PARTICIPANT ID: _ _ _ / _ _ _ _ AE details Adverse Relationship Name of entered Event ID to study drug Is the person into (to be (must be Date of Date of Adverse completed Severity entering AE clinical assessed by Onset Adverse Event Outcome Resolution Event by (diagnosis [if known] or [1-3] to log and medically dd / mm / coordinating serious? signs/symptoms) [1-6] dd / mm / yyyy yyyy date database qualified centre or [1-6] entered (tick when site) individual) entered) [1-4] / / / / 04 / / / / 05 / / / / 06 / / / / 07
PARTICIPANT ID: _ _ _ / _ _ _ _ Adverse Event (diagnosis [if known] or signs/symptoms) Date of Onset dd / mm / yyyy Outcome [1-6] Severity [1-3] Relationship to study drug (must be assessed by medically qualified individual) [1-4] Date of Resolution dd / mm / yyyy Is the Adverse Event serious? [1-6] Name of person entering AE to log and date entered AE details entered into clinical database (tick when entered) Adverse Event ID (to be completed by coordinating centre or site) / / / / 04 / / / / 05 / / / / 06 / / / / 07
tm119-a-adverse-event-form-v3-1-11-aug-2014.docx