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When a change effects the elements of a Synapse table related to a project governed by GCP practicescontrols, the issue ticket must be generated by the Scientific Project Lead of the relevant project who has the Investigator role. A change request may be documented in Jira by any project member, but the issue must also be rendered in PDF form, approved and signed by the Investigator, and attached to the Jira issue. As a record of primary data, changes to Synapse tables are always considered "material" in the sense that the change effects the integrity of the project in the long term.