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Sharing of Data from Clinical Research Projects: Guidance from the SCTO’s Clinical Trial Unit Network
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Statistic and Methodology | Guidelines & Publications | Guideline
The guidance document provides practical recommendations for all relevant aspects of data sharing in accordance with legislation in Switzerland
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Site IMP-IMD Accountability Log
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Monitoring | Templates, Forms, and Quality Documents | Template
Tracks receipt, dispensing, and return of Investigational Medicinal Product/Device. Ensures accurate accountability at site level. Template & respective Instruction for use available for study coordinators.
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Site Initiation Visit (SIV) Agenda
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Monitoring | Templates, Forms, and Quality Documents | Template
Provides details of the SIV programme and the list of speakers. Template & respective Instruction for use available for monitors.
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Site Initiation Visit (SIV) Attendance Training Log
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Monitoring | Templates, Forms, and Quality Documents | Template
Lists the participants in the SIV and documents their initial training on the clinical trial documents. It is used (along with other documents) to verify that the site readiness and staff preparedness before trial start. Template & respective Instruction for use available for monitors.
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Site Training Log
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Monitoring | Templates, Forms, and Quality Documents | Template
Records training activities and qualifications of trial site personnel. Template & respective Instruction for use available for study coordinators.
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Sites Log Contact List
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Monitoring | Templates, Forms, and Quality Documents | Template
Template facilitates organised tracking of site staff. Template & respective Instruction for use available for study coordinators.
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Sponsor Delegation Log
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Monitoring | Templates, Forms, and Quality Documents | Template
Tracks delegation of trial-related duties from the Sponsor to authorized staff. Ensures accountability and compliance with GCP. Template & respective Instruction for use available for study coordinators.
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Sponsor Team Training Log
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Monitoring | Templates, Forms, and Quality Documents | Template
Records training activities and qualifications of Sponsor team personnel. Template & respective Instruction for use available for study coordinators.
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Statistical Analysis Plan (SAP) for Observational Studies
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Statistic and Methodology | Templates, Forms, and Quality Documents | Template
A standardized template for documenting the statistical analysis of observational studies.
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Statistics and Methodology - Github
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Statistic and Methodology | Technical Tools & Codes | R package & statistical code
SCTO GitHub, an online platform where all codes developed by the STAT Platform are stored This platform is for storing, sharing and collaborating on code.
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* Contains only tools and resources developed by the SCTO. SCTO CRC Network services are not included.