protocol Does the project involve participant Yes No □ □ recruitment Have been significant events Yes No Summarise changes □ □ that impact on the study (SAEs, SUSARs) in the past 12 months Have findings of ethical significance Yes No Is recruitment to continue □ □ arisen at this site or elsewhere If Yes, please explain: Yes No □ □ Have participants been informed of Yes No N/A If yes, please provide a □ □ □ these events brief summary Current request extension dates ........./.........../.......... Can you explain in detail the reasons for extension
protocol Does the project involve participant recruitment Yes □ No □ Have been significant events that impact on the study (SAEs, SUSARs) in the past 12 months Yes □ No □ Summarise changes Have findings of ethical significance arisen at this site or elsewhere Yes □ No □ If Yes, please explain: Is recruitment to continue Yes □ No □ Have participants been informed of these events Yes □ No □ N/A □ If yes, please provide a brief summary Current request extension dates ........./.........../.......... Can you explain in detail the reasons for extension