Investigator to Sponsor of Serious serious adverse events and related reports Adverse Events and related 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 and of and of other safety information 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 To document completion of X X the study REC where required, and where applicable, to the Regulatory Authority(ies) End of Study Declarations X X To document completion of the study submitted to Authority and REC at the end of the study Clinical Study Report To document results and X X X (if applicable) interpretation of study Notes: the underlying processes are dealt with by the UoB central offices (Research Governance Team, Research Finance Office) and the Columns marked ‘X (auto)’: information will be automatically captured in the Sponsor Files.
Investigator to Sponsor of Serious Adverse Events and related reports serious adverse events and related reports Notification by Sponsor and/or Investigator, where applicable, to Regulatory Authority(ies) and REC(s) of Unexpected Serious Adverse Drug Reactions 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 study X X End of Study Declarations submitted to Authority and REC at the end of the study To document completion of the study X X Clinical Study Report To document results and interpretation of study X (if applicable) X X Notes: 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.
Essential-Document-Checklist-non-CTIMPs-v--1.docx