CCCRI Services
AUDITING
Cape Cod Clinical Research, Inc. (CCCRI) will provide experienced auditors to perform audits in compliance with all current ICH/GCP regulations. Auditors from CCCRI will also adhere to all current in-house Standard Operating Procedures (SOPs) as well as adapt reporting structure as required. Reports will be prepared and completed to satisfy the needs of the client. If requested, a final overall summary/presentation will also be provided.
The audits will consist of the following areas:
- A brief introduction of the clinical program.
- A summary of the audit objectives for the site.
- An overall review of the study conduct.
- An in-house review of all regulatory documentation.
- An audit of all regulatory documentation in the site’s regulatory binder.
- Informed consent review for all patients who were screened for the trial.
- A review of all Investigational study drug accountability.
- A comparison of the source documents to their respective case report forms for approximately 20% of the patients at the site.
- A final summary, to include recommendations for process improvements.
CCCRI will be happy to further discuss your specific auditing service needs and thus develop a detailed project scope.
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