GCP Audits

Clinical Research Consulting and GCP Auditing Services

The FDA issued a press statement in August 2009, detailing plans to clamp down on non-compliant investigators and enhance its debarment and disqualification measures. According to OutsourcingPharma.com, the number of FDA warning letters to clinical trial investigators has increased by 50% in 2009 as a consequence of improved processes at Division of Scientific Investigations (DSI).

Polaris performs GCP audits of both domestic and international sites in the following areas:

Vendor Qualification GCP Audits

• Evaluate clinical sites and facilities
• Assess the qualifications of CRO and other third party vendors
• Assess EDC and IVRS systems
• Assess Vendor Certification programs
• Assess qualification and training of personnel
• Review organizational structure and SOP content
• Inspect clinical laboratory facilities

GCP Auditing of Investigators/Study Sites

• Inspect site facilities and equipment
• Assess compliance with FDA regulations and guidelines, International Conference on Harmonization (ICH) guidelines, the sponsor/CRO’s SOPs, and the protocol
• Review records and procedures concerning interactions with the IRB
• Review records and procedures concerning test article accountability, Adverse Event (AE) reporting, human subject protections, and subject enrollment criteria
• Verify that data collected in Case Report Forms are supported by source documents

Sponsor / Contract Research Organization GCP Audits

• Verify that the protocol is performed according to applicable regulations, guidelines, and standards
• Review procedures for site visits and associated documents, such as monitoring reports and logs
• Review the qualifications and training of the CRO project team members
• Review the content of SOPs to ensure procedures and systems used in the conduct of clinical trials are in compliance with applicable guidelines and regulations, including SOPs for AE/SAE reporting, subject randomization, study supply distribution, clinical monitoring, and data handling
• Assess compliance with internal SOPs

Institutional Review Board GCP Audits

• Assess compliance with FDA regulations and ICH guidelines
• Review records and documentation of meetings and expedited review
• Evaluate the databases used to track SAEs and IND Safety Reports
• Review training records for IRB members
• Review the contents of SOPs
• Assess compliance with internal SOPs

GCP Inspection Readiness

• Prepare and conduct Mock Pre-Approval Inspection Audits
• Prepare personnel for inspector interviews

GCP Audits of Phase I Units

• Conduct specialized GCP auditing focusing on the issues associated with Phase I facilities
• Provide supporting Phase I training and SOP development

Why wait for an FDA inspection to find compliance issues or deficiencies in your clinical practices? By contacting Polaris today, you can ensure that your facility has properly implemented Good Clinical Practices procedures that FDA auditors will be looking for. Polaris is ready to assist you in understanding and implementing FDA GCP regulations and ICH guidelines via GCP auditing and training.