Data Review and Clarifications. A review of CRF data to the subject’s source data will be completed by the site monitor to ensure completeness and accuracy. After the CRFs have been completed, additional data clarifications and/or additions may be needed as a result of the data cleaning process. Data clarifications are documented and are part of each subject’s CRF.
Data Review and Clarifications. Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source data will be completed by the site monitor to ensure completeness and accuracy. Additional data clarifications and/or additions may be needed as a result of the data cleaning process. Data clarifications are documented and are part of each subject’s eCRFs.
Data Review and Clarifications. Targeted eCRF data will be reviewed against the subject’s source data by the study monitors according to the SDV plan to ensure completeness and accuracy. After monitoring has occurred at the clinical sites and the eCRFs have been submitted, additional data clarifications and/or additions may be needed. Data clarifications and/or additions are documented and are part of each subject’s eCRFs.
Data Review and Clarifications. Upon completion of the eCRFs, targeted data will be reviewed by the assigned Sponsor global clinical site management (CSM) team for accuracy and completeness. The planned source document verification and overall monitoring activities for this study are outlined in a separate document, the Protocol Monitoring Plan. Corrections and/or any necessary additions to the data will be applied and if required, queries will be generated. Designated investigative staff are expected to respond to data queries in a timely manner and ensure that the corrections and changes made to the data are reflected in the subjects’ source documentation. Deviations from this protocol, regulatory requirements and GCP must be recorded. An explanation of the deviation should be included, as applicable. In addition, corrective and preventive action should be identified, implemented and documented within the study records. Prior to study start, a plan for data validation will be completed by Alcon clinical data management, and agreed upon by the study clinical manager (CM) and other team members. Concomitant medications entered into the database will be coded using the WHO Drug Reference List. Medical history and adverse events will be coded using the medical dictionary for regulatory activities (MedDRA) terminology. Upon completion of the study and once the database is declared completed and accurate, the database will be locked and data will be available for data analysis. Any changes to the database after lock will be implemented upon agreement between the Sponsor’s clinical trial management, medical safety clinical data management and biostatistics departments, and will be completed following the Sponsor’s procedures for changes to a database after database lock.
