Clinical Research Associate Training
Clinical Research Associate Certification
Advanced Clinical Research Associate Certification (ACRAC)

Clinical Research Associate Training
Advanced Clinical Research Associate Certification (ACRAC)
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1
Introduction
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Accreditation
FREE PREVIEW -
CME Handout
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Common Terminology Used In Clinical Research - Reference Glossary
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Commonly Used Abbreviations and Terms in Clinical Research
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2
Roles and Relationships in Clinical Trials
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Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor)
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Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)
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Communication between Blinded and Unblinded Staff
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Contract Research Organizations (Delegation, Responsibilities, Management )
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3
Sponsor and Investigator Roles
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ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles
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ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators
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ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities
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4
Clinical Trial Design
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Advanced Designs of Clinical Trials
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Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)
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Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)
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Blinding and Unblinding in Clinical Trials
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5
ICH GCP - Overview
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An Introduction to Clinical Research
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An Overview of ICH GCP
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6
ICH GCP - Ethical Research in Vulnerable Populations
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Ethics of Research Involving Children
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Ethics of Research Involving Mentally Incapacitated
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Ethics of Research Involving Prisoners
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Ethics of Research Involving Pregnant Women and Fetuses
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7
Adverse Events
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Advanced Review of Adverse Events
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8
Clinical Trial Protocol
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The Clinical Trial Protocol - Advanced Mastery Review
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Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)
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9
Protocol Deviations and Violations
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Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)
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10
IRB and DSMB
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Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)
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Data Safety Monitoring board- DSMB
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11
Review Questions
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REVIEW: 71 Review Questions for ICH GCP (optional, for study use)
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12
Site Monitoring Visits
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Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)
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13
Site Qualification Visit (SQV)
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Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)
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Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)
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14
Site Initiation Visit (SIV)
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Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"
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15
Routine Monitoring Visit (RMV)
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Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)
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16
Site Close-Out Visit (SCOV)
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Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)
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17
Tools for Monitoring Visits
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Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)
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Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)
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18
Audit and Inspections
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Audits and Inspections in Clinical Trials
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FDA Bioresearch Monitoring Program (BIMO)
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FDA Warning Letter
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Audits and Inspection Review Questions (optional for study purposes, not graded)
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19
Review Questions
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REVIEW A: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)
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20
SDV and Informed Consent
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ICH GCP Section 4.8 Informed Consent
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Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)
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Minimizing Source Data Queries In Clinical Trials
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21
Case Report Form
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Guidelines for Designing and Completing Case Report Forms
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Do’s and Don’ts of a Case Report Form Design
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22
Quality Control and Safety
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Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)
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ICH GCP - Safety of Human Subjects in Clinical Research
FREE PREVIEW
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23
Technology in Trials (IVRS, CTMS, EDC)
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ICH GCP - Trial Management, Data Handling, and Record Keeping
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Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)
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Clinical Trial Management System-CTMS
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Electronic Data Capture and Remote Data Capture Basics
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Electronic Regulatory Submission and Review
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24
Modernized Monitoring (Remote, Risk-based, Centralized)
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An Overview of Remote Monitoring - COVID-19 Update
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Remote Monitoring of Clinical Trials and EMRs
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Centralized Monitoring
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25
Pharmacovigilance and Regulatory Affairs
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Advanced Practice of Pharmacovigilance
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Regulatory Affairs for Clinical Trials
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26
Investigational Product
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Investigational Product Storage and Dispensing
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Investigational Product Accountability in Clinical Trials
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27
Local and Central Labs
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Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)
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28
Review Questions
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REVIEW PART B: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)
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29
Regulatory Documents
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Regulatory Documents in Clinical Trials
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Delegation of Authority Log – DOAL
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Investigators Brochure (IB)
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30
CFR 21 Part 11 - Electronic Signatures
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Code of Federal Regulations
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CFR 21 Part 11
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31
New Drug Application
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The Investigational New Drug (IND) & New Drug Application (NDA) Process
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Investigator Initiated Multi-Center Trials
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IND and IDE AE Reporting
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Safety Reporting Requirements for Sponsor Investigators of An IND
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32
Trial Master File
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Essential Regulatory Documents Binder Tab Organization (Trial Master File)
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Trial Master File Reference Guide
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Regulatory Training Quiz
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33
Disclosures and Payments for PI, Site, Patients
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Financial Disclosure- Duties and Strategies for Clinical Studies
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Payments and Budgeting for Investigators and Site
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Advertisement Aid in Subject Recruitment and Retention
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34
Patient Recruitment, Retention, and Compliance
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Patient Recruitment in Clinical Trials
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Patient Engagement and Retention in Clinical Trials
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Patient Adherence and Compliance in Clinical Trials
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35
Misconduct and Fraud
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Scientific Misconduct and Fraud
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Detecting Falsification
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36
Review Questions
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REVIEW PART C: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)
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37
Site Visit Templates
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SQV Checklist
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SQV Questionnaire
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SQV Assessment
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SQV Follow Up Letter
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SIV Agenda
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SIV Confirmation Letter
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SIV Report
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RMV Confirmation Letter/Fax
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RMV Report
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RMV Follow Up Letter
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CRA TRANSITION Letter/Email/Fax
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SCOV Confirmation Letter
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SCOV Agenda
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SCOV Report
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SCOV Follow Up Letter
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REFERENCE Module
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38
Interviewing and Career
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Interview Preparation
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Interview Preparation
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39
Final Examination
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Competency Exam
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Reviews
Phd In Monitoring
Adriana Paz Mancia
Very practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to ...
Read MoreVery practical given the potential scope of the material. The ability to cover so much material with examples is a real bonus and helps bring the content to life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful
Read Lesstwo weeks to update your resume
Shivani Dhotre
CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.
CRA training took me about 2 weeks straight. I learned a lot and videos were very refreshing. It was noticed by recruiters on resume.
Read LessLifechanging for my career
Latoya Munroe
The work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experienc...
Read MoreThe work load of modules are much but through the video lectures and the pdf materials it became very easy to understand and assimilate. It a great experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience
Read LessRemarkabley accurate lectures that go into so many reason...
Vaishnav Nath Ajeendra Nath
This course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quit...
Read MoreThis course was excellently executed, with informative lectures, and with innovative and practical learning plan which I could follow online and learned quite a lot of foundation and practical skills. This was an absolute wonderful learning experience on this platform, thanks for the assistance and hope to continue to learn from this experience, thank you...
Read LessA great review of clinical research for monitors
Jayant Shrivastava
I found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lo...
Read MoreI found this course to be a very advanced, in-depth review of clinical trials. Absolutely everything you need to know is included in the course. There are lots of templates in each module for SIV and other things which I really liked.
Read LessOnly resource CRAs need
Husnain ARSHAD
Very interesting and useful for CRA training
Very interesting and useful for CRA training
Read LessRefreshed my knowledge after 10 years in monitoring
Dr. Sharib Syed Muhammad
Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.
Best refresher for clinical researchers. A lot of content but can skim modules if you know them well.
Read LessLearn by examples. Great follow through videos.
Abiodun Adegbite
Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.
Exceptional information not found anywhere else. Everything has an example. Content just makes sense as dry as reviewing protocols and guidelines can be.
Read LessThank you!
Phillip Helmbright
I greatly appreciate the education I have received in this course! This is just the beginning, and I look forward to growing my career in the clinical resear...
Read MoreI greatly appreciate the education I have received in this course! This is just the beginning, and I look forward to growing my career in the clinical research field!
Read Less