The online Remote-Data-Entry- (RDE-) system ars®

The online RDE system ars® is built up in modules. It complies with the requirements of the FDA Guidance for Industry (2007) and supports all processes to carry out a clinical trial according to ICH/GCP guidelines.

According to study protocol and data management plan a plausibility checked electronic CRF, the module ars® Investigator is generated by the ars® Development Tool. ars® Investigator contains the module ars® Drug-Accountability as well.

The modules ars® Monitor, ars® Data Management and ars® Pharmacovigilance, that are working upon ars® Investigator and communicate with each other, are also generated by the ars® Development Tool.

If lab data have to be measured in the clinical trial the modules ars® Lab and ars® Lab-Range will be included as well. Units and normal ranges of the lab variables to be determined will be administered by ars® Lab-Range. The ars® Lab module carries out the daily import of lab data from the labs involved in the trial into the database of the RDE System.

In case a patient diary is required in the study, ars® Patient eDiary can be included in the set of RDE development tools as well to ensure that all patients can enter their diary data by an arbitrary internet device (PC, smart phone, tablet, etc.)

Access to all modules are given via SSL coded https web pages by using individual PINs and TANs.