The starting point in creating a quality monitoring process is using a systematic approach. This course trains the CRA on MRM's three step monitoring method to facilitate consistency and standardization in performing the monitoring responsibilities. Another important aspect of monitoring is learning how to bring a non-compliant investigator into compliance using Corrective Action and Preventative Action (CAPA) plans and documenting such plans in a professional and effective monitoring report and follow-up visit correspondence. This 3 day course is enhanced by the hands-on training that utilizes simulated case studies, an investigator study file, and report writing exercises. These techniques can be applied to all studies whether they are drug, device, or biologic.

• Identify the methods used in Source Documentation Verification (SDV).
• Discuss the monitoring activities involved with investigational medicinal product accountability.
• Review the criteria used to validate the Research Authorization and Informed Consent Form.
• Recognize the documentation used to demonstrate monitoring activities.

Day 1

I. Overview of Monitoring and Preparation for the Case Studies

• Monitoring Obligation and Purpose
• General Monitoring Plan Content
• Three-Step Monitoring Method/Technique, Tools, and Organization
• Developing Corrective and Preventative Action Plans (CAPA) for GCP ICH non-compliance
• Monitor preparation prior to a site visit
• Setting up the Monitoring file system
• Protocol and CRF Review for Case Study Exercises on Day 2 and Day 3

Day 2

II. Case Study # 1

• Applying Monitoring Technique and Tools
• Monitor SV1, SV2, V1, AEs, and CC meds
• Case Study # 1 – Review and Discussion of Deficiencies, Remedies, and Prevention (CAPA)

III. Case Study # 2

• Applying Monitoring Technique and Tools
• Monitor SV1, SV2, V1, AEs, and CC meds
• Case Study #2 – Review and Discussion of Deficiencies, Remedies, and Prevention (CAPA)
• Potential Issue/Problem Exercise

Day 3

IV. Investigator Study File Review including the Regulatory reason and different SOP requirements

• ISF Case Study – Monitoring
• ISF Case Study – Review and Discussion of Deficiencies, Remedies, and Prevention

V. Monitor Report and Follow-up Letter

• Content “What goes in a report” and Writing Style
• Writing Reports using the CAPA style (Corrective Action and Preventative Action) to document the securing of compliance

This course is designed for individuals with a minimum of 6 months clinical research experience. CRAs that do not have formal training, but are interested in learning skills that will enhance their monitoring activities and those who are transitioning into a CRA position will benefit from this course.

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
August 23-25, 2007	Coral Springs, FL	9 AM - 4 PM	$1195.00 (15% discount for 3 or more)
September 20-22, 2007	Chicago, IL	9 AM - 4 PM	$1195.00 (15% discount for 3 or more)
December 6-8, 2007	Princeton, NJ	9 AM - 4 PM	$1195.00 (15% discount for 3 or more)
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-603-0560		Coral Springs Accommodations: Coral Springs Marriott Ask About Student Discount (Availability limited)

Florida State Provider #50-11408, Provider approved by the California Board of Registered Nursing, Provider #CEP 13617 for 16.5 contact hours. Credits can be applied to ACRP certification.

Cancellations by registrants must be provided in writing prior to the start date of the seminar, such registrants shall receive a credit voucher toward a future MRM seminar. Companies may substitute someone registered with another participant at any time. MRM reserves the right to cancel a seminar due to poor enrollment or acts of nature and shall not be responsible for any airfare, hotel, or other costs. MRM shall offer a credit voucher to a future seminar or a complete refund for MRM Seminar cancellations. Seminar topics and speakers may be subject to change without any prior notice.