Medical Monitor Certification I Medical Monitor Training
Advanced Physician Medical Monitor Certification (APMMC)™ Syllabus
CME Handout
Introduction to Clinical Research
What is ICH GCP
Code of Federal Regulations
CFR 21 Part 11
Sponsor/CRO Responsibilities
13 Principles, IRB, & Investigator Roles
Informed Consent
FREE PREVIEWSafety of Human Subjects in Clinical Research
FREE PREVIEWReporting Responsibilities of the Investigators
Adverse Events
Ethics of Research Involving Children
Ethics of Research Involving Mentally Incapacitated
FREE PREVIEWEthics of Research Involving Pregnant Women and Fetuses
Ethics of Research Involving Prisoners
Trial Management – Data Handling and Record Retention
a) Common Terminology Used In Clinical Research
b) Commonly Used Abbreviations and Terms in Clinical Research
ICH GCP Quiz
1. Duties and Responsibilities of a CRA/Medical Monitor
FREE PREVIEW2. Advanced Designs of Clinical Trials
3. Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)
4. Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)
5. Contract Research Organizations (Delegation, Responsibilities, Management )
6. Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)
7. Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)
8. Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)
9. Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)
10. Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"
11. Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)
12. Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)
13. Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)
14. Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)
15. Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)
Quality Monitoring Quiz Modules 1-15
16. Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)
17. Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)
18.The Clinical Trial Protocol - Advanced Mastery Review
19. Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)
20. Institutional Review Board (IRB)
FREE PREVIEW21. Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)
22. Data Safety Monitoring board- DSMB
23a. An Overview of Remote Monitoring
23b. An Overview of Remote Monitoring Video
24. Centralized Vs. Onsite Monitoring
25. Electronic Data Capture and Remote Data Capture Basics
26.Remote Monitoring of Clinical Trials and EMRs
27.Blinding in Clinical Trials
28. Communication between Blinded and Unblinded Staffsion
29.Investigational Product Storage and Dispensing
FREE PREVIEW30.Investigational Product Accountability in Clinical Trials
Quality Monitoring Quiz 16-30
31.Adverse Drug Reactions
32.Basics of Adverse Event Monitoring
33.Adverse Event Reporting
34.Risk Based Monitoring
35.Pharmacovigilance Part 1
FREE PREVIEW36.Pharmacovigilance - Part 2
FREE PREVIEW37.Safety Reporting Requirements for Sponsor Investigators of An IND
38.Investigator Initiated Multi-Center Trials
39.IND and NDA Process
40.Guidelines for Designing and Completing Case Report Forms
FREE PREVIEW41. Do’s and Don’ts of a Case Report Form Design
42.Introduction to the Bioresearch Monitoring Program (BIMO)
FREE PREVIEW43. Clinical Trial Management System-CTMS
FREE PREVIEW44.Minimizing Source Data Queries In Clinical Trials
Quality Monitoring Quiz 31-45
45. Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)
1.Regulatory Documents in Clinical Research
2.Regulatory Affairs
3. Essential Regulatory Documents Guidance and Binder Tabs (Part 1)
4. Essential Regulatory Documents Guidance and Binder Tabs (Part 2)
5. Electronic Regulatory Submission and Review
6.Financial Disclosure- Duties and Strategies for Clinical Studies
7.Financial Disclosures and Conflicts of Interest in Clinical Research
8.FDA Form 1572 - Part 1
9.FDA Form 1572 - Part 2
10. Delegation of Authority Log – DOAL
11. Investigators Brochures
12. Protocol Continuing
13. IND Application
14. Trial Master File and DIA Model
15. Trial Master File Reference Guide
Regulatory Training Quiz (20 Questions)
1. Audits and Inspections in Clinical Trials
2. FDA Warning Letter
3.Site FDA Audit Inspection Checklist
4.How to Survive Through an FDA Inspection
5.Do and Don’ts during an FDA Inspection
Audits and Inspection Quiz
1.Compliance Requirements in Clinical Trials
2a.Subject Recruitment and Retention (Part 1)
2b.Subject Recruitment and Retention (Part 2)
3.Increasing Subject Compliance in Clinical Trials
4.Ethical Consideration Associated with Investigator Payment and Patient Recruitment
5.Advertisement Aid in Subject Recruitment and Retention
Medical Monitor Course Reviews
It is an eye opener that some investigators/ sponsors would go all the way to influence the decisions of subjects either to recruit or retain them in researc...
Read MoreIt is an eye opener that some investigators/ sponsors would go all the way to influence the decisions of subjects either to recruit or retain them in research study. I have learnt the methods towards compliance, recruitment and retention of subjects without any altruistic reasons.
Read LessThis was considerably more detailed than I anticipated. An excellent overview of all relevant regulations, SOP, templates, CFR, etc. for the conduct of US cl...
Read MoreThis was considerably more detailed than I anticipated. An excellent overview of all relevant regulations, SOP, templates, CFR, etc. for the conduct of US clinical trials
Read LessIt's a very structured course and covers all necessary aspects of Medical Monitoring
It's a very structured course and covers all necessary aspects of Medical Monitoring
Read LessThe course cover all the main information about clinical research in a clear and organized manner.
The course cover all the main information about clinical research in a clear and organized manner.
Read Lessexcellent
excellent
Read Lessa
Good format
Good format
Read LessReally beneficial except that it’s a little bit broader.
Really beneficial except that it’s a little bit broader.
Read Less
Get Your Advanced Physician Medical Monitor Certification (APMMC) to work in Clinical Research
At CCRPS, we help you secure doctor jobs for nonclinical positions through our advanced training modules. We have successfully helped train thousands of professionals. Whether you are a working professional looking for a career change or a student working towards this position, our nonclinical MD courses position you for success.
Physician-Created: Our course materials are created by a senior physician in collaboration with peer CRAs whose combined knowledge and experience bring a level of depth to our training that you cannot find elsewhere.
In-Depth Modules: Our Nonclinical MD courses includes a 107-detailed module that does more than just cover the basics. If you want to be a qualified and sought-after Medical Monitor, our training is the ideal fit.
17.5 CME: Upon completion of our course, you’ll receive 17.5 CME credits via the AMA & Joint Commission. We make sure you’re set up to jump right into your Medical Monitor career.
Flexible Learning: Whether you’re working or a practicing physician, our course provides flexible learning opportunities and self-paced coursework. Never worry about strict deadlines or tight schedules. Complete your coursework at whatever timing works for you.
International Accredited Certificate: Once you complete our in-depth 52 question exam, you’ll receive an internationally accredited certificate that’s valid for 10 years. We also include a letter of recommendation.
If you have questions, we have the answers.
You can email us at [email protected]! One of our experienced course representatives will get back to you within 1-2 business days.
The course is fully self paced and be completed in as little as 2 week or over the course of a few months.
Yes! CCRPS courses are accredited by the Accreditation Council for Clinical Research & Education (ACCRE) and jointly accredited by the American Medical Association (AMA), Accreditation Council for Pharmacy Education (ACPE), American Nurses Credentialing Center (ANCC), and Interprofessional Continuing Education (IPCE) to provide CME credits for professionals.
Students have 2 attempts to take the exam. If both attempts fail, students are still able to retake after a more thorough review of the course material.
Physician monitors properly review patient safety data, like adverse events, through EMRs and report back to the pharmaceutical company. Medical monitors are hired by CROs (contract research organizations) to provide medical expertise for quality, protocol review, patient's medical issues, and become key opinion leaders in the trial.
