TELLING THE INSIDE STORY- ACTIVITY AND PERFORMANCE METRICS FOR A TYPICAL INTERNATIONAL MULTI-LANGUAGE MULTI-CENTER NON-INTERVENTIONAL STUDY WITH THE INTRIAL DATA CAPATURE SYSTEM

Author(s)

Eichmann F*1;Hausner S1;Schwunk M1;Faber S1, Potthoff P2 1Kantar Health Germany, Munich, Germany, 2Kantar Health GmbH, München, Germany

OBJECTIVES: Getting insight into the technical and logistical challenges of a typical global non-interventional EDC study by analyzing the pure log file numbers: from application scalability to data handling and processing. METHODS: To analyze EDC activity and performance metrics, a global oncological observational study managed via the INTrial EDC application was selected.  System log files were used for quantitative and qualitative performance/workflow-related aspects and time measurements. RESULTS: Study parameters: The study ran for 4 years and was conducted in 39 countries with 6 languages, 382 sites, 3395 patients and 1612 users. The electronic Case Report Form for a single patient consisted of up to 2513 fields with a total number of 1,574,627 filled-in fields for the whole study. 24,382 translations were imported into the EDC system. Using 845 possible system queries per patient, 163,703 of these were commented and resolved, 30,451 manual queries were inserted. In total, 4,938,215 page calls took place for reading purpose and 582,052 for writing purpose (average of 3,781 page calls per day, 2.6 calls per minute).  6,060,981 field entries or changes (value or status) were carried out (average:  4,151 changes per day). Performance:  Time between real data collection and data entry by site: 25% within 5 days, 22% from 6 to 20 days and 24% from 21 to 60 days. 92% of all manual queries had been commented by the site. Average time for resolving site comments for system queries: 29 days. Average time for translation processing: 19 days. CONCLUSIONS: A suitable technical system like INTrial can help to improve and optimize the study workflows.  Easy to use data entry and data management functionalities and additional tools like multi language support, translation import or archiving are substantial – always in combination with a well trained and enthusiastic study team and established procedures.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PRM57

Topic

Real World Data & Information Systems

Topic Subcategory

Reproducibility & Replicability

Disease

Multiple Diseases

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