Have trial been any Suspected Unexpected Yes / No Serious Adverse Reactions (SUSARs) in this in the ? Have these SUSARs been notified to the Yes / No Committee within 7/15 days under Article 17 of EU Directive? If no, please arrange urgently and give reasons for late notification. What is the reporting date for periodic safety reports to the main REC during this trial? This is the date of first authorisation of the trial in any EU member state or, if the sponsor is the Marketing Authorisation Holder, the International Birth Date for the product. Has a 6 monthly safety report been submitted? Yes / No / Not applicable Applies only to commercial sponsors undertaking this trial or other trials of the IMP outside the . Has the Annual Safety Report been submitted? Yes / No / Not yet due When is the next ASR due? 7. Amendments Have any substantial amendments been made to Yes / No the trial during the year? If yes, please give the date and amendment number for each substantial amendment made. 8. Serious breaches of the protocol or Good Clinical Practice Have any serious breaches of the protocol or GCP occurred in relation to this trial during the year? Yes / No Under the Clinical Trials Regulations, all serious breaches must be notified to the MHRA GCP inspectors within 7 days of the matter coming to the sponsor’s attention. If yes, please give the date of each notification to the MHRA. Please provide the REC with a copy of each notification for information (unless previously notified). 9. Other issues Are there any other developments in the trial that Yes / No you wish to report to the Committee? Are there any ethical issues on which further advice Yes / No is required?
Have been any Suspected Unexpected Serious Adverse Reactions (SUSARs) in this trial in the ? Yes / No Have these SUSARs been notified to the Committee within 7/15 days under Article 17 of EU Directive? If no, please arrange urgently and give reasons for late notification. Yes / No What is the reporting date for periodic safety reports to the main REC during this trial? This is the date of first authorisation of the trial in any EU member state or, if the sponsor is the Marketing Authorisation Holder, the International Birth Date for the product. Has a 6 monthly safety report been submitted? Applies only to commercial sponsors undertaking this trial or other trials of the IMP outside the . Yes / No / Not applicable Has the Annual Safety Report been submitted? Yes / No / Not yet due When is the next ASR due? 7. Amendments Have any substantial amendments been made to the trial during the year? Yes / No If yes, please give the date and amendment number for each substantial amendment made. 8. Serious breaches of the protocol or Good Clinical Practice Have any serious breaches of the protocol or GCP occurred in relation to this trial during the year? Under the Clinical Trials Regulations, all serious breaches must be notified to the MHRA GCP inspectors within 7 days of the matter coming to the sponsor’s attention. Yes / No If yes, please give the date of each notification to the MHRA. Please provide the REC with a copy of each notification for information (unless previously notified). 9. Other issues Are there any other developments in the trial that you wish to report to the Committee? Are there any ethical issues on which further advice is required? Yes / No Yes / No