Representatives from Cape Cod Clinical Research, Inc. will perform all Initiation, Routine Monitoring and Close-Out Visits per current Standard Operating Procedures and FDA regulations set forth in 21 CRF parts 50, 54, 56 and 312. The following is a summary of the tasks to be completed at each visit:

Initiation Visits:

Each site will be visited once prior to enrolling patients to complete an initiation visit. The following tasks will be completed:

• Review of investigational status of the drug.
• Review of the protocol with the Primary Investigator, Clinical Coordinator, Pharmacist and other members of the clinical staff as appropriate.
• All Sponsor and Primary Investigator responsibilities as outlined in 21 CFR Part 312.
• Review obligation of Primary Investigator to obtain written consent in compliance with 21 CFR Part 50.
• Review obligations of Primary Investigator to obtain IRB approval and to assure that the IRB is in compliance with 21 CFR Part 56.
• Review all study documentation, including the site's regulatory binder, documentation of serious adverse events, drug accountability forms and CRF's.

Periodic Routine Monitoring Reports:

Each site will be visited at regular time periods throughout the course of the study to ensure:

• The Primary Investigator is following the protocol and clinical plan as appropriate.
• The facilities remain adequate for the trial.
• The study staff remains adequate throughout the course of the trial.
• Changes to the protocol have been IRB approved.
• The site is keeping accurate and complete records, including patient medical and drug accountability records.
• The Primary Investigator continues to carry out the protocol required procedures, without delegating them to previously unidentified staff.
• The case report forms (CRF's) and corresponding source documents are complete, accurate and legible.
   Informed consent has been documented for each patient.

 Final Close-Out Visit:

A representative of Cape Cod Clinical Research, Inc. will visit each site, at the end of the trial; Inc will visit each location to perform a Final Close-Out Visit. Tasks to be completed at this time include (but are not limited to):

• Assuring that all clinical data has been retrieved, and all quires have been completed.
• Review of all regulatory documentation to assure its completeness.
• Assuring that the site's regulatory files are consistent with the master files.
• Review all investigational medication accountability, and assure that all study supplies have been returned or destroyed.
• Review the current record retention guidelines set forth in 21 CRF Part 312.
• Assuring that the Primary Investigator has provided the IRB with a final report.
• All site visits will be performed in compliance with the FDA's "Guideline for the Monitoring of Clinical Investigations."
   

Current fees for monitoring services will be discussed as appropriate.