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.
I. Overview of Monitoring and Preparation for the Case Studies
II. Case Study # 1:
III. Case Study # 2 – Applying Monitoring Technique and Tools
IV. Investigator Study File Review including the Regulatory reason and different SOP requirements
V. 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.
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.