The Part 1 "Education" consists of a comprehensive online course covering chapters one through seven.

Course Details:

• Each student is provided with the online companion textbook and regulatory reference. This textbook correlates with the online course, allowing the student to view figures, illustrations, definitions, and flowcharts.
  
• The textbook is only available to MRM students.
  
• The online course is available at any time and completed at the students’ desired pace and schedule;
  
• Estimated completion time: 70-100 hours;
  
• Free Demo available.

The participant will be able to:

• Describe the medical product path starting with discovery and ending with marketing approval.
  
• Identify the GCP obligations in protecting the rights of study subjects.
  
• Distinguish the different roles and GCP obligations between the Investigator, Sponsor, and IRB.
  
• Explain the ‘ideal’ elements used in coordinating a clinical trial.
  
• Demonstrate the ability to perform monitoring and coordinating activities and detect GCP deficiencies.
  
• Choose the different problem-solving techniques in resolving GCP deficiencies.
  

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

• The Establishment of the Food and Drug Administration;
• The History of the Legislation and Regulations, which Govern the Clinical Research Process;
• The History of the Legislation and Regulations, which Protect the Rights, Safety, and Well-Being of Human Subjects.

2. Overview of Medicinal Product Research and Development

• Drug Discovery and Pre-Clinical Research;
• The Clinical Research and New Drug Application Approval Process;
• The Biologics Research, Development, and Licensing Process;
• Medical Device Research, Development, and Marketing.

3. Good Clinical Practice (GCP)

• Investigational New Drug Application 21 CFR 312: Sponsor’s Obligations;
• Investigational New Drug Application 21 CFR 312: Investigator’s Obligations;
• Institutional Review Boards 21 CFR 56;
• Protection of Human Subjects 21 CFR 50;
• Financial Disclosure 21 CFR 54.

4. International Conference of Harmonization

• The History of the International Conference of Harmonization;
• The ICH Good Clinical Practice Consolidated Guideline (E6);
• The ICH Clinical Safety Data Guideline (E2).

5. Clinical Trial Development

• Protocol Design and Development;
• Case Report Form Design and Development;
• Principals of Data Management and the Query Resolution Process;
• The Study Types Providing Expanded Access to Investigational Products.

6. Clinical Trial Management

    Investigator Site Perspective: Coordinating a Clinical Trial at the Site

• Essentials of Source Documentation;
• Maintaining and Managing Essential Documents;
• Recording and Reporting Non-Serious and Serious Adverse Events.

    Sponsor’s Perspective: Managing a Clinical Trial

• Selecting Investigators and Monitors;
• Maintaining and Managing Essential Documents (e.g. FDA Form 1572);
• Case Report Form Data Transmission and Generation of the Clinical Study Report;
• Reviewing and Reporting of Serious Unexpected Adverse Drug Experiences;
• Implementing a Monitoring Plan and Performing Quality Control.

7. Monitoring Obligations and Methods

• Monitoring Role and Responsibilities According to the FDA Guideline;
  
• Monitoring Role and Responsibilities According to ICH Good Clinical Practice Consolidated Guideline (E6);
  
• Monitoring Responsibilities: Type of Monitoring Visits, Monitoring Activities Pre-Visit, On-Site, and Post Visit;
  
• Monitoring Method: Implementing a Systematic Monitoring Approach to Effectively Monitor a Multi-Center Trial;
  
• Problem Solving and Trouble Shooting GCP / ICH Issues;
  
• Writing Strategic Monitoring Reports and Follow-Up Visit Letters.
  

"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 2 weeks 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 week one, a HRT Patch Study involving three subjects and the Investigator file is monitored. During week two, an OA tablet study involving two 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 two week training session. Students are provided report writing guidelines and are required to prepare a written report for review by the instructor.

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.

• Our Nationwide Course Locations;
  
• All classes: Two consecutive weeks, Monday thru Friday, 9:30 am – 5:30 pm;
  
• Comprehensive review of the Part 1 online course;
  
• Case studies simulating CRA activities;
  
• Course examinations and pre-exam review;
  
• Resume evaluation and career guidance;
  
• Prerequisite: Part 1 “Education” online course.

Criteria for Course Completion:

• Comprehensive cumulative examination with a minimum score of 70%.
  
• Perform monitoring competency testing identifying a minimum of 80% deficiencies.
  
• GCP Regulatory/ICH Guideline examination with a minimum score of 70%.

The candidate will receive a certificate of completion as a Clinical Research Professional and a certificate of recognition for passing the GCP/ICH examination.