Electronic Data Capture

Electronic Data Capture - MACRO

The data capture facility is supplemented with commercial data capture software supported by CICS: MACRO (InferMed, London, UK). On short term, this appears to be the only possibility of providing a validated GCP-compliant capture system. Independent of this effort, the German network is involved in ongoing collaborative projects with other networks to develop quality assurance methods for systems based on open source software components. This could help to reduce costs for investigator initiated trials in the future.

MACRO is a GCP-compliant, highly user-friendly electronic data collection solution for clinical research. The assessment and the decision for MACRO was based on the guidelines by TMF and the paper “Studiensoftware in den Koordinierungszentren für Klinische Studien (KKS): Status und Empfehlung für den Einsatz von Electronic Data Capture, W. Kuchinke et all“. One important feature was the online (web-based) or offline remote data entry facility.
Quality assurance procedures included installation qualification as well as training of CICS staff (system administrators and study designers)

Implementation of individual trials is available as service from CICS. Depending on the details of the trial protocol, in particular the number of named users involved, additional licensing costs need to be covered by the sponsors.

Further questions should be addressed to A. Fischer.

Electronic Data Capture - Implemented by IBE

A central electronic data capture facility has been implemented. The service is available to research groups within the consortium. It is suitable for repositories of medical data that do not require full GCP compliance. Restrictions apply to the use for clinical trial data in various Member States. This limitation may be overcome by supplementary methods of quality assurance of electronic records such as double data entry.

The requirements specification for a specific repository is a complex issue. Research groups interested in using a central data repository should allow ample time for this. The core of such a specification is the data dictionary for the repository. In order to facilitate this process, a data dictionary template is provided (see attached Excel document “D3.8 DataDictionary Template”).

Financial contributions by the groups may be required for the implementation of individual trials depending on the nature of the trial and the complexity of the data structures needed to implement the repository according to its specification.

Further questions should be addressed to A.Fischer.