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)