28 for new batches of strength of investigational · · investigational products product(s) to be used in the trial Monitoring visit reports To document site visits by, and N/A N/A 29 findings of, the monitor · · Relevant To document any agreements or N/A N/A 30 communications other significant discussions regarding · · than site visits trial administration, protocol - letters violations, trial conduct, adverse - meeting notes event (AE) reporting - notes of telephone calls (Original) (Copy) (Copy) 31 Signed informed consent To document that consent is forms obtained in accordance with GCP N/A and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (Original) (Copy) (Copy) Source documents To document the existence of the 32 subject and substantiate integrity N/A of trial data collected. To include original documents to the trials, to medical treatment, and history of subject Signed, dated and To document the existence of the (Copy) (Copy) Copy) N/A 33 completed case report subject and substantiate integrity forms (CRF) of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject (Original) (Copy) (Copy) Documentation of CRF To document all changes / N/A 34 corrections additions or corrections made to CRFafter initial data were recorded Notification by Notification by originating 35 originating investigator investigator to sponsor of serious · · · · to sponsor of serious adverse events and related adverse events and reports related reports Notification by sponsor Notification by sponsor and/or 36 and/or investigator, investigator, where applicable, to · · · · where applicable, to regulatory authorities and IEC(s) regulatory authority(ies) of unexpected serious adverse and IEC(s) of unexpected drug reactions and of other safety
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 · · · ·
Essential_Documents_for_Conduct_of_Clinical_Trial_Checklist.docx