Information provided to subject - advertisement for Subject recruitment(if used) - any other documents given approval / favourable opinion - continuing review of trial (where required) 23 Regulatory authority(ies) authorisations / approvals / notifications where required for: - protocol amendment(s) and other documents To document compliance with applicable regulatory requirements · · · · 24 Curriculum vitae for new investigator(s) and / or sub- investigator(s) To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects · · · · 25 Updates to normal value(s) / range(s) for medical / laboratory / technical procedure(s) / test(s) included in the protocol To document normal values and ranges that are revised during the trial · · · N/A 26 Medical / laboratory / technical procedures / tests - certification or - accreditation or - established quality control and / or external quality assessment or - other validation (where required) To document that tests remain adequate throughout the trial period · · · N/A 27 Documentation of investigational product(s) and trial-related material shipment To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability · · · N/A Certificate(s) of analysis To document identity, purity, and N/A N/A
28 for new batches of investigational products strength of investigational product(s) to be used in the trial · · 29 Monitoring visit reports To document site visits by, and findings of, the monitor N/A · · N/A 30 Relevant communications other than site visits - letters - meeting notes - notes of telephone calls To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting · N/A · N/A 31 Signed informed consent forms To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (Original) (Copy) (Copy) N/A 32 Source documents To document the existence of the subject and substantiate integrity of trial data collected. To include original documents to the trials, to medical treatment, and history of subject (Original) (Copy) (Copy) N/A 33 Signed, dated and completed case report forms (CRF) To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject (Copy) (Copy) Copy) N/A 34 Documentation of CRF corrections To document all changes / additions or corrections made to CRFafter initial data were recorded (Original) (Copy) (Copy) N/A 35 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 · · · · 36 Notification by sponsor and/or investigator, where applicable, to regulatory authority(ies) and IEC(s) of unexpected Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IEC(s) of unexpected serious adverse drug reactions and of other safety · · · ·
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