"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.