QC2 offers the following GCP audits:
Investigator Site Audits
QC2 specializes in conducting audits of investigator sites and research centers to assess compliance with FDA Good Clinical Practices regulations, including 21 CFR Parts 50, 54, 56, and 312, FDA compliance programs, ICH guidelines, local regulations, and the study protocol(s). The adequacy of monitoring is also reviewed. Additionally, QC2 has special expertise in conducting audits of investigator sites worldwide.
Phase I Facility and Study Audits
QC2 conducts audits of Phase I studies to assess investigator conduct of the study and compliance with the study protocol, FDA Good Clinical Practices regulations, including 21 CFR Parts 50, 54, 56, 312, and 320, and ICH guidelines, and as applicable, local regulations . Phase I audits can include assessments of facilities, systems, and procedures, including computerized systems validation when applicable. Audits can also address the adequacy of monitoring.
Institutional Review Board (IRB) Audits
QC2 conducts audits of institutional review boards to assess their operations and the adequacy of documentation for compliance with Protection of Human Subjects and Institutional Review Board regulations (21 CFR Parts 50 and 56). Additionally, the responsiveness of the IRB to the sponsor’s needs is also reviewed.
Essential Documents/Trial Master File (TMF)/electronic TMF (eTMF) Audits
QC2 conducts audits of Trial Master File (TMF) and investigator site files to assess the organization and completeness of the records in accordance with 21 CFR Part 312, ICH Guidelines (ICH E6 Section 8.2), and protocol requirements.
Clinical Study Report (CSR) Audits
QC2 conducts audits of clinical study reports (CSRs). The audits include review of text, in-text tables and figures, and the synopsis to summary tables, figures, listings as applicable, protocol, statistical analysis plan, internal consistency, clarity of presentation, and consistency with ICH E3 – Structure and Content of Clinical Study Report.
