Polaris

SOP# SITE-010.0CompanyEffective Date: DD/MMM/YYIII.ProceduresA. DefinitionsAll study staff will use the definitions of “adverse experience” and “serious adverseexperience” found in the protocol and FDA regulations.For clinically significant lab abnormalities, the study staff will follow the Sponsor’sinstructions or the protocol to determine if such abnormalities meet the definition ofan SAE.B. Non-Serious Adverse Experiences (AEs)1. The Investigator or Study Coordinator will inquire about adverse experiences ateach study visit and will document the inquiry in the subject’s medical chart. Ifan adverse experience is found, the Study Coordinator will document thefollowing in the subject’s chart and Case Report Form:a. Date and time (if applicable) the event started and endedb. Description of the eventc. Severity of the eventd. Outcome of the evente. Action takenf. Relationship to study drug2. The Investigator will determine the relationship of the event to the study drug andwill record this in the subject’s chart.3. The Investigator will follow-up on all drug-related AEs until they are resolved oruntil it is determined to be a permanent condition.C. Serious Adverse Experiences (SAEs)1. Reporting Timeframes – As soon as a study staff member becomes aware of aSAE, he/she will ensure that the following people are notified in the timeframeslisted below:a. Principal Investigator and Study Coordinator – immediately.b. Sponsor/Contract Research Organization (CRO) – in the timeframe stated inthe protocol, but no later than 48 hours. If the SAE is life-threatening or adeath, the Sponsor/CRO will be notified within 24 hours.c. Institutional Review Board (IRB) – In the timeframe required by the IRB, butno later than 48 hours.SITE-010.0.doc© 2004 by CRC Press LLC