Ethical documentation, data and site management

CRO4QContract Research Organization

Best practice

Copyright © 2013 Zeta Research S.r.l.

Case 3: Ethical documentation, data and site

management

• Randomized pediatric pre-market trial on Medical Device

2Copyright © 2013 Zeta Research S.r.l.


Client:Medical Devices producer with an international distribution network.

Client’s aims:Managing the process of ethical submission and approval of the study, development of data collection tools, data management, monitoring ,for a pre-market Pediatric Medical Device (class II) trial.

Specific advanced requirements: Clinical protocol revision Drafting of documents for the Ethical Commitee Initiation site visit Site file Monitoring Project management

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Proposed solution:

• Methodological and statistical review of the research project from a draft of the clinical trial protocol

• Preparation of a technical report on the product based on available technical, scientific and pre-clinical data

• Ethical documentation drafting and management• Management of the process of submission to IEC until approval• Writing ad-hoc e-CRF (Electronic Case Report Form) optimized

following the end points• Initiation site visit, investigators’ training• Monitoring visits with senior monitor (according to legal

requirements)• Final statistical analysis and reporting

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Methods and tools:

• Scientific literature research and review and pre-clinical and clinical data analysis for the protocol protocol and technical report writing

• Drafting of documents for the Ethical Commitee• Management of the process of submission to IEC until approval• Projecting and implementazion of a web-based data collection

system (online) for e-CRF (according to legal requirements)• Implementation of a system IWRS (Interactive Web Response

System) to manage randomization, unblinding, device deficiency, adverse event recording

Case 3

Copyright © 2013 Zeta Research S.r.l. 5


Methods and tools:

• Training on protocol, experimental device and data collection tools for investigators

• Site monitoring: initiation site visit, monitoring and study closure performed by Senior Monitor in possession of all the legal requirements

• Drafting of all documentation to be included in the Site File available to the authorities

• Project management to support the Centre and its activities, and to interface with the Promoter

• Data analysis performed by the internal biostatistician team• Planning and writing of the Clinical and Statistical final report • Full compliance to Good Clinical Practice and to the ISO 14155

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Client’s satisfied aims

Case 3

•Added value derived from the Project Management: assistance and support to the Centre for operational and organizational needs in the start up phase of the study

• Optimization of the internal resources of the client.

•Clear reporting and effective in full compliance with the goals set by the client.

•Ready-to-spend data according to the client’s scientific and market objectives.

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Ethical documentation, data and site management

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