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Complete data collection and management system

  1. 1. CRO4Q Contract Research Organization Best Practice Copyright © 2013 Zeta Research S.r.l.
  2. 2. Case 2: Complete data collection and management system • Observational multi-centric trial on oncology Copyright © 2013 Zeta Research S.r.l. 2
  3. 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 Copyright © 2013 Zeta Research S.r.l. 3
  4. 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 Copyright © 2013 Zeta Research S.r.l. 4
  5. 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 : • • • • • 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 Copyright © 2013 Zeta Research S.r.l. 5
  6. 6. Case 2 Methods and tools • • • • • • • • • • • 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 Copyright © 2013 Zeta Research S.r.l. 6
  7. 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 Copyright © 2013 Zeta Research S.r.l. 7

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  • adelegn

    Nov. 23, 2020

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.

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