ars® Investigator: (eCRF)

  • Checks and cross-checks on all variables according to the data management plan
  • Audit trail
  • Missing value list, of which entries can be worked off by clicking on the variable, jumping to the place where the value is missing and entering the value.
  • A "log" button appears beside each variable that has been changed. When the button is touched, type and time of changes are displayed.
  • Diagnoses, displayed in a drop down list, can be selected by the investigator and are automatically coded according to MedDRA (version 14.0 and later).
  • Drugs, displayed in a drop down list, can be selected by the investigator and are automatically coded according WHO-DRL.
  • In case of SAEs or ADRs .PDF files and .XML files according ICH E2B are automatically generated containing all patient data.
  • In case of SAEs or ADRs, e-mails are sent by the RDE system automatically to inform the personnel in charge (monitor and pharmacovigilance staff).
  • Complete logistics of the drug accountability is covered by the integrated module ars® Drug-Accountability.
  • Integrated system to see, to work off and to solve all queries of monitors, data managers and pharmacovigilance staff.
  • Automatic import of real time data from ars® Lab-Range according to units and normal ranges of local or central labs
  • Randomization of patients (central or local or mixed, stratified) will be automatically carried out by the RDE system, based on randomization lists, generated by SAS according to randomization requirements in advance and stored in the RDE database.
  • Daily import of recent lab data into the electronic patient files to be assessed by the investigator.
  • Electronic signature of all captured data by the investigator in charge.
  • Export of all captured data as “certified copy” according to the EMA requirements (.pdf data set).
  • Integrated interface between eCRF of the investigator and the module  ars® Patient e-Diary to monitor diary data of the patient (separate list of all days where data is missing)
  • Integrated interface between eCRF of the investigator and the module  ars® Patient e-Diary to export the patient diary data into a .pdf data set.
  • Time stamp utilities for all documents (local time, central time)
  • If requested, import or export of study data according to CDISC SDTM and CDISC ODM