Data management {19}
ICH
Electronic case report forms (eCRF) will be created for each participant and all study data collected will be entered into the eCRF. Some data may still be captured entirely or partially on paper source documents and will manually be entered into the eCRF. Accuracy and completeness of the data will be checked by monitoring visits at each site, and by pre-programmed edit checks that will flag out of range values.Risk-based monitoring will be carried out according to the The sponsor will provide a framework for maintenance of quality in performance and reporting of laboratory procedures.The study database will be locked after the data has been monitored by the sponsor and all queries issued through data cleaning activities have been completed and resolutions documented.Essential documents will be retained until at least 2 years after the last approval of a marketing application in the International Conference on Harmonization (ICH) region and until there are no pending or contemplated marketing applications in an ICH region or at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product, or for not less than 10 years after trial completion, whichever is longer.These documents should be retained for a longer period, however, if required by the applicable regulatory requirements or by an agreement with the sponsor. It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained.