Unlocated Ers Temporary Closed For Publication -set 4- Final

| Aspect | Detail | |--------|--------| | Cutoff date | Fixed, no extension | | Unlocated ER count threshold | Must be zero for active status; any number allowed if temporarily closed | | Publication output | Clinical Study Report (CSR), integrated summary, or journal manuscript | | Post-publication reopening | Permitted only under a formal deviation request | | Audit requirement | Full traceability of closure and reopening |

Operational Protocol and Impact Analysis: Temporary Closure of Unlocated ERs for Publication – Set 4 (Final) Date: October 26, 2023 Subject: Database Integrity, Publication Standards, and Legacy Entity Management Unlocated ERs Temporary Closed for publication -SET 4- final