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HRO Lunch Session Material - Successful paediatric HRO research projects: From feasibility to sampling, age-dependent design and date reuse
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Education & Training | Education & Training | Seminar
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Investigator Delegation Log
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Monitoring | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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 | Templates, Forms, and Quality Documents | Template
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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Online seminar: HRA ordinances - what has changed?
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Regulatory Affairs | Education & Training | Seminar
Presentation by swissmedic and Swissethic on the overview of the most significant changes in the new HRA ordinances in 2024 with a particular focus on the Clinical Trials Ordinance (ClinO) and Human Research Ordinance (HRO).
* Contains only tools and resources developed by the SCTO. SCTO CRC Network services are not included.