A best practice

guide to
CDISC SDTM mapping
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Contents Tip: Easily skip to a section by

clicking on the relevant title
• Introduction
• The CDISC SDTM structure
• SDTM mapping specification document
• The mapping process
• Typical mapping scenarios
• SDTM mapping best practice
• ryze has you covered
• What you’ve learned
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Introduction
When it comes to clinical trials, data
is everything. Timely, clear and
actionable data insights allow
important clinical decisions to be
made in real time. This means that
potentially life changing or life
enhancing medicines can be brought
to those in need faster.
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Is a drug working?
Are there side effects?
Is it safe to continue with a trial?
These are the sorts of questions that can be answered
by clear, comprehensive data analytics. But in order to
get this information, you have to first produce quality
SDTM datasets. This can mean lots of manual Excel
spreadsheet work and programming to design specs, to
get your data into the required format.

The process of mapping raw data to the SDTM format

is known as SDTM mapping.
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Whether you’re mapping to CDISC SDTM format before data collection
or after, it’s no simple task. That’s why we’ve created this guide to help
you understand what you’re up against, and what tools are out there
to help you map to SDTM more easily.

In this guide, we’ll cover:

• The CDISC SDTM structure required for any clinical trial submission
• The purpose of an SDTM mapping specification document
• A typical SDTM mapping process
• Common mapping scenarios you should be aware of
• How best practice makes mapping easier
• Some tools that can help you navigate the mapping process
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The CDISC SDTM structure
CDISC standards were put in place to allow
the US Food and Drug Administration (FDA)
to quickly analyze clinical trial data, in order For clinical trial data to be
to understand whether a drug is going to be accepted by regulatory
safe, or even work. reviewers, the submission
must be in the correct
format. If not, it may mean
lots of time, money and
hard work down the drain.
At worst, it could mean the
entire trial is jeopardized.
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Implementing CDISC standards has a lot

of benefits for the submitter:

• Greater efficiency
• Full traceability in the clinical research
process from start to end
• Allows for greater innovation
• Better data quality
• Allows the sharing of data
• Reduction of costs
• Processes are streamlined
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Typically, data is aligned with SDTM at the end of the trial after all patient
data has been collected. But this can be a challenge in many ways. The
manual work required to map already collected data to SDTM can take a
long time, which often leads to submission delays.
Later in this guide, we talk about the
best practice approach you can
adopt to avoid this headache.
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The SDTM mapping

specification document
SDTM mapping can be a complicated task, so it’s important to plan
everything out in advance. To help you do this, you’ll need an SDTM
mapping specification document. This document specifies how the raw
data is to be converted and is used by the SDTM programmer and
testing team. During the data mapping process, there’s a risk that data
can be lost or distorted.
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Consider a scenario where your source data is in text format, and

your target data should be enumerated. Unless you provide a
logical specification for how the text values should be mapped to
the required values, you might get errors in the resulting data.
The specification document helps you identify and resolve these
potential errors prior to the commencement of the data mapping.
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The specification document can

be created manually as follows:

1. Examine the CRFs and raw data and identify

which SDTM domains you need

2. Against each SDTM domain, note which raw

dataset will provide the input data

3. Against each SDTM domain, list all variables

and describe how they are to be programmed
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The SDTM mapping process

In order to be CDISC compliant, raw datasets
must be mapped from the structure used in
your clinical data management system (or
another database) to the CDISC SDTM
structure.

This can be a long, complex and daunting

process. Not least because there isn’t always a
perfect match. Below, we describe the typical
SDTM mapping process.
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Typical mapping scenarios

There are nine likely scenarios in a typical SDTM
mapping process.
Get to grips with these, and SDTM Remember >> you might need to use more
mapping becomes much more achievable. than one type of mapping to create an
SDTM variable.

1. The direct carry forward

These are variables that are already SDTM compliant. These
can be directly carried forward to the SDTM datasets, and
don’t need to be modified.
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2. The variable rename
Some variables need to be renamed in order to map to the
corresponding SDTM variable. For example, if the original
variable is GENDER, it should be renamed SEX to comply with
SDTM standards.

3. The variable attribute change

As well as variable names, variable attributes must be
mapped. Attributes such as label, type, length, and format
must comply with the SDTM attributes.

4. The reformat
The value that is represented doesn’t change, but the format
it’s stored in does. For example, converting a SAS date to an
ISO 8601 format character string.
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5. The combine
In some cases, multiple variables must be combined to form a
single SDTM variable.

6. The split
A non-SDTM variable might need to be split into two or
more SDTM variables to comply with SDTM standards.

7. The derivation
Some SDTM variables are obtained by deriving a conclusion
from data in the non-SDTM dataset. For example, using date of
birth and study start date to derive a patient’s age, instead of
manually entering the age upfront.
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8. The variable value map and new code list application

Some variable values need to be recoded or mapped to match with the
values of a corresponding SDTM variable. This mapping is recommended
for variables with a code list attached that has non-extensible controlled
terminology.

It’s also advisable to map all values in the controlled terminology, rather
than just for the values present in the dataset. This would cover values
that are not in the dataset currently but may come in during future
dataset updates.
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9. The horizontal-to-vertical data structure transpose

If the structure of the non-CDISC dataset is completely different from its
corresponding SDTM dataset, you may need to transform it to one that is
SDTM-compliant.

