GCP Audits

QC2 offers the following GCP audits:

Investigator Site Audits

QC2 specializes in 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, as applicable, local regulations, and the study protocol(s).  Adequacy of monitoring is also reviewed.  In addition, QC2 has special expertise in conducting audits of investigator sites throughout the world.

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 Audits

QC2 conducts audits of institutional review boards to assess their operations and adequacy of documentation for compliance with Protection of Human Subjects and Institutional Review Board regulations (21 CFR Parts 50 and 56).  In addition, the IRB’s responsiveness to the sponsor’s needs are also reviewed.

Essential Documents/Trial Master File (TMF) Audits

QC2 performs audits of sponsor and/or CRO held Trial Master File (TMF) and investigator site files to assess the organization and completeness of the records with respect to 21 CFR Part 312, ICH Guidelines (ICH E6 Section 8.2), and protocol requirements.

Electronic Trial Master File (eTMF) Audits

QC2 conducts audit of sponsor and/or CRO held electronic Trial Master File (eTMF) and investigator site files to assess organization and completeness of the records with respect to 21 CFR Part 312, ICH Guidelines (ICH E6 Section 8.2), and protocol requirements.

Data Listing Audits

For studies using paper-based data management, QC2 conducts verification of data listings to case report form entries and queries to determine database acceptance.  Audits of data listings to source data can also be conducted during the on-site audit.

Clinical Study Report Audit (CSR) Audits

QC2 offers audit services for clinical study reports (CSRs).  Audits include review of CSR main text (including in-text tables and figures) and synopsis for consistency with tables, figures, listings, protocol, and statistical analysis plan.  Logic checks, clarity of presentation, and consistency with ICH E3 –  Structure and Content of Clinical Study Report are also performed/assessed.

 

QC2 GCP audits are customized for your specific project and budget needs.  We can provide assistance with all aspects of your projects, including audit plan consulting and development; audit scheduling, conducting, and reporting, providing audit follow-up services (e.g., review of audit responses).  We can conduct both general qualification audits and in-study audits.