The Part 1 "Education" consists of a comprehensive online course covering chapters one through seven.
The participant will be able to:
The student must pass the test at the end of each chapter before advancing to the next chapter.
All seven chapters must be completed prior to attending the Part 2 "Hands-On" Training.
1. The Food and Drug Administration Past and Present
2. Overview of Medicinal Product Research and Development
3. Good Clinical Practice (GCP)
4. International Conference of Harmonization
5. Clinical Trial Development
6. Clinical Trial Management
Investigator Site Perspective: Coordinating a Clinical Trial at the Site
Sponsor’s Perspective: Managing a Clinical Trial
7. Monitoring Obligations and Methods
"Repetitio mater discendi"
Repetition is the mother of learning
Recognizing the value of learning through repetition and application of knowledge, the "Hands-On" Training course was created. Monitoring is a vital part of clinical research and requires a systematic approach to standardize the monitoring activities and yield quality data in an efficient timeframe. MRM provides 1 week of exposure to monitoring, applying our "3 Step Quality Monitoring Method SM". We train on "how to" monitor, "how to" write an efficient report, and "how to" interact with sites on a regular basis and with difficult issues.
The "Hands-On" was designed to provide exposure to different therapeutic areas, monitoring plans, source documents, Case Report Forms (CRFs), and Standard Operating Procedure Requirements (SOPs). Students receive a protocol, monitoring plan, and CRF completion guideline.
During the week, an HRT Patch Study involving three subjects and the Investigator file is monitored. Each case study is created using sophisticated GCP deficiencies. The level of sophistication and difficulty increases with each subject, allowing the student to gain exposure to a broad range of GCP issues.
The monitoring is followed by review and discussion, during which, deficiencies are identified. Using MRM's "Issue, Action, Follow-up, Results SM" report writing technique, ICH GCP action plans are presented to resolve the deficiencies and prevent their reoccurrence. The content, strategies, and importance of writing professional and effective reports is emphasized throughout the week training session.
Our experienced, professional instructors, in addition to their teaching responsibilities, actively monitor and manage research studies. By sharing with the students their commitment, experience, and passion for clinical research, they bring real-world knowledge into the classroom.
Topics covered include:
During the hands-on portion of the course, the candidate must successfully monitor three case studies and pass a Comprehensive Monitoring Competency and GCP Exam with a minimum score of 70%. The candidate will receive a certificate of completion to document his/her qualification as a Clinical Research Professional.
|Day 1 / Week 1||Day 2 / Week 1||Day 3 / Week 1||Day 4 / Week 1||Day 5 / Week 1|
|Review of Exam Study Guide and Key Points from the Online Education
The student is provided with the HRT Packet.
Key Content: HRT Protocol, Investigator's Brochure, and Clinical Monitoring Plan
|Monitor Training: HRT Protocol and Investigator's Brochure,
Clinical Monitoring Plan
Lecture: Monitoring Tools/Organization, and MRM's 3 Step Monitoring Method SM
Case Study #1 Monitoring
|Case Study # 1 Monitoring Continued
Case Study #2
|Case Study # 2 Monitoring Continued
Case Study #3
Review of Investigator File and Trial Master File Content
Monitor HRT Investigator File
|Comprehensive Monitoring Competency and GCP Exam
Exams are not reviewed in class