The Vital Signs dataset is a good example. When data is collected in wide
form, every test and recorded value is stored in separate variables. As
SDTM requires data to be stored in a vertical form, the dataset must be
transposed to have the tests, values, and unit under three variables. If
there are variables that cannot be mapped to an SDTM variable, they
would go into supplemental qualifiers.
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SDTM mapping best practice

If the above process sounds daunting, don’t worry! Our best practice
approach below explains some things you can do to help make the mapping
process quicker and easier, accelerating your time to submission.
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1. Read the SDTM Implementation Guide

Before you begin mapping, it’s important to have a basic
understanding of how SDTM works. Read through the whole SDTM
Implementation Guide (SDTMIG) at least once. It’s an essential
resource to help you with data mapping. Before programming on a
specific domain, read the part in the guide about that domain.
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2. Implement SDTM from the start of your trial
When data is aligned with SDTM at the end of the trial, trying to make it fit the SDTM
structure retrospectively can be a headache. It takes a lot of time and manual work to
retrospectively map data, and this will lead to submission delays.

So, best practice is always to align with CDISC standards before you collect any patient
data. In fact, we recommend you consider the SDTM format when designing your case
report forms (CRFs). Doing it this way means you’ll save a lot of time and effort
manually mapping the data down the line. And it’s much easier and less time
consuming to pull your submission deliverables together.

This means you can submit your study

much quicker!
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3. Map your data upfront

EDC build can be a lengthy process, not to mention
the time it takes to gather first patient data. This
means it can be many weeks before you can see
how data and metadata look and start the SDTM
mappings.

So, what if you could see what your EDC datasets

will look like before you get them? There are
solutions to help you create simulated datasets
before you’ve collected any patient data. That way,
you get SDTM conversion done early on, and can
check that your datasets will meet regulatory
requirements. You also get a head start on mapping
your ADaM datasets back to SDTM.
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4. Do SDTM dataset validation

Another important step is CDISC SDTM validation: this means validating SDTM dataset
designs against CDISC standards (SDTM-IG, NCI controlled terms etc).

The FDA and PMDA publish compliance rules for clinical data submissions, including
SDTM. The output must ultimately be compared against the rules, and any deviations
must be resolved or fully documented. Validation is a crucial way to increase data
quality while reducing time spent in development and review.

By building in SDTM compliance at the start of your trial, you maximise compliance
throughout the process. Key factors such as correct use of controlled terms must be
built into the EDC CRFs and SDTM conversion process. This includes EDC edit check
programming and data management checks programmed to highlight data issues early.
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ryze has you

covered.
An automation platform like ryze can help
you align with these best practice methods,
save time and avoid delays.
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1. Design CRFs to capture all the required data, in a

standardized format. With ryze, the process is as
follows:

• For each CRF, decide what SDTM domain it should map to

• For each question on the CRF, decide on a corresponding
variable in the related SDTM domain. If there's any that
don't correspond to SDTM, then add custom domains
• Create raw datasets based on your CRFs
• Add your mappings to map the raw datasets to SDTM
variables
• Add your CRF page links to variables in your SDTM datasets
• Automatically create your SDTM datasets
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2. Ditch the spreadsheets! ryze helps with SDTM mappings, and does
conversions for you

ryze SDTM mapping tools make creating and describing your SDTM mappings much easier.
They let you make and validate both simple variable to variable mappings, and more
complex mappings with many steps. With ryze you can easily build SDTM datasets,
without needing to manually program spreadsheets.

And, the process of creating your SDTM mapping specification document is made easier
with ryze. The platform automatically generates the document from a dataset mapper
plug-in and lets you visualize the specification as you go.
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You can also:

• Create human-readable mappings

You can make human-readable mappings that clearly
describe how datasets and variables in your original
(source) datasets map to their equivalents in SDTM.
From there you can create a metadata specification for
programmers.

• Create machine-readable mappings

No programming knowledge is needed. Once your
mappings are done and approved, use our templates to
turn your source datasets into SDTM datasets.
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3. Quick and easy SDTM conversion

Once mappings are done, the next step is to convert
them to CDISC SDTM. With ryze, this process is just a
click away. ryze makes SDTM dataset creation far
easier, with CDISC SDTM metadata templates. That
way you build your datasets in line with CDISC SDTM
rules, right from the off. And our CDISC validation
tools prompt you about any non-compliance as you
go!
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There’s plenty more benefits too:

You don’t need to be an expert in SAS, or do any programming!

You can even convert your legacy datasets

If you standardize your mappings, you can reuse them over and over
again. That means faster study designs, and better-quality data

You can get reports that give you full traceability of all mappings to
ensure data is accurately mapped

Once you’re set up, it’s only one click to get your SDTM datasets and
define.xml
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What you’ve learnt:

✓ The purpose and importance of the CDISC SDTM structure

✓ That its best practice to consider SDTM up front, before you begin
collecting data

✓ The process for mapping raw datasets, and how using an SDTM
mapping specification document can help identify problems before
they happen

✓ The most common mapping scenarios you’re likely to encounter, and…

✓ How tools like ryze can help you navigate the mapping process while
saving time and effort!
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What’s next?
ryze is an effective solution to your SDTM mapping challenges.
By standardizing the mapping process, you’ll maximize your chances of
success and save time and effort on future trials.
Interested in seeing a short demo?
There’s no commitment and it’s totally free!