Governing-Source Checklist

Before the outline:

• the output, design, destination, jurisdiction, lifecycle stage, and audience are precise;
• candidate source types have been inventoried;
• current controlling originals and controlled project copies are available;
• applicability and version decisions have owners;
• extensions, target instructions, procedures, and templates have been checked;
• atomic requirements have been mapped into the outline and workflow.

Before handoff:

• the document and submission package satisfy the mapped requirements;
• source, section, display, declaration, metadata, appendix, and portal checks are complete;
• conflicts, deviations, not-applicable items, and specialist interpretations are documented;
• scientific, statistical, ethical, regulatory, privacy, patient, editorial, and technical reviewers have completed the reviews assigned to them;
• the governing versions and final compliance evidence can be recovered.