Reports {List reports anticipated to be generated for this study in Table 3; examples are shown below. Additional reports that are agreed upon during the course of the study do not require an immediate amendment to the CDMP. Simply ensure that the final version of the CDMP (usually signed immediately prior to database lock) reflects all delivered reports.} Table 3. List of Data Management Reports Recipients/ Method for Report Name Description/Purpose Frequency Users Provision Medical Summaries of verbatim 1 month Medical Emailed zip file Coding Report and corresponding coded prior to DB Officer or AEs and ConMeds. For freeze for designee approval of medical DSMB coding, including split reports and events, preferred terms, prior to and System Organ database Class. lock. Query override Lists all queries where Monthly Data Automated report for EDC the data entry user Managers SAS report overrode the query with and other stored on local no change, includes the DM staff network. explanation for the change/DM review for acceptability of overrides.
Reports {List reports anticipated to be generated for this study in Table 3; examples are shown below. Additional reports that are agreed upon during the course of the study do not require an immediate amendment to the CDMP. Simply ensure that the final version of the CDMP (usually signed immediately prior to database lock) reflects all delivered reports.} Table 3. List of Data Management Reports Report Name Description/Purpose Frequency Recipients/ Users Method for Provision Medical Coding Report Summaries of verbatim and corresponding coded AEs and ConMeds. For approval of medical coding, including split events, preferred terms, and System Organ Class. 1 month prior to DB freeze for DSMB reports and prior to database lock. Medical Officer or designee Emailed zip file Query override report for EDC Lists all queries where the data entry user overrode the query with no change, includes the explanation for the change/DM review for acceptability of overrides. Monthly Data Managers and other DM staff Automated SAS report stored on local network.
clinical-data-management-plan-template_0.docx