SCTO Tools & Resources Navigator *
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Document Tracking List
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Monitoring | Document Management | Quality Documents
Templates facilitate organised tracking of essential trial documents and all site-related communications. Support compliance, transparency, and effective site management throughout the study. Template & respective Instruction for use available
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Guidelines for Risk-Based Monitoring
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Quality Management | Risk Management | Publications
These guidelines outline risk-based monitoring for clinical trials and help identify the appropriate monitoring risk category for each study.
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Investigator Delegation Log
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Monitoring | Human Research Act - HRA | Quality Documents
Tracks delegation of trial-related duties from the Investigator/Sponsor to authorised staff. Ensures accountability and compliance with GCP.
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Monitoring Close-Out Visit (COV) Report Template
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Monitoring | Human Research Act - HRA | Quality Documents
This template includes a step-by-step checklist for monitors and covers all the important aspects of a monitoring close-out visit.
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Monitoring Plan Template
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Monitoring | Study Management | Quality Documents
This template helps design monitoring plans aligned with Swiss and international standards, supporting risk-based strategies for clinical research.
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Monitoring Site Initiation Visit (SIV) Report Template
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Monitoring | Human Research Act - HRA | Quality Documents
This template includes a step-by-step checklist for monitors and covers all the important aspects of a site initiation visit.
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Monitoring Site Visit Log
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Monitoring | Human Research Act - HRA | Quality Documents
Log details of monitoring visits at the study site(s). Supports oversight and documentation of site interactions.
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Monitoring Visit Report Template
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Monitoring | Human Research Act - HRA | Quality Documents
This template includes a step-by-step checklist for monitors covering all the important aspects of a routine monitoring visit.
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Note to File- Deviation Log
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Monitoring | Human Research Act - HRA | Quality Documents
Documents protocol deviations and corrective actions. Provides rationale and context for trial irregularities for audit trails. Template & respective Instruction for use available
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Note to File-Deviation Form
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Monitoring | Human Research Act - HRA | Quality Documents
Documents protocol deviations and corrective actions. Provides rationale and context for trial irregularities for audit trails. 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.