TMPL_058 Breaches log Study title: R&I reference number: description of breach Date Date Corrective Action (if CAPA Preventative Date all If identified as Additional identified breach breach completed refer to Action (if actions Serious date comments occurred notified to relevant CAPA form) CAPA completed reported to Sponsor completed REC/MHRA (as to applicable) relevant CAPA form)
TMPL_058 Breaches log Study title: R&I reference number: description of breach identified Date breach occurred Date breach notified to Sponsor (as applicable) Corrective Action (if CAPA completed refer to relevant CAPA form) Preventative Action (if CAPA completed to relevant CAPA form) Date all actions completed If identified as Serious date reported to REC/MHRA Additional comments
tmpl_058_breaches_log_v1.0_12.01.17.docx