Define-XML
Have your Define.xml files ready to submit up to 80% faster
Automate creation of Define.xml – without coding
Define-XML is a mandatory part of your regulatory submission for SDTM, SEND and ADaM datasets. But preparing your define.xml files, dataset metadata, aCRF, and reviewer’s guide, is a time-consuming manual job. Many studies fail because of faulty define.xml files. So you need to make sure your submission is clear, accurate and complete to stand any chance of gaining approval.
Our define.xml tool removes the risk of getting your define.xml wrong! By automating the creation of define.xml you also save significant time and effort – resulting in a faster and more efficient means of generating submission deliverables. The Pinnacle 21 Enterprise platform also helps you create a thorough and credible Reviewer’s Guide, with automation replacing manual processes. Then push a button, and out pops your Reviewer’s Guide!
Why make define.xml in Pinnacle 21 Enterprise?
Get faster define.xml
Automatically create define.xml files for SDTM, SEND, and ADaM. Simply edit and manage files like a spreadsheet! You can also import spreadsheets to instantly convert to XML format. The platform auto-populates origin page numbers from your annotated CRFs, saving even more time!
Accurately predict your define
When you design forms for an EDC in P21E, the platform accurately predicts the define.xml for the datasets that would be created – based on your form design. That way you’ll have submission deliverables to work on from the very start of your study, rather than waiting until the end and risking costly delays.
Visualize define.xml
Preview your define.xml metadata in PDF, or using the published CDISC stylesheet. This includes full definition of the define, page links to annotated CRFs, and hyperlinks to submission datasets. Now you can check how your define looks and easily collaborate with stakeholders.
Version control
You can update and version your Define.xml files in P21E, giving you complete visibility and control. Assess changes over time by comparing studies, study versions, or comparing content with standards.
Built-in validation
Any errors or invalid entries are instantly highlighted in real-time. So validation is baked in from the start, and you can be confident your define.xml is flawless! Even import existing spreadsheets, SDTM or ADaM datasets into the platform and validate in real-time. All that’s left is to extract your final define.xml file at the click of a button!
1 click Reviewer’s Guide
Keep reviewers happy by submitting clear and complete data. Easily share context and pre-empt questions in the Pinnacle 21 Enterprise platform. Our tool automates content aggregation and formatting, allowing further time savings. Then it’s just one button click to generate your submission ready Reviewer’s Guide.
How you’re better off with P21E’s Define.xml tool
Increase chances of approval
Being a required study deliverable, it’s essential to quickly and correctly create your define.xml files. Now you can avoid costly study failures and put yourself in the best position for approval. Our automation tools and in-stream validation help you produce accurate define files from the start. You’ll avoid end-of-study delays and instead have timely, compliant submission deliverables!
Maximize resources
With our code-free define tool, you don’t need to be an expert programmer to create high quality submission deliverables. Automation replaces manual work, resulting in time and cost savings. And expensive programming resources can be diverted to higher value programming projects.
Speed drugs to market
With faster, accurate define creation and no end-of-study delays, clinical trials can be submitted earlier compared with traditional, manual methods. As a result, sponsors can bring new approved drugs to market sooner, and start realizing profits far earlier.
8 best practice steps and 10 mistakes to avoid when creating a compliant Define.xml submission
How to create Define.xml with P21E
When you design dataset metadata specifications in P21E, you know they’ll be compliant. That’s because we’ve embedded the Define-XML standard into the dataset design process. This reduces efforts to create compliant metadata, since compliance is built in from dataset design.
SDTM, ADaM and SEND are incorporated into an easy to use define structure. All aspects of the define.xml are captured, to ensure a valid submission. For example, you can create Analysis Results Metadata (ARM) for ADaM, and we’ve given you the tools to describe ARM for a study.
We know Define-XML – so you don’t have to
Our team has many years of experience working with CDISC standards – including Define-XML. We’re members of the Define-XML Development team and played a key role in the development of the Define-XML 2.0 and 2.1 standards. We’ve drawn on this knowledge to incorporate key CDISC requirements in our Define.xml tool.
Get submission deliverables up to 80% faster with the Pinnacle 21 Enterprise Define.xml tool
Define FAQs
Submission to regulatory agencies require both data and metadata from clinical trials. A major component of this is the data definition file – or the define.xml. The define.xml is the metadata describing the content and formatting of submission datasets. Here’s an example SDTM define.xml pdf file.
The Define-XML standard is based on the CDISC Operational Data Model (ODM) XML schema. Being vendor neutral and platform independent enables the exchange of clinical study data in a non-bias format. As such it is required for study submission to the FDA and other regulatory agencies.
Get a free demo of Pinnacle 21 Enterprise Clinical Data Management & Automation Suite
Complete the form to book your no-obligation demo of the P21E Clinical Data Management & Automation Suite… and see how better off you could be!
