serious aderse drug information reactions and of other safety information 37 Notification by sponsor Notification by sponsor to to investigators of safety investigators of safety information · · · · information Interim or annual reports Interim or annual reports provided 38 to IEC and authority(ies) to IEC and to authority(ies) · · · · (Where (Where Subject screening log To document identification of · N/A required required) 39 subjects who entered pre-trial ) screening Subject identification To document that investigator / N/A 40 code list Institution keeps a confidential list · · · of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/ Institution to reveal identity of any subject Subject enrolment log To document chronological N/A 41 enrolment of subjects by trial · · · number Investigational products To document that investigational N/A 42 accountability at the site product(s) have been used · · · according to the protocol To document signatures and N/A 43 Signature sheet initials of all persons authorised to · · · make entries and / or corrections on CRFs N/A 44 Record of retained body To document location and · · · fluids/ tissue samples identification of retained samples (if any) if assays need to be repeated After Completion or Termination of the Trial
serious aderse drug reactions and of other safety information information 37 Notification by sponsor to investigators of safety information Notification by sponsor to investigators of safety information · · · · 38 Interim or annual reports to IEC and authority(ies) Interim or annual reports provided to IEC and to authority(ies) · · · · 39 Subject screening log To document identification of subjects who entered pre-trial screening · (Where required ) (Where required) N/A 40 Subject identification code list To document that investigator / Institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/ Institution to reveal identity of any subject · · · N/A 41 Subject enrolment log To document chronological enrolment of subjects by trial number · · · N/A 42 Investigational products accountability at the site To document that investigational product(s) have been used according to the protocol · · · N/A 43 Signature sheet To document signatures and initials of all persons authorised to make entries and / or corrections on CRFs · · · N/A 44 Record of retained body fluids/ tissue samples (if any) To document location and identification of retained samples if assays need to be repeated · · · N/A After Completion or Termination of the Trial
Essential_Documents_for_Conduct_of_Clinical_Trial_Checklist.docx