corrections made to CRF after initial data were recorded Notification by originating Notification by originating X X investigator to sponsor of Investigator to Sponsor of Serious serious adverse events and Adverse Events and related related reports reports Notification by Sponsor and/or Notification by sponsor and/or X X X investigator, where applicable, Investigator, where applicable, to (where required) to regulatory authorities and Regulatory Authority(ies) and IRB(s)/IEC(s) of unexpected REC(s) of Unexpected Serious serious adverse drug reactions Adverse Drug Reactions (in and of other safety information CTIMPs: SUSARs) and of other safety information Notification by Sponsor to Notification by sponsor to X X Investigator of safety Investigators of safety information information. Final report by Investigator to X X To document completion of the trial REC where required, and where applicable, to the Regulatory Authority(ies) End of Study Declarations X X To document completion of the trial submitted to Authority and REC at the end of the trial Clinical Study Report To document results and X X X (if applicable) interpretation of trial 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
corrections made to CRF after initial data were recorded Notification by originating Investigator to Sponsor of Serious Adverse Events and related reports Notification by originating investigator to sponsor of serious adverse events and related reports X X Notification by Sponsor and/or Investigator, where applicable, to Regulatory Authority(ies) and REC(s) of Unexpected Serious Adverse Drug Reactions (in CTIMPs: SUSARs) and of other safety information Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions and of other safety information X (where required) X X 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 Study 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
UoB-CLN-QCD-002-Essential-Document-Checklist-CTIMPs-v--1-0-dd---15-Aug-2---.docx