SCTO Tools & Resources Navigator *
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Participant AE Log
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Monitoring | Human Research Act - HRA | Quality Documents
Logs all reported adverse events experienced by participants. Aids in safety monitoring and regulatory reporting.
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Participant Identification Log
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Monitoring | Human Research Act - HRA | Quality Documents
Tracks participant screening outcomes, enrolment status, and identifiers. Supports recruitment tracking and subject confidentiality. Template & respective Instruction for use available
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Participant IMP-IMD Accountability Log
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Monitoring | Human Research Act - HRA | Quality Documents
Tracks receipt, dispensing, and return of Investigational Medicinal Product/Device. Ensures accurate accountability at both site and participant levels. Template & respective Instruction for use available
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Position Paper: Central Data Monitoring in Clinical Trials
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Monitoring | Human Research Act - HRA | Publications
This fact sheet explores central data monitoring (CDM), its role in data quality and oversight, and clarifies terminology and guidance for implementation
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Position paper: Monitoring in Non-Interventional Human Research Projects
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Monitoring | Human Research Act - HRA | Publications
This position paper offers recommendations for monitoring strategies in non-interventional studies, from new data collection to reuse of clinical data or samples
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Risk-Based Monitoring Score Calculator
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Quality Management | Risk Management | Risk Score Calculator
This interactive tool helps research teams assess monitoring needs, generate RBM scores, and ensure efficient, high-quality trial oversight.
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Routine Monitoring Visit and Close-Out Visit (RMV-COV) Report Template
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Monitoring | Human Research Act - HRA | Quality Documents
This up-to-date and user-friendly monitoring template can be used to report a combined routine monitoring visit and monitoring close-out visit.
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Screening & Enrolment & Identification Log
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Monitoring | Human Research Act - HRA | Quality Documents
Tracks participant screening outcomes, enrolment status, and identifiers. Supports recruitment tracking and subject confidentiality. Template & respective Instruction for use available
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Screening & Enrolment Log
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Monitoring | Human Research Act - HRA | Quality Documents
Tracks participant screening outcomes, enrolment status, and identifiers. Supports recruitment tracking and subject confidentiality. Template & respective Instruction for use available"
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Site IMP-IMD Accountability Log
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Monitoring | Human Research Act - HRA | Quality Documents
Tracks receipt, dispensing, and return of Investigational Medicinal Product/Device. Ensures accurate accountability at both site and participant levels. Template & respective Instruction for use available
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* Contains only tools and resources developed by the SCTO. SCTO CRC Network services are not included.