Deploying and maintaining an OHDSI installation can be challenging. While container technology has significantly simplified deployments from a technical perspective, regulatory compliance can remain a major hurdle. In this repository, we provide a comprehensive set of document templates designed to streamline the data protection and information security-relevant documentation and coordination efforts required to establish OHDSI installations. The documents are provided in different languages:
If you have questions, encounter any problems or want to suggest changes or additions, we would like to invite you to open an issue on GitHub. If your request contains confidential information or is not suited for a public issue, send us an email.
The documents are licensed under the Apache License 2.0. The full text is accessible in the LICENSE file.
To reference our work, please use the following citation:
Wirth FN, Abu Attieh H, Prasser F. OHDSI-Compliance: A set of document templates facilitating the implementation and operation of a software stack for real-world evidence generation. Front. Med. 2024;11. https://doi.org/10.3389/fmed.2024.1378866