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Now fill out the AE document Lets fill out the AE Page Subject: 99-045 Event: Migraine Onset Date: 31-MAY-2005 Resolution Date: 1-JUN-2005 Severity: Relation to Study Drug: Action Taken: Medication (Excedrin Migraine) Outcome: Recovered Serious: NO Concomitant Medications All medications need to be recorded (including, supplements, vitamins and topical medications) Get as much information (dose, route, frequency etc) as you can the first time Make sure that AE form is completed if the conmed indication was an AE Lets fill out the Con Meds Source Page Medication: Excedrin Migraine Dosage: 2 Tablets Administration Route: Oral Frequency: Every 8 hours Indication: Migraine Date Started: May 31st, 2005 Date Stopped: June 1st, 2005 Helpful Hints If a medication changes, ask why, the underlying cause may need to be recorded as an adverse event Document Reasons for all missed visits or out of window visits These may be due to an AE that may need to be recorded Overall Some Helpful Hints KEEP ALL STUDY RELATED DOCUMENTS Even if they seem outdated file in the regulatory binder or in patient binders Write EVERYTHING down, before you forget Put subject numbers on every piece of paper So you know which subject it belongs to Address all issues in your monitor follow up letters ASAP Initial and date everything When in doubt initial and date anyway

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Both deserve a fair answer