Trial Management and Monitoring
We offer support in all aspects of the study implementation and ensure the monitoring of the processes. Close cooperation between the various departments ensures that the trial runs smoothly.
A study team is put together for each study project that we manage. Depending on the scope of the study, the team consists of one or more members from the fields of biometrics, data management, monitoring and drug safety. A project manager leads the study team within the ZKS. Our services include:
PROJECT MANAGEMENT
- Coordination of multicentre studies
- Monitoring of the data and material flow
- Reporting and documentation, newsletter
- Reporting for funding organisations, sponsors, authorities and ethics committees
- Maintenance of the Trial Master File
- Logistics of the investigational medicinal products
- Coordination of laboratory, pharmacy, reference centres
- Organisation of investigator meetings
- Preparation and submission of study protocol amendments
- Coordination of the activities of the Data Monitoring Committee
DATA MANAGEMENT AND IT
- Set-up and validation of databases
- Remote Data Entry (incl. training of study staff)
- Central Randomisation Service (Internet-based)
- Automatic plausibility, consistency and completeness checks
- Query Management
- Dunning and reminder system
CLINICAL MONITORING
- Risk-based Determination of the type and scope of monitoring
- On-site monitoring by ZKS staff
- Coordination of external monitors
SAFETY MANAGEMENT
- Creation of study-specific databases for serious adverse events (SAEs)
- SAE documentation, reporting and management including Safety Committee meetings
- Registration of serious adverse events (SAEs)
- Coding of adverse events (MedDRA)
- electronic reporting of suspected cases of serious adverse reactions (SUSAR reporting)
- preparation of the annual safety reports
BIOMETRICS
- Central and statistical monitoring
Contact person for the methodological section: E-Mail Adresse
SITE MANAGEMENT
The Site Management at the ZKS supports the study teams on site at the study centre in their tasks:
- Establishment and maintenance of a quality management system in the clinics of the Leipzig University Hospital
- Support in the preparation, monitoring and follow-up of internal and external audits and inspections
- Coordination and organisation of training courses and further education offers for the study staff
- Provision of study-relevant information to medical and non-medical study staff (courses and meetings, changes in regulations, etc.)
- Distribution of study relevant documents (e.g. certificates of proficiency tests, laboratory standard values)
- Support in the recruitment of trial participants
Contact for site management: E-Mail Adresse