Transcript Title
Analysis Table Translation Tool
-From English to Chinese
Jessie Zhao, intern
Mina Chen, intern
Shengying Cheng, Project Manager of the Internship Program
Yanyun Shen, Site Head of APAC Statistical Programming & Analysis
GLOBAL BIOMETRICS
Biostatistics
Clinical Data Management
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Operations
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Topics
I. High level introduction about the project
II. Table translation process and tool features
III. Recommended working process
GLOBAL BIOMETRICS
Biostatistics
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High level introduction about the project
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Example
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Example
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Why is it necessary to develop this tool?
According to sFDA (State Food and Drug Administration)
requirement, all CSR including in-text tables should be in Chinese
Previously the translation was performed manually by vendor
companies which require statisticians and clinical science’s review
which is both costly and extra time consuming
There was risk to edit the statistical result incidentally
Due to system restrictions from the company, Chinese analysis
tables can not be generated directly from SAS software
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What’s the benefit of this tool?
Produce high quality tables in Chinese
To translate AE terms, we utilize the MedDRA and its Chinese translation
published by MSSO (Maintenance and Support Services Organization)
Quality check is not necessary to be repeated once we have a dictionary to
translate some other frequent used terms
Accelerate the submission
Reduce the time for CSR translation
Our colleagues will save time for checking the quality and discussion back and
forth
Our colleagues don’t need reformat the translated tables manually because we
can generate the Chinese tables with the same format as those tables in English
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What’s the benefit of this tool? (cont.)
Efficiency gains
This tool can be reused for any studies in any therapeutic areas
This tool is user friendly. It’s very easy to learn how to use it
It’s applicable to translate tables from English to other languages
It can be used for other language translation by using the same program
We only need update the dictionaries
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Challenges
We can’t translate medication terms as the same way as we
translate adverse event terms.
We are using in-house dictionary which is only in English to do
medical coding for medication.
The company didn’t purchase WHODD (WHO Drug Dictionary)
which has Chinese translation for medication terms
There are two ways to solve this issue, either to create our own
Chinese translation for all medications used in our studies or
purchase any commercial dictionary. It needs to be further
investigated.
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Biostatistics
Clinical Data Management
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Introduction of the Tool Design and the Features
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Tool Design
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
GLOBAL BIOMETRICS
Biostatistics
Clinical Data Management
Epidemiology & Patient Reported Outcomes
Statistical Programming and Analysis
Operations
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Tool Design (Continued)
Step 1
Step 2
Source
Import
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
Step 3
Data
processing
•Combine the
wraped terms into
one line
Step 4
Step 5
Step 6
Translate
Review
Report
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
NEOPLASMS BENIGN, MALIGNANT AND
UNSPECIFIED (INCL CYSTS AND
POLYPS)
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
AE term – MedDRA
Medication term & others – translation dictionary
(Ongoing)
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
one-to-one mapping
No duplicated terms
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Clinical Data Management
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
GLOBAL BIOMETRICS
Biostatistics
Clinical Data Management
Epidemiology & Patient Reported Outcomes
Statistical Programming and Analysis
Operations
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
1
2
3
4
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
• Use translation tool to
find terms which have
no relative Chinese
translation
• Add those terms into
translation dictionary
and highlight them
• Send the excel file to
Biostatistician and
Scientist to confirm the
translation
• Save the checked
translation into library
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Tool Features
Quality can be guaranteed
No need to add or remove any spaces in translated tables manually
MedDRA is utilized to translate adverse events
Any new terms will be confirmed with Biostat and Scientist prior to translation
Column width can be defined automatically
Long terms can be wrapped automatically
It’s flexible to translate multiple columns in one table synchronously
It’s easy to identify if there is no relative Chinese translation for any
terms
Titles, footnotes and column names should be translated separately
Table format is the same as the one in English
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Table examples
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Table examples
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Table examples
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Table examples
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Tool Design (Continued)
Step 1
Step 2
Step 3
Step 4
Step 5
Step 6
Source
Import
Data
processing
Translate
Review
Report
•Table in txt file is
the source
•Add separator “|”
in the table
• Save the table
into a dataset
•Combine the
wraped terms into
one line
•Translate English
terms into Chinese
• Confirm the
translation with
Biostatistician and
Scientist
•Create the table in
Chinese
(RTF/PDF/TXT)
TXT FILE.txt
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Current limitation and further investigation
Limitation
• We can’t translate medication
terms in an efficient way for
now
a) We are using in-house
dictionary which is only
in English to do
medical coding for
medication
b) Roche didn’t purchase
WHODD (WHO Drug
Dictionary) which has
Chinese translation for
medication terms
Investigation
• Two options to translate
medication terms
a) Create our own
Chinese translation
for all medications
used in our studies
b) Purchase any
commercial
dictionary. It needs to
be further
investigated
GLOBAL BIOMETRICS
Biostatistics
Clinical Data Management
Epidemiology & Patient Reported Outcomes
Statistical Programming and Analysis
Operations
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Recommended working process
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Recommended working process
Suggestion to biostatistician and scientist
Add identifier for tables which need translation in LOPO to ensure most of tables
would be translated prior to CSR generation
Continue to add identifiers in LOPO prior to CSR finalization and update with
SPA
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Summary
This tool can translate tables from English to Chinese (or other
languages) in good quality
It has great potential to accelerate the submission
Need further investigation to solve current limitations
It is a great internship program to provide an opportunity for staff
development
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Thank you!
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