TM119-A ADVERSE EVENT (AE) REPORT LOG PLEASE Study Title: ARCHIE (The early use of Antibiotics for at Risk CHildren with InfluEnza in Site Name: primary care) READ Principal Investigator: Dr Kay Wang INSTRUCTIONS BEFORE COMPLETING PARTICIPANT ID: _ _ _ / _ _ _ _ Relationship Adverse AE details Name of to study drug Event ID entered into Is the person (must be (to be Date of clinical Date of Adverse completed Severity entering AE assessed by Onset study Adverse Event Outcome Resolution Event by (diagnosis [if known] or [1-3] to log and medically dd / mm / database coordinating signs/symptoms) [1-6] dd / mm / yyyy serious? date yyyy qualified centre or (tick when [1-6] entered individual) site) entered) [1-4] / / / / 01 / / / / 02 / / / / 03
Study Title: ARCHIE (The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care) Site Name: Principal Investigator: Dr Kay Wang TM119-A ADVERSE EVENT (AE) REPORT LOG PLEASE READ INSTRUCTIONS BEFORE COMPLETING 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 study database (tick when entered) Adverse Event ID (to be completed by coordinating centre or site) / / / / 01 / / / / 02 / / / / 03