Risk Based Monitoring
The purpose of the Site initiation visit (SIV) is to ensure that the site is adequately prepared and equipped to conduct the study according to the protocol and regulatory requirements.
Key components of a Site Initiation Visit include:
Introduction and Training: The visit begins with an introduction of the study team members The purpose, objectives, and expectations of the trial are discussed. Training sessions are often conducted to ensure that the site staff fully understand the study protocol, procedures, and requirements.
Protocol Review: Detailed review and discussion of the study protocol, including inclusion/exclusion criteria, study procedures, data collection methods, and compliance requirements.
Regulatory Compliance: Verification that the site has obtained all necessary regulatory approvals, such as Institutional Review Board (IRB) or Ethics Committee approvals, and that the site staff is familiar with local regulatory requirements.
Study Procedures and Operations: Detailed discussions about the practical aspects of conducting the trial at the site. This includes the handling of investigational products, data collection methods, adverse event reporting, and ensuring the site’s infrastructure and capabilities meet the study’s needs.
Data Management and Recordkeeping: Review of data collection procedures, the completion of case report forms, and record-keeping requirements to ensure accurate and timely data collection and reporting.
Quality Control and Assurance: Emphasis on quality control measures and procedures, including the review of monitoring and auditing processes.
Communication Plan: Establishing clear lines of communication including reporting procedures for adverse events, protocol deviations, and other relevant study updates.
Site-Specific Requirements: Addressing any site-specific needs or concerns that may be unique to the study being conducted at that particular site.
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