D2.8 EU-SRS Data Management Plan

This deliverable presents the Data Management Plan for EU-SRS. Substance data in EU-SRS in managed by the SVG and this deliverable is intended to be used to support their daily activities in EU-SRS. The Data Management Plan for EU-SRS is also used by the EMA team to support their substance management activities in SMS.
The following EU-SRS User Guides are part of this deliverable:
► General EU-SRS User Guide
► Read-only EU-SRS User Guide
► Chemicals EU-SRS User Guide
► Polymers EU-SRS User Guide
► Mixtures EU-SRS User Guide
► Proteins EU-SRS User Guide (with a particular focus on monoclonal antibodies)
► Nucleic Acids EU-SRS User Guide
► Human Vaccines EU-SRS User Guide
► Veterinary Vaccines EU-SRS User Guide
► Homoeopathic Substances EU-SRS User Guide
The EU-SRS User Guides are living documents and will be updated when new best practices are being developed. This may occur for substance types that are already covered, but also guidance on additional substance types will be part of the developments.
This deliverable is intended to be published in the public domain to share knowledge about correct substance management in compliance with ISO IDMP and to support transatlantic alignment.