ars^® Monitor & ars^® Data Management

ars^® Monitor:

• Daily remote monitoring of incoming patient data. Queries to investigators and study nurses can be sent and asked permanently.
• Onsite monitoring with complete information on missing and unclear patient data in the trial centre
• Complete documentation of the monitoring visit including a monitoring audit trail to achieve an automatic drawing-up of one part of the monitoring report.
• Source data verification of all patient data, generated by the investigator outside the eCRF first, will be automatically assigned to the corresponding monitoring visit. All patient data entered by the investigator directly into the eCRF according to protocol will be "Source Data" according to GCP guidelines.
• Generation of .pdf data sets containing the general documentation of the visit, documentation on source data verification and the audit trail of the monitoring visit after each monitoring visit as supplement to the monitoring report.
• Freezing of checked data that coincide with source data.
• Freezing of plausible source data.
• Automatic generation and tracking of queries for data that do not match with corresponding source data or for implausible data.
• Integrated query management system supporting discussions with the investigator and his team on each query (message system).
• Integrated system to work off and to solve queries from the data management and from the pharmacovigilance
• Defreezing of frozen checked data if it incorrect source data is brought to attention.

ars^® Data Management:

• Integrated system operating upon the frozen data of the investigator. It allows the marking of variables, the generation and tracking of queries to the monitor in charge for clarification with the investigator 
• Contains a system to build up .CSV files of lists of values of arbitrary variables from all patients
• Ability to export recruitment and status data to external information systems daily.