (until):
Automatic contract renewal £No　£Yes Automatic contract renewal £No　£Yes Automatic contract renewal £No　£Yes Automatic contract renewal £No　£Yes
Contract date: Contract date: Contract date: Contract date:
Contract period (from): Contract period (from): Contract period (from): Contract period (from):
Contract period (until): Contract period (until): Contract period (until): Contract period (until):
Automatic contract renewal £No　£Yes Automatic contract renewal £No　£Yes Automatic contract renewal £No　£Yes Automatic contract renewal £No　£Yes
Management
The following requirements described below should be established in the system using electromagnetic records and in the operational procedures
Methods of
for the system. It should be supposed that the reliability of the system using electromagnetic records has been ensured by computerized system
Electromagnetic
validation.
Records
Entry column
* Specify in "1. System overview" the outline of results of the computer system validation at the time of system introduction and system update.
Management Method
*For testing trial-specific setup (UAT, etc.), specify it in this column.
Written procedure of testing trial-specific
setup
Document number:
Document title:
Version:
Effective date:
Differences from previous version:
Summary of the procedure and resulting Available in the online documentation for
documents: Viedoc Designer, chapters entitled "Outputs
and Validation" and "Validate a design".
Version handled together with the rest of the
online documentation, present version is
1.0.261.0
 Authenticity of Electromagnetic records should have integrity, accuracy and reliability, and the responsibility for their creation, modification, and deletion should
36 ER/ES Guideline 3.1.1. Electromagnetic be clear.
Records In order to ensure their authenticity, the following requirements should be met;

37 Regulatory requirements Management Method Entry column

Encryption of the communication

between the terminal and server
38 T SSL (Secure Socket Layer)
£ VPN (Virtual Private Network)
£ Other ( )
Measures for maintaining
security
Personal authentication
T ID/password
£ One-time password
39
£ Biometrics authentication (fingerprint,
retina, vein)
£ Other ( )

Policy / Guidance for maintaining

security
Document number: COMDOC05
Document title: Information Security
Policy
Version: 3
Effective date: 2011-10-31
Differences from previous version: New
document template
40
Summary of the procedure and resulting
documents: Contains procedures
addressing the following:
- Access to Information
- Business Aspects
- Accountability
- Systems
- Customer Contracts
- Incidents and Deviation Handling

Written procedures of requesting user

registration, granting ID/password,
reviewing users, removing the registered
users Available in the online documentation for
Document number: Viedoc Admin, chapter entitled "Handle users".
ER/ES Guideline 3.1.1.
41 Document title: Version handled together with the rest of the
(1) Rules and procedures for
Version: online documentation, present version is
maintaining securities of the
Effective date: 1.0.261.0
system are documented and
Differences from previous version:
adequately implemented.
Summary of the procedure and resulting
documents
GCP application notification
Procedures for
Item 3, Paragraph 1 of Article 26
maintaining of security Written procedures for users how to use
ICH GCP 5.5.3 the ID/password
d) Maintain a security system that Document number: Available in the online documentation for
prevents unauthorized access to Document title: Viedoc Clinic, chapter entitled "Introduction".
42 the data. Version: Version handled together with the rest of the
e) Maintain a list of the Effective date: online documentation, present version is
individuals who are authorized to Differences from previous version: 1.0.261.0
make data changes (see 4.1.5 Summary of the procedure and resulting
and 4.9.3). documents:

Written procedures for users how to train

users
Document number: The online documentation for Viedoc includes
Document title: step-by-step written procedures, video tutorials
43 Version: and answers to frequently asked questions. The
Effective date: present version of the online documentation is
Differences from previous version: 1.0.261.0
Summary of the procedure and resulting
documents

Other
Document number:
Document title:
Version:
44
Effective date:
Differences from previous version:
Summary of the procedure and resulting
documents

