Purpose:
To insure DSI is in compliance with the Sponsor/CRA requirements for monitoring drug studies and maintain accurate, reliable data with respect to work place constraints. To insure that all relevant information from the monitoring visit is addressed. This procedure is intended to meet FDA Federal Regulations with respect to the International Conference on Harmonization-Good Clinical Practice process for clinical studies.

Procedures:

1. Monitors will be presented with this SOP. This letter is to assist them during and in planning for their monitoring visit.
2. Regular visits (usually every 4-6 weeks) will be performed as specified by the Sponsor or CRO. It is the responsibility of the Coordinator to document the date of this visit with all supporting staff.
3. The person(s) responsible for drug or test article accountability should be notified in advance about this visit.
4. A working location will be provided for the Monitor (room reserved by the Coordinator), with access to appropriate research staff. The hours of monitoring are from 7:00 am to 3:15 pm, Monday through Friday unless otherwise approved by the Project Manager.
5. During the monitoring visit the Research Coordinator with the help of the Research Assistant will provide all appropriate documents to the Monitor.
6. The Coordinators are responsible for working with the monitor from noon to the end of their working day so their schedule in seeing their subjects is not affected. Coordinators are responsible to see that the Monitors allocate time towards the end of their visit for an exit interview. Any issues that are needed to be resolved or clarified should be first addressed with the Coordinator. If issues are not clarified or it's beyond the scope of the Coordinator, it can be brought to the attention of the Project Manager.
7. Upon conclusion of the monitoring visit, the Monitor will confirm that a written summary of all clinical and regulatory finding will be sent to the respective Coordinator, with a copy to the Project Manager within two weeks.
8. The Coordinator is responsible for the resolution of the monitoring issues concerning clinical aspects of the study. The Coordinator must notify and review issues with the Project Manager when he /she feels any issue is beyond his/her scope of resolution.
9. The regulatory person which is the coordinator is responsible for resolving any regulatory issues of the monitoring visit.
10. A summary of the Monitor/s visit and any issues or resolution deemed necessary for further improvement for the site will be presented by the Coordinator at staff meetings and any required actions, if any, will be noted by the Project Manager, Director and Principal Investigator.
11. If the Monitor needs a meeting with the PI, they need to inform the Coordinator in their confirmation letter or at the beginning of their visit when and how long they need to meet with him. The issues to be addressed to the PI should pertain to any strong deviations noticed at the site after the Project Manager has been made aware and a reasonable amount of time has been given for the site to make corrections. General study update with the PI would be made possible only if the Monitor has informed the coordinator that such a meeting is desired beforehand.
12. The monitor should inform the Coordinator what her tentative plan is for conducting the monitoring visit if she is visiting for more than one day at the site, what documents she needs, etc. This can be done in the monitoring confirmation letter or in person when she visits the site on the first day. If sufficient notice is not given to retrieve certain reports which have been outsourced the site is not responsible for having this information ready at the time of the monitor visit.
13. The monitor will be shown our "Visiting CRA Welcome Page" at: www.DrugStudy.MD/CRA.html

Review & Revisions:
The Clinical Research Director and Project Manager will review this SOP annually, with advice being sought from the Principal Investigator. This SOP may be reviewed more frequently if the site staff reports that it does not reflect current operating procedures.

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCRI, CCRC, CCRP
PI (Principal Investigator), DSI (Drug Study Institute)
Board Certified Internist, JPMC (Jupiter Preventive Medicine Center)
DABIM (Diplomat American Board of Internal Medicine)
FACP (Fellow American College of Physicians)
CPI (Certified Physician Investigator) by the AAPP (American Academy of Pharmaceutical Physicians)
CCTI (Certified Clinical Trial Investigator) by the ACRP (Association of Clinical Research Professionals)
CCI (Certified Clinical Investigator) by the DIA (Drug Information Association)
CCRC (Certified Clinical Research Coordinator) by the ACRP (Association of Clinical Research Professionals)
CCRP (Certified Clinical Research Professional) by SoCRA (Society of Clinical Research Associates)
Founder, CertifiedResearchers.com
IRB Member, Jupiter Medical Center
Expert Medical Witness, ExpertMD