Execution

• Study initiation
• Keeping of the trial master file
• At data entry automatically precoding of diagnoses and adverse events by the RDE-System according to MedDRA coding rules (MedDRA versions 14.0 and later)
• At data entry automatically coding of drugs by the RDE-System according to WHO-DRL coding rules (WHO-Druglist is updated quarterly)
• Each night automatic import of lab data by the RDE-System into the RDE database
• Monitoring and (if necessary) modification of normal ranges according to central or decentral labs
• RDE based remote and onsite monitoring according to ICH/GCP requirements (instant benefit : time reduction of onsite monitoring up to 80 % compared to monitoring of paper CRFs)
• Permanent check on completeness and plausibility of patient/subject data
• Drug accountability
• Administration of remuneration of the investigators
• Interim analyses (if planned or amended) and analyses for the DSMB according to study protocol
• Instant collection, reporting and discussion with sponsor and principle investigator in case of SAEs or severe ADRs (Safety Monitoring) - automatic information to the pharmacovigilance by e-mail
• Hotline for the RDE system and trouble ticketing