Up to date Subject Identification To permit identification of all X subjects enrolled in the trial by Code List investigator/institution in case follow-up is required. List should be kept in a confidential manner and for agreed upon time. Subject Enrolment Log To document chronological X enrolment of subjects by trial number Signed Informed Consent Forms To document that consent is X X (where obtained in accordance with applicable) GCP and protocol and prior to participation of each subject in trial. Also to document direct access permission Source Documents To document the existence of X the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject Sample Case Report Forms and To record trial related X X observations. any updates thereof Signed, and completed To document that the X X investigator or authorised Case Report Forms (CRF) (copy) (original) member of the investigator’s staff confirms the observations recorded Documentation of CRF To document all X X changes/additions or corrections (copy) (original)
Up to date Subject Identification Code List To permit identification of all subjects enrolled in the trial by investigator/institution in case follow-up is required. List should be kept in a confidential manner and for agreed upon time. X Subject Enrolment Log To document chronological enrolment of subjects by trial number X Signed Informed Consent Forms To document that consent is obtained in accordance with GCP and protocol and prior to participation of each subject in trial. Also to document direct access permission X X (where applicable) Source Documents 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 X Sample Case Report Forms and any updates thereof To record trial related observations. X X Signed, 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 X (copy) X (original)
UoB-CLN-QCD-002-Essential-Document-Checklist-CTIMPs-v--1-0-dd---15-Aug-2---.docx