List of persons authorized to access the

system
Trial being conducted:
£ Managed by means of hard copies
T Managed by means of the system
£ Managed by means of
List of persons
electromagnetic records other than this
authorized to access the
system
system (i.e. list of
45
persons authorized to
Upon completion of the trial (to be
create and modify the
submitted at the time of inspection)
data)
£ Managed by means of hard copies
£ Managed by means of the system
£ Managed by means of
electromagnetic records other than this
system

46 Throughout the conduct of the Clinical Trial etc.

T Possible £ Not possible : Does the
system have full audit trail capability?
T Possible £ Not possible : To clearly
identify the initial data entry by user ID
(account holder)
T Possible £ Not possible : To clearly
identify which data was is automatically
calculated/derived
T Possible £Not possible : To clearly
determine data loaded (through a
system-to-system account or individual
user account)
T Possible £ Not possible : To clearly
identify the data modifications by user ID
Outline of audit trails with (account holder)
regards to creation / T Possible £Not possible : To retain
47
modification of retained (i.e. not to delete) information prior to
information modification
T Possible £ Not possible : To view
full audit history trails (sponsor)
T Possible £ Not possible : To view
full audit history trails (medical institution)

* For item of "Not possible," specify the

situation.

* Explanation about presentment (how

and what information surfaces)
All data displayed in the form of an audit
trail that can be downloaded from the
system.

Written procedure for modifying

information retained in the EDC System
Available in the online documentation for
Document number:
Viedoc Clinic, chapter entitled "Reset and
Document title:
delete".
48 Version:
Version handled together with the rest of the
Effective date:
online documentation, present version is
Differences from previous version:
1.0.261.0
Summary of the procedure and resulting
ER/ES Guideline 3.1.1.
Written procedure for documents:
(2) Creators of the retained
securing the authenticity
information are clearly identified.
of retained information
In addition, whenever the
retained information is modified,
the information prior to the
modification is maintained, and
the modifier is also clearly
identified. Furthermore, it is
desirable that audit trails are
automatically recorded and any
recorded audit trails are verifiable
by predetermined procedures.
 ER/ES Guideline 3.1.1.
Written procedure for
(2) Creators of the retained
securing the authenticity
information are clearly identified.
of retained information
In addition, whenever the Written procedure for viewing the audit
retained information is modified, trails
Available in the online documentation for
the information prior to the Document number:
Viedoc Clinic, chapter entitled "Data entry,
modification is maintained, and Document title:
edits, queries".
49 the modifier is also clearly Version:
identified. Furthermore, it is Version handled together with the rest of the
Effective date:
desirable that audit trails are online documentation, present version is
Differences from previous version:
automatically recorded and any 1.0.261.0
Summary of the procedure and resulting
recorded audit trails are verifiable documents:
by predetermined procedures.
50 Post completion of the Clinical Trial etc.
GCP application notification
Item 3, Paragraph 1 of Article 26 T Possible £ Not possible : Does the
system have full audit trail capability?
ICH GCP 5.5.3 T Possible £ Not possible : To clearly
c) Ensure that the systems are identify the initial data entry by user ID
designed to permit data changes (account holder)
in such a way that the data T Possible £ Not possible : To clearly
changes are documented and identify which data was is automatically
that there is no deletion of calculated/derived
entered data (i.e. maintain an T Possible £Not possible : To clearly
audit trail, data trail, edit trail). determine data loaded (through a
system-to-system account or individual
user account)
T Possible £ Not possible : To clearly
identify the data modifications by user ID
Outline of audit trails with (account holder)
regards to creation / T Possible £Not possible : To retain
51
modification of retained (i.e. not to delete) information prior to
information modification
T Possible £ Not possible : To view
full audit history trails (sponsor)
T Possible £ Not possible : To view
full audit history trails (medical institution)

* For item of "Not possible," specify the

situation.

* Explanation about presentment (how

and what information surfaces)
All data displayed in the form of an audit
trail that can be downloaded from the
system.

