| Daily Routine Support for Study Management and Monitoring by a Clear Application with an Intelligent Data Model Georg Zimmera and Irina Grünertb Zimmer + Frischemeyer GmbHa, Organisation · Information · Kommunikation, Langenfeld (Germany), and Medical Affairs Ortho Biotech, Janssen Cilag GmbHb, Neuss (Germany)
An efficient and qualified execution of clinical trials equally needs medical proficiency and process know how. A lot of administrative tasks concerning site selection, initiation, supply, monitoring and closure have to be performed, independently from the procedures of patient data capture.
The study management staff has to carry out and track hundreds of single tasks and it is very hard to keep the overview, meet the timelines and additionally guarantee the regulatory compliance according to GCP (Good Clinical Practice) by a transparent and comprehensible documentation.
Standard software applications usually do not support the daily routine, they are very expensive and they offer poor customising possibilities and flexibility. The latter is necessary because clinical trials differ in design, procedures and required quality standards.
For that reason small and handy Microsoft Access® applications have been setup to support the study management daily routine. These study databases are not limited to medium-sized companies but can also be found within affiliates of international corporations.
These Access applications usually run in the responsibility of the clinical research or medical affairs department. They have been developed from the pure data view and organicly grown in course of time. New features have been added, others have been adapted several times. The systems are often completed by various Microsoft Excel® sheets and Microsoft Word® lists for different purposes.
The objective of the project described in the following article was to replace several existing study databases and various additional worksheets and checklists with many manual interfaces by a new designed process-oriented study management application. The existing import routine of study-, center- and patient data from the leading central Clinical Information Management System (CIMS) for corporate trials had to be continued.
The following concrete case shows, how to set up an efficient and transparent study management application based on standard office tools supporting the day-to-day business of study managers and assistants as well as internal and external monitors.
The metrics of success have been a process-oriented approach, an intelligent data model and clear application interfaces.
The concrete case contains many independent modules like address administration, contact history, investigator fee accounting or medication tracking including the logic links to the study-, center- and patient data, which easily can be adapted to other applications in other departments and companies.
Key words Clinical data management • Clinical trial, contact management, data model, investigator accounting, monitoring • Study management |
