Online data collection systems, according to regulatory requirements for clinical data. Complementary data management tools (randomization, unblinding, AE registration, etc.) are through IWRS (Interactive Web Response System) and real-time data monitoring.

1. CRO4Q
Contract Research Organization
Best Practice
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2. Case 2:
Complete data collection and management system
• Observational multi-centric trial on oncology
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3. Case 2
Client:
Pharma multinational company with offices in several European countries and
a global distribution network.
Client’s aims:
Developing, testing and implementing an ad hoc complex system including:
•System for data collection
•Tool for entering and monitoring complementary data
for an observational multicenter oncology.
Specific advanced requirements:
•eCRF system according to the requirements for the collection of clinical data
•Web system to:
–collect additional data on patients’ flow of the facility
–calculation of statistical indexes on eCRF and entered data
–in real time monitoring of the study
–reference documents available
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4. Case 2
Proposed solution:
Development of a dual data management system:
1. e-CRF
2. Web site for additional required functions
eCRF system with the following features:
• widely shared and used worldwide in clinical trials
• constant updates and upgrades
• compliant with the requirements of functionality and security required to
meet standards on clinical data
• ad hoc checks on every field, operating in real time during data entry
• multiple levels of users and permissions
• log file data tracking
• electronic signature
• tools for monitoring and data source verification
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5. Case 2
Web site:
A web interface has been created with an interactive link with the eCRF
connecting different data bases, with masks for the data entry and retrieval of
records and documents, with the following features and functionality :
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three different levels of user: user, administrator, monitor
log file
uploading and viewing documents and newsletters
additional data entering on patient flow and more
Calculation of composite indicators merging the eCRF data base and
imputed data on the website
• Queries and tabular and graphical representations
• Graphics tailored to the specific requirements of the customer
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6. Case 2
Methods and tools
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Ad hoc development and programming of e-CRF
Implementation of specific checks on every field, operating in real time
Data base and data dictionary creation
SQL queries on eCRF data base for the extraction of data and indicators
required
Calculation functions and numeric output, tabular and graphical data
requirements
Development of a website with personalized architecture
User interface systems
Differentiation of access according to user level
Tools for monitoring
Real-time updating of data and queries output
Hosting, storage and maintenance
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7. Case 2
Client’s satisfied aims
• Ad hoc developed system in full compliance with the specifications
required by the customer
• Maximum optimization of all the tools and features
• Clear, optimized and user friendly functions
• Intreface and layout focused on objectives
• Great flexibility in the design phase of the system to changes required by
the client
• Compliance with clinical data safety requirements in all phases
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