Course Offerings

The Research Triangle Park is world headquarters for clinical research activities. Become part of this vibrant industry by preparing to work as a clinical research monitor or clinical trials associate. This course covers the fundamentals of monitoring clinical trials, including the regulatory requirements for monitoring, how to conduct site visits, and how to report findings to sponsors.

Course Objectives

Compare and contrast types of monitoring visits

Cite ICH and FDA requirements for monitoring

Discuss the role of the monitor

List and discuss the essential documents collected at study startup

Describe the site activation process

Cite requirements for monitoring confirmation letters

Prepare a site monitoring plan

Review essential documents for regulatory compliance

Describe and discuss the informed consent process

Cite staff training requirements

Cite the requirements for safety reporting

Complete source data verification (SDV)

Compare and contrast source data verification and medical review

Assess adverse events and serious adverse events

Discuss investigational product (IP) accountability

Discuss remote monitoring fundamentals

Describe protocol deviations and reporting requirements

Discuss site communication requirements and techniques

Prepare for life on the road

Complete the practice monitoring visit

Write monitoring trip report and follow-up letter

Outline of Instruction

Introduction to Monitoring

Study Start Up

Conducting the Monitoring Visit

Reviewing the Regulatory Binder

Staff Training and Qualifications

Source Data Verification, Medical Review, and Informed Consent

Safety and Patient Protection

Investigational Product and Supplies

Principal Investigator Oversight

Remote Monitoring

Protocol Deviations and Violations

Clinical Team Structure and Communicating with Your Sites

Organizing Your Work - Your Life on the Road

Advancing Your Monitoring Skills and Training

Practice IMV visit

Contact Hours

96

CEUs

1

Industry Standard, State or National Certification

Certification

The Society of Clinical Research Associates, Inc

Website

www.socra.org

Certification Learning Outcomes/Requirements

Certified Clinical Research Professional (CCRP) exam is available for individuals who meet the following criteria:

-Have two years of experience as a full-time Clinical Research Professional (or have 3,500 hours part-time) during the last five years

-Hold a degree in "Clinical Research" from an Associate, Undergraduate, or Graduate Degree Program AND Have completed a minimum of one year of full-time experience (or 1,750 hours part-time) during the past two years as a Clinical Research Professional

-Hold an Undergraduate or Graduate Certificate in "Clinical Research" with a curriculum of no less than 12 semester (credit) hours or totaling a minimum of 144 credit hours from an academic institution of higher learning (community college, college or university) AND Hold an Associate's or Bachelor's Degree in a science, health science, pharmacy or related field AND Have completed a minimum of one year of full-time experience (or 1750 hours part-time) during the past two years as a Clinical Research Professional.

CE or CU Articulation

No

Prerequisites

Students must have taken CTR3110A3 Healthcare Clinical Research Specialist or have one year experience working in a Clinical Research setting as an associate or assistant

Learning Supplies Needed

Please see class 'details' for required textbook and/or supplies

Clinical Site/Special Facilities

n/a

Requirements for Successful Completion

90% attendance
Students must receive a minimum score of 80 on each exam

Accreditation/Special Approval Requirements

N/A

Intended Audience

This course is designed for individuals who have been working in the Clinical Research industry or have taken CTR3110A3 Healthcare Clinical Research Specialist and would like to further their knowledge and career path into Clinical Trial Monitoring

Specific Industry or Business Support Needs

Clinical Research Monitor
Clinical Research Associate

Wake County Need for Industry Positions

Wake County (RTP) is world headquarters for clinical research. A search on NC Works shows numerous Clinical Research Associate positions

Industry or Job Titles Related to Training Outcomes for Employment

Clinical Research Monitor

Clinical Research Associate

Related Courses

Course Contact Information

Health Science Non-Degree Programs https://cehealth.waketech.edu
919-747-0140
[email protected]