Create ADaM datasets easier and get full traceability of data with ryze

Standardize and reuse your ADaM datasets

ryze clinical trial automation software helps you standardize your ADaM datasets before you’ve collected any patient data. That way, you can check that your datasets will meet regulatory requirements early on. Approved standards can be stored and managed within ryze, so they can be easily found and reused. So, you’ll be able to build studies faster and datasets will be consistent from study to study.

ADaM dataset specifications made easy

With ryze, variables shared between SDTM and ADaM datasets are standardized. This means you can quickly map to your datasets without needing to unpick any data, avoiding delays in the submission process.

Standardize ADaM datasets before collecting any patient data in ryze

Full traceability of your ADaM data

When it comes to ADaM, traceability is key. It facilitates transparency and builds reviewer confidence in the data itself. Using ryze, you’ll get full traceability of your ADaM datasets, and a clear understanding of the relationship between the analysis results, and the source data. You’ll be able to share standardized variables between datasets, as well as easily see content relationships and the origins of your ADaM data.

Access a built-in standards library

There’s no complex coding in ryze. Instead, you’ll get access to a built-in content library, containing CDISC-compliant published standards. These standards will help you create your ADaM dataset specifications, and give you confidence that they meet regulatory requirements. You can also define your own organization-specific ADaM dataset standards based on these published standards, and build your studies from those.

How you’re better off with ryze

Store, manage and reuse content – all in one place

Create and reuse metadata assets, such as ADaM datasets, controlled terminology, derivation methods, comments, and analysis results metadata by creating organizational standards based on our built-in templates.

Share content between datasets, and see relationships

Traceability allows reviewers to see not only the analysis dataset, but to track exactly where the data has come from. Using our templates, you can create your ADaM datasets from published standards. You’ll get full end-to-end visibility of data lineage from data collection, through RAW datasets, and all the way to SDTM and ADaM.

Get ADaM datasets and start analyzing your data faster

Storing your ADaM dataset definitions in ryze helps you produce the ADaM dataset data faster. And, you can get from first patient data to SDTM is as little as 2-4 weeks. That means you can begin analyzing your data much faster than with traditional study methods.

Visualize your ADaM Define file

When you build your study in ryze, you can visualize your ADaM define.xml as you go. Then, instantly create the file with a single click!

Easily produce reviewer’s guide

Along with your ADaM data and define.xml, you’re required to submit an analysis data reviewer’s guide, to help regulators understand the analysis data content of your study. A draft of this guide can easily be created in ryze from existing content, and further developed ready for submission.

Increase the quality and consistency of studies

Add domains and variables that are automatically compliant with CDISC standards. You’ll increase quality and consistency of study data, and save time on study build!

ADaM dataset design

Our clinical metadata management tools help ensure that your datasets comply with CDISC ADaM standards, as well as SDTM, Define-XML, CDASH and SEND. There are several ways to create ADaM dataset metadata in ryze:

Use the Published ADaM Standard

Include analysis variables and classes such as Subject Level Analysis (ADSL), Basic Data Structure (BDS), and Occurrence Data Structure (ODS).

Create other classes

ryze provides the ADSL, BDS, ODS and Time-to-Event (ADTTE) dataset classes by default. You can also manually build your own datasets and variables within ryze.

Clone variables

ryze lets you clone and edit from SDTM variables already in your metadata repository. As a result, you can quickly create a new ADaM variable while keeping the link to the original SDTM variable.

SDTM mapping and conversion

ADaM and SDTM go hand-in-hand. Our CDISC SDTM mapping tools let you make and validate simple variable to variable mappings, as well as more complex mappings with many steps.

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FAQs

What is CDISC’s Analysis Data Model (ADaM) standard?

ADaM standards outline how to create analysis datasets and associated metadata. This allows a statistical programmer to generate figures, listings, and tables more easily, and ensures traceability. In turn this means that reviewers are able to assess and approve a submission more quickly.

What is the difference between SDTM standards and ADaM standards?

CDISC built SDTM to provide a standard way to organize and format data in order to streamline the processes of collection, management, analysis and reporting of clinical trial data.

While SDTM is used to create and map collected data from raw sources, to ease statistical review, ADaM is all about creating data that’s ready for analysis. ADaM datasets should always be derived from SDTM.