SAE Processing Plan and SAE Reporting Plan
Unblinding Plan
Management of SAEs and Pregnancy Reports
Receipt Initial/Follow-up SAE Report/Pregnancies from Site: send information to Sponsor upon receipt
Translation of SAE or pregnancy reports, lab results or other source documents into English when required
Generate urgent queries for missing information/clarification
Safety database entry (in sponsor's database, MedDRA coding included)
Generate SAEs/pregnancy narratives
Identification of potential SUSAR (provide assessment of expectedness and causality) and SUSAR preparation and submission
Prepare and provide regulatory reporting forms (on a CIOMS I form – blinded + unblided)
Prepare EC SUSAR letters, prepare Investigator SUSAR letters
Electronic submission of SUSARs to the corresponding Regulatory Agency and submission of SUSAR cases to Investigators
Preparation of Annual Safety Reports (DSUR)
