CCBR conducts all clinical trial activities in compliance with ICH/GCP guidelines, the Clinical Trial Directive, relevant local regulations and guidelines as well as the clinical trial specific requirements. Additionally, CCBR employs a team of internal quality assurance auditors that regularly conduct internal audits to ensure the following:
Compliance with CCBR SOPs, ICH/GCP and FDA & EMA guidelines
Compliance with the clinical trial protocol procedures.
Investigational products are properly stored and maintained according to CCBR SOPs
Applicable laboratory procedures are properly documented and available including sample administration, equipment calibration logs, and service and maintenance records
Applicable clinic procedures are properly documented and available including equipment calibration logs and services and maintenance records
Complete training records, job descriptions, and curricula vitae (CV) for study personnel
Data consistencies between electronic and source documentation
Audits will be conducted according to internal audit plans that define the audit scope, required documentation, applicable SOPs and policies, and supporting documentation. All audit observations will be documented in an Audit Report. All audits are conducted by the CCBR Quality Assurance department as part of the CCBR Quality Management System. . In the event that CCBR is audited by Sponsors and /or third parties and/or inspected by the Regulatory Authorities, the assigned CCBR Quality Assurance Auditor will assist the site, as needed.
On a day-to-day basis, the Central Quality Assurance personnel, and also the Local Quality Control /Quality Assurance personnel play an important role in every day quality aspects at the sites.
Current quality status:
- Local Regulatory Authorities: 7 inspections so far resulting in no significant findings
- 20 - 25 Audits (Sponsors and/or third parties& Inspections per year
- There have been 3 FDA audits in CCBR:
- Denmark, Ballerup 1994
- Denmark, Ballerup 2006
- Denmark, Ballerup 2009
- There have been 2 EMEA (now EMA) audits in CCBR:
- Denmark, Aalborg 2008
- Brazil, Rio 2009
All FDA and EMA audits have been related to specific studies.