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The following is latest release of Pinnacle 21 Community, which includes Validator, Define.xml Generator, Data Converter, and ClinicalTrials.gov Miner. The download also contains the latest set of standard validation configurations.
Pinnacle 21 Community 3.1.2
DOWNLOAD FOR WINDOWSPinnacle 21 Community 3.1.2
DOWNLOAD FOR MAC OS XTo view Release Notes for the application: Open Community and select to Help > Show App Changelog
Release Notes - Validation Engines
CDISC Terminology
Pinnacle ID provides all CDISC Terminologies starting with Community 3.0. You can download CDISC Terminology for 2.1.3 and 2.2.0 here.
Define.xml Stylesheets
English
Chinese
Japanese
Installation and Usage
The following are basic installation and usage instructions. For additional information, please refer to documentation.
Installing Pinnacle 21 Community
MedDRA Installation
WHODrug Installation
SNOMED Installation
Compatibility with Enterprise
Pinnacle 21 has executed a series of tests on Pinnacle 21 Community and Pinnacle 21 Enterprise in the Pinnacle 21 test environment, and the testing suggested compatibility between the validation results from the two products. The list of compatible versions are listed in the table below. However, due to the nature of open source projects, actual sponsor results may differ based on a variety of factors outside of Pinnacle 21’s control, including (but not limited to) the sponsor's environment and how Pinnacle 21’s products are deployed. You understand that Pinnacle 21 Community is a free, open source project, and is solely made available by Pinnacle 21 on an “As Is” and “As Available” basis. Therefore, Pinnacle 21 makes no representations, warranties or guarantees of any kind with respect to the validation results generated by Pinnacle 21 Community, including but not limited to any representation, warranty, or guarantee of accuracy or compatibility with any other products, standards, or requirements. You agree that Pinnacle 21 has no liability for any failure of Pinnacle 21 Community, and/or any inadequacy of the results generated by Pinnacle 21 Community, including but not limited to any failure of compatibility.
| Community Version | Enterprise Version | Agency | Engine Version | Notes |
| 3.0.0+ | 4.0.0+ | PMDA | 1511.6 | Validation engine for PMDA rules version 1.0. Valid for use with applications from October 1, 2016 through March 31, 2021. |
| 3.0.0+ | 4.0.0+ | PMDA | 1810.3 | Validation engine for PMDA rules version 2.0. Valid for use with applications from April 1, 2020. |
| 3.0.0+ | 4.0.0+ | FDA | 2010.1 |
License
Pinnacle 21 Community is free software licensed under the Pinnacle 21 Open Source Software License. To learn more about our license check out the FAQ.
Source Code Repository
Pinnacle 21 uses the Bitbucket source code control system for all of its source code. Although only active contributors get write access to the repository, anyone can browse our repository anonymously at https://bitbucket.org/p21-community/
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