Medical Research Management - FDA BIMO Inspection Preparation

Course Description

The FDA's Bioresearch Monitoring (BIMO) Program is an agency-wide system of inspections and data audits designed to monitor the conduct and quality of clinical studies at all levels — investigator sites, sponsors, pre-clinical laboratories and IRBs. Inspections may be planned or unannounced, so it is important to maintain inspection readiness at all times. This course is designed to guide monitors/auditors and investigator site personnel through the process of preparing for a BIMO inspection.

Course Objectives

Recognize the FDA Bioresearch Monitoring (BIMO) Program purpose.
Discuss type of inspections and what occurs at the investigator site versus sponsor level.
Describe the techniques and planning for BIMO inspection preparation.
Examine GCP issues and its management during BIMO inspection.

Daily Agenda / Course Topics

Day 1

The Bioresearch Monitoring Program-Objectives and Regulatory Background
Types of Inspections
Compliance Program Guidance Manuals
What to expect during a Sponsor/CRO and Investigator Inspection

Day 2

Provide a Preparation Plan and Tools/Techniques
Discuss GCP issues and management of them during the inspection.
Preparing for an Investigator Site Inspection
- Safety
- Deviations
- Investigator Product Accountability
- Regulatory Binder
Preparing for Sponsor/CRO Inspection
- Safety
- Deviations
- Monitoring
- Investigator Product Accountability
- Trial Master File

Who Should Take This Course

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.

Dates / Times / Accommodations

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)

Contact Hours

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 and Substitutions

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.