Auditing

CTCM performs audits regarding medical research involving human subjects at various levels: organizations, departments and studies.

Organization or department audit

We carry out a general audit of the quality assurance of clinical research for an entire organization or for a department. CTCM checks whether quality assurance is organized in accordance with applicable legislation and regulations (including the Dutch NFU guideline ‘quality assurance of research involving human subjects’, ICH-GCP, ISO14155). In advance you can indicate specific topics that you would like to see audited. 

Study audit

During a study audit, attention is also paid to the processes surrounding the conduct of a specific study.  

Rapporting and follow-up

After the audit, the findings are discussed with the auditees and an audit report is written describing the findings and recommendations. An audit report is often used by organizations as a baseline measurement for drawing up their own quality assurance policy and quality management system. If desired, CTCM can also provide support in setting this up.