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Extension of trial duration
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Administrative management of the grant
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* Time lag among centres for Ethics Board approval
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Start of the study only when all centres are ready
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* Difficulties in patients’ enrolment
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Administrative distinction between start-up/follow up (fixed) costs and “per patient” (variable) costs, with funds on variable costs allocated only to performing centres, based on periodic reports on patient enrolment and follow-up
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** Expanded recruitment time and length of the study
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** Insufficient statistical power; inclusion of additional centres; protocol amendments; lack of funds
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Lack of standardisation of operations
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Management support to Coordinator
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* Uneven execution of functional measurements between centres
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Clinical monitor support and good clinical practice compliance assessment
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* Unequal data quality and poor case report form maintenance
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Request for stronger coordinator management and training on outcome measures and data collection
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* Poor awareness of data protection principles
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Regular periodic meetings with the study steering committee
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** Clinical data provided by the centres not comparable
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Regular periodic reports to Telethon
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** Lack of secure centralised systems for data management
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Centralised IT platform available for patient registries and standard operating procedures for data sharing
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Centres’ over-commitment
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Rules of the grant applications
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* Lack of dedicated personnel
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Limitation in the number of active studies in which an investigator can participate
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* Overlap with routine clinical activities
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Cross-check of the number of staff full time equivalents reported in the applications
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** Inadequate number of professionals to ensure patient follow-up on schedule
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