Polaris

CompanySerious Adverse Subject Initials: Protocol Number:Experiences Subject #: Drug Name:(Page 1)Date of Report: Investigator Name:Sex Weight Height Date of Birth Race___ Male ___ Female ___ ___ ___ lbs. ___ ___ in.___ White ___ Black___ Asian ___ Hispanic___ Other (specify): ____________________Diagnosis (if known)or Signs / symptomsList one per line.DateStartedDD/MM/YY*Intensity*Outcome*ActionRelationshipto TrialMedication*Date StoppedPoststudyDD/MM/YY*Withdrawal*Seriousness* See facing page for codes./ / / // / / // / / /Possible causes of SAE other than trial medication Disease under study Concurrent disorder. Specify: Treatment failure Concurrent medication. Specify:Withdrawal of trialmedicationActivity related to study participation(e.g., procedures). Specify:SAE.doc© 2004 by CRC Press LLC