Dear OHDSI-Community,
we recently published a set of document templates which can help with regulatory compliance when implementing and operating an OHDSI software stack. The overall concept is described here.
The document templates are available in English and German on GitHub and can be used and redistributed freely. The documents are available in markdown format, so that they can easily be translated into other languages and converted into different file formats for document processors.
We hope that this is useful to others. Contributions are highly welcome. Please feel free to open an issue or a pull request with further suggestions, ideas, and improvements on GitHub at any time.
In case you have any questions or require assistance, please do not hesitate to reach out to @fabian.prasser@bih-charite.de, @felix-nikolaus.wirth@bih-charite.de or @michael.franz@charite.de.
Kind regards,