Site Data Manager (SDM) benefits for CT Center

  • will reduce the time required for the Principal investigator/Co-investigator and the administrative burden =>
  • medical activities carried out in the visits, as required by the Protocol, can be given to =>
  • of these activities will be performed by a doctor clear detailed record in the source documentation, which will then be transcribed by SDM into eCRF / CRF =>
  • in case of doubt, the main problem with the Principal investigator/Co-investigator consulted before they had to make the same CT Monitor to the monitoring visits
  • in preparing answers to the Data Query/Data Clarification Form will be purely administrative questions answered/ready by SDM for signature Principal investigator/Co-investigator immediately
  • if necessary, tracing and expression expert medical opinion to a given query will be the Principal investigator/Co-investigator prepared documentation showing the source of the passage so that the Principal investigator/Co-investigator was forced to seek it and waste time
  • in the administration of additional queries in the SAE, the same support from the SDM as when responding to standard DCF
  • laboratory for answers to questions - see the same process
  • total time savings in the study will consider the possibility of participating in other clinical trials, because administratively will be 40% of the initial time required to perform learning tasks saved => ensures by Site Data Manager
  • better quality data from individual visits to the trial subjects registered in the source documentation

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