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Adrian Gonzalez
Adrian Gonzalez

Pinnacle 21 Community: Download the Best Validator, Generator, and Converter for Clinical Data


Download Pinnacle 21: The Ultimate Guide for Clinical Data Compliance




If you are involved in clinical data management, analysis, or submission, you know how important it is to ensure that your data is compliant with the standards and requirements of regulatory agencies such as FDA and PMDA. You also know how challenging and time-consuming it can be to validate, transform, and document your data according to the CDISC standards. That's why you need Pinnacle 21, the gold standard for clinical data compliance.


What is Pinnacle 21 and why do you need it?




Pinnacle 21 is a suite of software solutions that help you prepare your clinical data for submission to regulatory agencies. It automates the process of validating, converting, and generating your data files, metadata, and documentation according to the CDISC standards. It also provides you with feedback and guidance on how to resolve any issues or errors that may arise during the validation process.




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Pinnacle 21 offers two main products: Pinnacle 21 Community and Pinnacle 21 Enterprise. Depending on your needs and budget, you can choose the one that suits you best.


Pinnacle 21 Community: A free and open source tool for data validation




Pinnacle 21 Community is a free and open source software that you can download from the official website of Pinnacle 21. It includes four modules: Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner. You can use these modules to validate your data against the latest set of standard validation configurations, generate Define.xml files, convert your data formats, and mine data from ClinicalTrials.gov.


Pinnacle 21 Community is compatible with Windows and Mac OS X operating systems. It also supports all CDISC terminologies starting from version 3.0. You can use it to validate your data for FDA and PMDA submissions.


Pinnacle 21 Enterprise: A premium and secure solution for data submission




Pinnacle 21 Enterprise is a premium and secure software that you can purchase from Pinnacle 21. It includes all the features of Pinnacle 21 Community, plus some additional benefits such as:


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  • Access to a web-based interface that allows you to manage your projects, users, roles, permissions, and workflows



  • Integration with your existing data standards, systems, and processes



  • Customization of your validation configurations, rules, reports, and outputs



  • Enhanced performance, scalability, security, and reliability



  • Dedicated support and training from Pinnacle 21 experts



Pinnacle 21 Enterprise is compatible with Windows, Linux, and Solaris operating systems. It also supports all CDISC terminologies starting from version 2.1.3. You can use it to validate your data for FDA, PMDA, EMA, Health Canada, Swissmedic, ANVISA, NMPA submissions.


How to download and install Pinnacle 21 Community




If you want to try out Pinnacle 21 Community for free, here are the steps you need to follow:


Step 1: Go to the official website and choose your operating system




Visit the and scroll down to the section where you can choose your operating system. You will see three options: Windows, Mac OS X, and Linux. Click on the one that matches your computer.


Step 2: Download the latest release of Pinnacle 21 Community




After clicking on your operating system, you will be redirected to a page where you can download the latest release of Pinnacle 21 Community. You will see a link that says "Download Pinnacle 21 Community". Click on it and save the file to your preferred location.


Step 3: Install the software and follow the instructions




Once the download is complete, locate the file and double-click on it to start the installation process. You will see a window that asks you to agree to the terms and conditions of Pinnacle 21. Read them carefully and click on "I Agree" if you accept them. Then, follow the instructions on the screen to complete the installation. You may need to restart your computer after the installation is done.


How to use Pinnacle 21 Community for data validation




Now that you have installed Pinnacle 21 Community, you can start using it for data validation. Here are the steps you need to follow:


Step 1: Select your validation configuration and input files




Launch Pinnacle 21 Community and click on the "Validator" module. You will see a window that allows you to select your validation configuration and input files. A validation configuration is a set of rules and checks that Pinnacle 21 uses to validate your data. You can choose from the predefined configurations that are available for different regulatory agencies and CDISC standards, or you can create your own custom configuration.


To select your validation configuration, click on the drop-down menu next to "Validation Configuration" and choose the one that matches your submission requirements. For example, if you are submitting data to FDA using SDTM version 1.7, you can choose "FDA (SDTMIG v1.7)" as your validation configuration.


To select your input files, click on the "Browse" button next to "Input Files" and navigate to the folder where you have stored your data files. You can select multiple files at once by holding down the Ctrl key while clicking on them. Your input files should be in SAS XPORT format (.xpt) or SAS dataset format (.sas7bdat). You can also select a folder that contains all your input files by clicking on the "Select Folder" button.


Step 2: Run the validation and review the results




After selecting your validation configuration and input files, click on the "Run Validation" button at the bottom of the window. Pinnacle 21 will start validating your data and display the progress and status of the validation in a new window. You will see a green check mark next to each file that passes the validation, a yellow warning sign next to each file that has warnings, and a red error sign next to each file that has errors.


To review the results of the validation, click on any file name in the window. You will see a detailed report that shows all the issues and messages that Pinnacle 21 found in your data. You can filter, sort, search, export, and print the report as needed. You can also click on any issue or message to see more information about it, such as its description, severity, location, source, rule ID, and suggested resolution.


Step 3: Generate Define.xml and other output files




After reviewing the results of the validation, you can generate Define.xml and other output files that are required for your submission. Define.xml is an XML file that describes the structure, content, and metadata of your data files. It is an essential part of any CDISC submission.


To generate Define.xml and other output files, click on the "Generate Outputs" button at the bottom of the window. You will see a new window that allows you to select the output files that you want to generate. You can choose from the following options:


Define.xml: This is the main output file that describes your data files and metadata. You can choose the version, style, and encoding of your De


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