Define-XML
准备好 Define-XML 文件，提交速度可提高 80%
无需编码即可自动创建 Define-XML
对于 SDTM、SEND 和 ADaM 数据集而言，Define-XML 是提交监管文件的必备部分。但是，准备 Define-XML 文件、数据集元数据、aCRF 和审稿人指南是一项耗时的手工工作。许多研究的失败都是因为 Define-XML 文件有问题。因此，您需要确保您提交的材料清晰、准确、完整，这样才有机会获得批准。
我们的 Define.XML 工具消除了您的 Define.XML 出错的风险！通过自动创建 Define.XML，您还可以节省大量的时间和精力，从而更快、更高效地生成提交成果。Pinnacle 21 Enterprise 平台还可以帮助您创建全面、可信的 Reviewer's Guide，用自动化取代人工流程。然后按下一个按钮，就会弹出 Reviewer's Guide。
为什么要在 Pinnacle 21 Enterprise 中制作 Define.XML？
更快地获取 Define.XML
自动为 SDTM、SEND 和 ADaM 创建 Define.XML 文件。只需像电子表格一样编辑和管理文件！您还可以导入电子表格，立即转换为 XML 格式。该平台会自动从您已加注释的 CRFs 中填充原产地页码，从而节省更多时间！
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.
加快药品上市速度
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.
Get submission deliverables up to 80% faster with the Pinnacle 21 Enterprise Define.xml tool
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.
Instantly convert Define.xml v1.0 to v2.0 and create your Analysis Result Metadata (ARM) in Pinnacle 21 Enterprise
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.
