Silvertree BioLife's Investigator Site Audits provide a thorough evaluation of clinical trial site compliance with protocols, ICH GCP Guidelines, regulatory standards, and SOPs. These audits help ensure regulatory alignment, uphold data integrity, and mitigate risks, supporting sites in maintaining the highest standards of trial conduct.
Summary of Scope
Our comprehensive audits cover every aspect critical to trial compliance:
- Study Conduct: Protocol & Regulatory Adherence. Ensuring compliance with FDA and Health Canada regulations, ICH GCP Guidelines, and study protocol requirements. This includes verifying that the study is conducted according to the approved protocol, investigator oversight is maintained, IRB approvals are current, and all regulatory obligations are met throughout the trial lifecycle.
- Participant Safety, Data Integrity & Data Quality. Ensuring the protection of participant rights, safety, and well-being through robust informed consent processes and ethical oversight. Verifying data integrity and data quality (ALCOA++) by assessing source documentation, data recording practices, and ensuring accuracy, completeness, and consistency of clinical data. Where applicable, evaluating blinding controls to maintain the integrity of study results.
- Operational Excellence. Ensuring streamlined site operations by reviewing site personnel qualifications, training records, delegation of duties, investigational product (IP) management, equipment maintenance, and essential document management for accuracy and completeness. Additionally, assessing the adequacy of site-specific Standard Operating Procedures (SOPs) to ensure alignment with GCP requirements and regulatory standards.
- Site Management & Clinical Monitoring. Evaluating the effectiveness of site management practices and clinical monitoring activities to ensure protocol compliance, data integrity, and participant safety. This includes reviewing site communication, monitoring visit reports, follow-up actions, and the ability of CROs to maintain consistent compliance and accountability throughout the trial lifecycle.
Key Components of our Site Audits:
- Pre-Audit Consultation: A tailored consultation to understand the sponsor's objectives, study scope, and regulatory obligations, setting the foundation for an audit that precisely addresses critical compliance areas.
- Investigator Site Audit: A comprehensive onsite audit, including meetings with the Investigator and site personnel, facility tour, review source documents, essential documents and site procedures. We evaluate adherence to the study protocol, regulatory requirements, GCP standards, and overall compliance.
- Trial Master File (TMF) Review: A thorough review of the TMF to verify that all essential documents are complete, accurate, and reflect current site status.
- Audit Report and Remediation: Delivery of clear, actionable audit report that outline findings, detailed feedback, and recommended action plans to reinforce compliance practices.
Schedule a GCP Audit Consultation by emailing us at contact@silvertreebiolife.com.
