Sample Case Report Forms and To record trial related X X any updates thereof observations. Signed, dated and completed To document that the investigator X X or authorised member of the Case Report Forms (CRF) (copy) (original) investigator’s staff confirms the observations recorded Documentation of CRF To document all X X corrections changes/additions or corrections (copy) (original) made to CRF initial data were recorded Analytical data and supporting To enable the conduct and X records relating to clinical trial quality of the data to be analysis evaluated to ensure that the research has been conducted in accordance with GCP and all applicable regulations. Notification by originating Notification by originating X X Investigator to Sponsor of Serious investigator to sponsor of serious Adverse Events and related adverse events and related reports reports Notification by Sponsor and/or Notification by sponsor and/or X X X Investigator, where applicable, to investigator, where applicable, to (where Regulatory Authority(ies) and regulatory authorities and required) REC(s) of Unexpected Serious IRB(s)/IEC(s) of unexpected Adverse Drug Reactions (in serious adverse drug reactions CTIMPs: SUSARs) and of other and of other safety information safety information
Sample Case Report Forms and any updates thereof To record trial related observations. X X Signed, dated and completed Case Report Forms (CRF) To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded X (copy) X (original) Documentation of CRF corrections To document all changes/additions or corrections made to CRF initial data were recorded X (copy) X (original) Analytical data and supporting records relating to clinical trial analysis To enable the conduct and quality of the data to be evaluated to ensure that the research has been conducted in accordance with GCP and all applicable regulations. X 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
UoB-CLN-ESD-QCD-001-Essential-Document-Checklist-CTIMPs-v.-2.0-dd01-Mar-2016.docx