Verteporfin photodynamic therapy for neovascular age-related ...

114 Appendix 18. Recording adverse reactions and eventsAll adverse reactions (during or just after treatment) or events (between treatmentvisits) must be recorded in the database. Any adverse reaction or event consideredto be serious and possibly, probably or definitely associated with treatment must bereported to the Data Management Centre within 24 hours in accordance with GoodClinical Practice in research (see contact details, section 13.4).Adverse reactions may occur during or just after treatment, and adverse events atsome time during the interval between visits. The database records adversereactions and events in different ways:• Adverse reaction during or just after treatment; the database contains amandatory, yes/no, field which must be completed on any visit on whichtreatment is given. If the treating ophthalmologist enters ‘yes’, additional detailsmust be completed. Finally, the treating ophthalmologist must make a judgementabout the likelihood of the event being attributable to the treatment; this field ismandatory.• Adverse event since last visit; the database contains a mandatory, yes/no, fieldwhich must be completed on any visit following a visit on which a treatment isgiven. If the treating ophthalmologist enters ‘yes’, additional details must becompleted. Appropriate details should be completed for as many of these fieldsas necessary, including the (approximate) dates of onset and resolution of theevent. Finally, the treating ophthalmologist must make a judgement about thelikelihood of the event being attributable to the treatment; this field is mandatory.A reduction in the number of letters read in a treated of ≥ 20 letters should alwaysbe considered an adverse event.