This three-day seminar is the starting point for quality monitoring. MRM’s 3-step monitoring method is a systematic approach that includes the CRA’s organization and application of methods to facilitate standardization and assessment, complying with GCP, ICH, and HIPAA. Developing monitoring skills involves learning valuable time management tips and acquiring tools that facilitate consistency in performing the responsibilities of a CRA. This course is enhanced by the hands-on training that utilizes simulated case studies, and an investigator study file. 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

• The 2016 ICH GCP Addendum and how it affects monitoring practice
• Verifying informed consent GCP compliance and medical record audit using the MRM Step Method™.
• Current industry practice on the use of source worksheets and applying the ALCOHA standard.
• Using monitoring tools for systematic review of AEs/SAEs, deviations and action items
• Developing CAPA plans to address GCP non-compliance and determining when escalation is required

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

• 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. Queries and Action Items

• Writing effective queries and action items

This course is designed for individuals with a minimum of 6 months clinical research experience or CRAs who have not had any formal training and want to learn skills that will enhance their monitoring activities.

Seminar Dates	Seminar Location	Seminar Time	Seminar Fees
Register by Phone: 877-633-3322 OR Print Application (pdf) and Fax To: 954-346-2791		Accommodations 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.