Written procedure for modifying

information retained in the EDC System
Available in the online documentation for
Document number:
Viedoc Clinic, chapter entitled "Reset and
Document title:
delete".
52 Version:
Version handled together with the rest of the
Effective date:
online documentation, present version is
Differences from previous version:
1.0.261.0
Summary of the procedure and resulting
Written procedure for documents:
securing the authenticity
of retained information
Written procedure for viewing the audit
trails
Available in the online documentation for
Document number:
Viedoc Clinic, chapter entitled "Data entry,
Document title:
edits, queries".
53 Version:
Version handled together with the rest of the
Effective date:
online documentation, present version is
Differences from previous version:
1.0.261.0
Summary of the procedure and resulting
documents:
54
55 ER/ES Guideline 3.1.1.
(3) Backup procedures for the
electromagnetic records are
documented and adequately
implemented.
GCP application notification
56
Item 3, Paragraph 1 of Article 26
ICH GCP 5.5.3
f) Maintain adequate backup of
the data.
57
58
59 ER/ES Guideline 3.1.2.
60 Regulatory requirements
61
62
ER/ES Guideline 3.1.2.
The contents of electromagnetic
records should be provided as
human readable format (output to
63 display, output to paper and copy
to electromagnetic recording
media).
64
65
66 ER/ES Guideline 3.1.3.
67 Regulatory requirements
68
69
ER/ES Guideline 3.1.3.
(1) Procedures for ensuring their
storability, such as maintaining
electromagnetic magnetic
recording media, are
documented and adequately
implemented.
(2) When electromagnetic
records that have been retained stability during the
are migrated to other
electromagnetic recording media
or formats, the authenticity,
readability, and storage stability
of the migrated electromagnetic
70
records are ensured.
71
72 4. Requirements for the Use of Electronic Signatures
73 ER/ES Guideline 4.
74 Use of electronic signature yes/ no
75 Regulatory requirements
76
ER/ES Guideline 4.
(1) Procedures for management
and operation for electronic
signatures are documented and
adequately implemented in
accordance with the Law
Concerning Electronic Signatures
and Certification Services (Law
No. 102, dated 31 May 2000).
(2) Each electronic signature is
unique so as to identify each
individual, and not be reused by
or reassigned to anyone else.
(3) When electronic signatures
are executed to documents using
electromagnetic records, the
signed electromagnetic records
include information that indicates
Throughout the conduct of the Clinical Trial etc.
Written procedure for management of
data backup and recovery
Document number: ITSOP08
Document title: Electronic Data
Procedures of operation
Continuity
for data backup and
Version: 3
recovery
Effective date: 2015-11-16
Differences from previous version: Minor
layout correction
Actual operation status of data backup:
Post completion of the Clinical Trial etc.
Written procedure for management of
data backup and recovery
Document number: ITSOP08
Document title: Electronic Data
Procedures of operation
Continuity
for data backup and
Version: 3
recovery
Effective date: 2015-11-16
Differences from previous version: Minor
layout correction
Actual operation status of data backup:
Readability of
The contents of electromagnetic records should be provided as human readable format (output to display devices, print to paper and duplicate to
Electromagnetic
electromagnetic recording media).
Records
Management Method Entry column
Throughout the conduct of the Clinical Trial etc.
T Possible £ Not possible
Feasible output format:
T Output to display
T Output to paper
Ensuring the readability T Copy to electromagnetic recording
of retained information medium
T Other (SAS programs and data, SPSS
programs and data, CDISC ODM, ASCII,
PDF)
Post completion of the Clinical Trial etc.
T Possible £ Not possible
Feasible output format:
T Output to display
T Output to paper
Securing of the visual
T Copy to electromagnetic recording
readability of stored
information medium
T Other (SAS programs and data, SPSS
programs and data, CDISC ODM, ASCII,
PDF)
Storability of Electromagnetic records should be retained in a condition under which their authenticity and readability are ensured throughout their retention
Electromagnetic period.
Records In order to ensure their storability, the following requirements should be met;
Management Method Entry column
Post completion of the Clinical Trial etc.
Written procedure of electromagnetic
records after the completion of trial
Document number:
Document title:
Version:
Effective date:
Differences from previous version:
Summary of the procedure and resulting
documents:
Actual storage condition (including audit
trails)
Medical institution
Ensuring the storage * Audit trails:
£ Available
retention period £ NOT Available
* File format, etc. :　
* Storage form
£ Electromagnetic medium (Type: )
£ Printed paper
Sponsor/MAH etc.
* Audit trails:
£ Available
£ NOT Available
* File format, etc. :　
* Storage form
£ Electromagnetic medium (Type: )
£ Printed paper
Requirements for the
Use of Electronic Whenever electronic signatures are used, the following requirements should be met in order to ensure the reliability of the electronic signatures.
Signatures
£ No　T Yes (start date if eSignature is used in the EDC system: )
Management Method Entry column
Policy / guidance for electronic signature
Document number:
Document title:
Version:
Effective date:
Differences from previous version:
Summary of the procedure and resulting Available in the online documentation for
documents: Viedoc Clinic, chapter entitled "Signing of
data".
* If it is same as the above section Version handled together with the rest of the
ER/ES 3.1.1 "Policy / guidance for online documentation, present version is
maintaining the security", it is 1.0.261.0
unnecessary to specify here.
£ Use the same procedure
Procedure to ensure the
reliability of electronic
signature

