ars^® Pharmacovigilance & ars Lab(-Range)

ars^® Pharmacovigilance:

• Integrated system, operating upon the data of the investigator, able to generate and track queries concerning incoming SAEs or ADRs to the monitor in charge to be clarified with the investigator.
• Initiated by data entry of a new AE, all actually existing patient data will be written into a .pdf data set that can be downloaded at any time.
• If an AE is modified by the investigator, the .pdf file will be renewed and can be downloaded as well.
• All responsible persons will be informed by the RDE system immediately by E-Mail if an AE is modified.
• In case of occurrence of a new or modification of an existing AE an ICH E2B .xml file will be generated automatically.
• If necessary the study data base can complemented (e.g. "expectedness?") by .csv data sets and fix update intervals.
  
  

ars^® Lab-Range:

• Integrated system, defining and (if necessary) modifying the lab variables, the units of the variables and the normal ranges (sex and age specific) for each variable, according to the corresponding central or decentral lab in the course of the trial. It is set up by two independent data managers (double data entry) and is administered by both, each one controlling and confirming actions of the other one.
• In case of announced changes of existing units or normal ranges in the course of the trial, these changes will be prepared, start date and start time of the changes will be set and will be started automatically, to ensure the correct checks of all lab variables in all centres at all times.

ars^® Lab:

• If a blood sample has been taken in a study centre the RDE systems automatically informs a company in charge for the transport (frozen or unfrozen sample) from the centre to the lab to pick up the sample in time.
• Daily (3.00 a.m.) automatical import of lab data from a central lab (or from several local labs) into the study database by the RDE system.
• In the course of the import logical checks are carried out to ensure the correctness of allocation of data to patients (e.g. in case of a permutation of lab requisition slips by a centre)
• Specific checks on lab values relevant according protocol (e.g. exclusion criteria) are performed automatically by the RDE system during the import
• Additional, RDE system initiated alert on the investigator’s screen if imported lab values are out of normal ranges
• Administration of MedDRA terms to be displayed as AEs in case of lab values out of range that are judged "clinically relevant" by the investigator