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 as well as adapt reporting structure as required. Reports will be prepared and completed to satisfy the clients needs. A final overall summary/presentation will also be provided (if requested).

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.

Current fees for auditing services will be discussed as appropriate.