ER/ES Guideline 4.
(1) Procedures for management
and operation for electronic
77 signatures are documented and
adequately implemented in
accordance with the Law
Concerning Electronic Signatures
and Certification Services (Law
No. 102, dated 31 May 2000).
(2) Each electronic signature is
unique so as to identify each
individual, and not be reused by
or reassigned to anyone else.
(3) When electronic signatures
are executed to documents using
electromagnetic records, the
signed electromagnetic records
include information that indicates
all of the following:
78 - The name of the signer
- The date and time when the
signature was executed
- The meaning of the signature
(creation, review, approval, etc.)
(4) Electronic signatures
executed to electromagnetic
records are linked to their
respective electromagnetic
records to ensure that the
signatures are not able to be
excised and/or duplicated by
ordinary means in order to avoid Information included in
unauthorized use.
79
80
81
Written procedure for user
authentification (e.g. use of ID and
password):
Document number:
Document title:
Version:
Procedure to ensure the Effective date:
reliability of electronic Differences from previous version:
signature Summary of the procedure and resulting
documents:
* If it is the same as the above section
ER/ES 3.1.1 "Written procedures of
requesting user registration, granting
ID/password, reviewing users, removing
the registered users" and "Written
procedures for users how to use the
ID/password", it is unnecessary to
specify here.
T Use the same procedure
Others
Document number:
Document title:
Version:
Effective date:
Differences from previous version:
Summary of the procedure and resulting
documents:
T Possible £ Not possible :To clearly
identify the following information:
• Name of signer
• Date and time of signature
• Meaning of signature (creation,
confirmation, approval, etc.)
electronic signature ** Describe how eSignature is displayed
including audit trail, meaning of the
signature, etc:
Signed data is indicated by a special
"signed" icon in Viedoc. If the data is
modified then the signature is broken.
Describe the validation mechanism(s)
ensuring and preserving eSignatures
Explanation on authenticity:
"Electronic signatures This is implemented as core functionality
executed to in Viedoc. Validation of Viedoc is
electromagnetic records described in:
are linked to their Document number: DEVSOP01
respective Document title: Product Development
electromagnetic records Process
to ensure that the Version: 5
signatures are not able to Effective date: 2015-01-26
be excised and/or Differences from previous version:
duplicated by ordinary Complete rework of development
means in order to avoid process
unauthorized use." Summary of the procedure and resulting
documents:This document describes the
product development process used at
PCG Solutions.
82 5. Others
Persons intending to use electromagnetic records and electronic signatures as documents and source documents in their submissions for the
approval or licensing of medical products and for registration of conformity certification bodies should have defined the specifics related to the
83 ER/ES Guideline 5. Others
person in charge, administrators, organization, facilities, and training that are required for the use of electromagnetic records and electronic
signatures.

