Notification by Sponsor to Notification by sponsor to X X Investigators of safety information Investigator of safety information. Final report by Investigator to To document completion of the X X REC where required, and where trial applicable, to the Regulatory Authority(ies) End of Study Declarations To document completion of the X X submitted to Authority and REC at trial the end of the trial Clinical Report To document results and X (if X X interpretation of trial applicable) Notes: * Many non-commercial trials use pharmacy supplies of medicinal products that have a marketing authorisation and the tracking of product batches, shipping conditions and accountability, storage and dispensing instructions and the need for reconciliation between medicinal products supplied, used and returned before destruction as well as the process for destruction will be part of the pharmacy’s standard operating procedures for handling clinical trial materials. If this applies, provided the pharmacy SOP conforms to the applicable legislation and guidance, including retention of records, it may be noted in the TMF and ISF. Columns marked the underlying processes are dealt with by the UoB central offices (Research Governance Team, Research Finance Office) and the ‘X (auto)’: information will be automatically captured in the Sponsor Files. References
Notification by Sponsor to Investigators of safety information Notification by sponsor to Investigator of safety information. X X Final report by Investigator to REC where required, and where applicable, to the Regulatory Authority(ies) To document completion of the trial X X End of Study Declarations submitted to Authority and REC at the end of the trial To document completion of the trial X X Clinical Report To document results and interpretation of trial X (if applicable) X X Notes: * Many non-commercial trials use pharmacy supplies of medicinal products that have a marketing authorisation and the tracking of product batches, shipping conditions and accountability, storage and dispensing instructions and the need for reconciliation between medicinal products supplied, used and returned before destruction as well as the process for destruction will be part of the pharmacy’s standard operating procedures for handling clinical trial materials. If this applies, provided the pharmacy SOP conforms to the applicable legislation and guidance, including retention of records, it may be noted in the TMF and ISF. Columns marked ‘X (auto)’: the underlying processes are dealt with by the UoB central offices (Research Governance Team, Research Finance Office) and the information will be automatically captured in the Sponsor Files. References