Entry column
84 Regulatory requirements Management Method * Provide the information about the organization who directly administers the electromagnetic records. If the sponsor / MAH actively participate in the system administration,
provide the both information

85 Throughout the conduct of the Clinical Trial etc.

Person responsible
86 Thomas Kaponen, Director

Kai Eriksson
Yusuke Nakazawa
87 Administrators Yasuya Yoshimura
Mariko Noda
Junzhen Ma

88 Organization Pharma Consulting Group KK

89 Facilities/equipment

ER/ES Guideline 5.
Persons intending to use
electromagnetic records and
electronic signatures as
90 documents and source
documents in their submissions
for the approval or licensing of
medical products and for
registration of conformity
certification bodies should have
defined the specifics related to
the person in charge,
administrators, organization,
91
facilities, and training that are
required for the use of
electromagnetic records and
92 electronic signatures.
Training
* Describe the training for
the person who
administers/maintains All of the above receive regular training
electromagnetic records. that is documented in their respective
Training for end users is Training Records at PCG Japan.
described in the above
section of "Education and
training on securing of
security"
Post completion of the Clinical Trial etc.
Person responsible

93 Administrators

94 Organization

95 Facilities/equipment

Training

* Describe the training for

the person who
administers/maintains
electromagnetic records.
96
Training for end users is
described in the above
section of "Education and
training on securing of
security"

97

98
6. "(Critical) system faults occurred and incompliance with the procedure during the trial," "Matters pointed out in previous
inspections," and improvements made
• (Critical) system faults occurred and incompliance with the
procedure during the trial
• Matters pointed out in the prior inspection
Date of the inspection / date
99 when the sponsor knew the System (version) Trial number *Such occurrence as lack of data or audit trails, data collection Improvement status (including the consideration of impact to other trials)
situation error occurred due to an error in setting an individual trial, event
which influenced blindness or safety of trial subjects,
unauthorized use of use ID and so on will be specified.

100

101

102

103
104 7. Revision history of this EDC Management Sheet
105 Revision number Document date Contents

106 1

107 2

108 3
1
EDC System Sheet (for sponsor / MAH) Operating Experience Sheet (JPMA Translation)
2 Vendor/Contracted resource
Written procedures of
(Contract for each clinical trial) *In case another written
System Trial substance Procedure of validation upon requesting user registration,
Trial In-scope of this time * The individual agreement stated in Written procedure for training procedures is to be added, Date of application for
number
Name code or product Title of the Clinical Trial etc. (Period of Clinical Trial etc.: - )
of inspection? the Operational Sheet "2.
setting of trial information granting ID/password,
on security insert a new column to Brand/trade name CTD number
(version) name (Trial specific UAT etc.) reviewing users, removing the approval
Subcontracting agreement" will be provide the information.
registered users
specified.

3 1 Name of vendor/contracted resource Document number: Document number: Document number: Document number:
Scope of outsourced services: Document title: Document title: Document title: Document title:
Contract date: Version: Version: Version: Version:
Contract period (from): Effective date: Effective date: Effective date: Effective date:
□　Yes
□　No Contract period (to): Summary of the procedure Summary of the procedure Summary of the procedure Summary of the procedure
Automatic contract renewal £No　 and resulting documents: and resulting documents: and resulting documents: and resulting documents:
£Yes Completion date of UAT:

4 2
5 3
6 4
7 5
 Revision History EDC Management Sheet (Template)
(Templ
Date of Template
ate) Revision Comment
Creation/Revision
Ver
1.0 3/27/2013 Newly Issued

Revision History EDC Management Sheet (JPMA Translation)

(Templ
Date of Template
ate) Revision Comment
Creation/Revision
Ver
1.0 6/30/2013 Newly Issued (Tanslated PMDA EDC Management Sheet template versjon 1.0)