Clinical Research Associate Certification

Advanced Clinical Research Associate Certification (ACRAC)

Industry-Recognized I 250 Hours I On-Demand I 17.5 CME I 100+ Modules I GCP E6R2 Complaint I Triple-Accredited I Instant Enrollment I 2+ Week Certification
Clinical Research Associate Certification

Clinical Research Associate Training

Advanced Clinical Research Associate Certification (ACRAC)

  • 1

    Introduction

    • Accreditation Statement

    • CME Handout

    • Common Terminology Used In Clinical Research - Reference Glossary

    • Commonly Used Abbreviations and Terms in Clinical Research

  • 2

    Roles and Relationships in Clinical Trials

  • 3

    Sponsor and Investigator Roles

    • ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

    • ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

    • ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

  • 4

    Clinical Trial Design

    • Advanced Designs of Clinical Trials

    • Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

    • Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

    • Blinding and Unblinding in Clinical Trials

  • 5

    ICH GCP - Overview

    • An Introduction to Clinical Research

    • An Overview of ICH GCP

  • 6

    ICH GCP - Ethical Research in Vulnerable Populations

  • 7

    Adverse Events

    • Advanced Review of Adverse Events

  • 8

    Clinical Trial Protocol

    • The Clinical Trial Protocol - Advanced Mastery Review

    • Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

  • 9

    Protocol Deviations and Violations

    • Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

  • 10

    IRB and DSMB

    • Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

    • Data Safety Monitoring board- DSMB

  • 11

    Review Questions

    • REVIEW: 71 Review Questions for ICH GCP (optional, for study use)

  • 12

    Site Monitoring Visits

    • Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

  • 13

    Site Qualification Visit (SQV)

    • Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

    • Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

  • 14

    Site Initiation Visit (SIV)

    • Site Initiation Visit (SIV) (Before, During, After, Letters, Checklists, and Report) - Review from "Types of Monitoring Visits"

  • 15

    Routine Monitoring Visit (RMV)

    • Routine/Interim/Periodic Monitoring Visit (RMV/IMV/PMV) (Before, During, After, Remote, Letters, Checklists, and Report)

  • 16

    Site Close-Out Visit (SCOV)

    • Site Close Out Visit (Before, During, After, Early Termination, Letters, Checklists, and Report)

  • 17

    Tools for Monitoring Visits

    • Monitoring Tools and Softskills (Tools, Templates, Communication, Metrics, Motivation, Humanistic Qualities)

    • Develop Templates for Monitoring Visits (Site Preparation, Pre-visit Letter/Agenda, Visit Checklist, Followup Letter, Visit Report)

  • 18

    Audit and Inspections

    • Audits and Inspections in Clinical Trials

    • FDA Bioresearch Monitoring Program (BIMO)

    • FDA Warning Letter

    • Audits and Inspection Review Questions (optional for study purposes, not graded)

  • 19

    Review Questions

    • REVIEW A: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)

  • 20

    SDV and Informed Consent

  • 21

    Case Report Form

    • Guidelines for Designing and Completing Case Report Forms

    • Do’s and Don’ts of a Case Report Form Design

  • 22

    Quality Control and Safety

  • 23

    Technology in Trials (IVRS, CTMS, EDC)

    • ICH GCP - Trial Management, Data Handling, and Record Keeping

    • Interactive Response Technologies in Clinical Trials (IVRS, IWRS, IRT, RTSM)

    • Clinical Trial Management System-CTMS

    • Electronic Data Capture and Remote Data Capture Basics

    • Electronic Regulatory Submission and Review

  • 24

    Modernized Monitoring (Remote, Risk-based, Centralized)

  • 25

    Pharmacovigilance and Regulatory Affairs

    • Advanced Practice of Pharmacovigilance

    • Regulatory Affairs for Clinical Trials

  • 26

    Investigational Product

  • 27

    Local and Central Labs

    • Local and Central Labs in Clinical Trials (Local, Regional, Central, GLCP, CLIA Cert, Lab Audit Checklist)

  • 28

    Review Questions

    • REVIEW PART B: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)

  • 29

    Regulatory Documents

    • Regulatory Documents in Clinical Trials

    • Delegation of Authority Log – DOAL

    • Investigators Brochure (IB)

  • 30

    CFR 21 Part 11 - Electronic Signatures

    • Code of Federal Regulations

    • CFR 21 Part 11

  • 31

    New Drug Application

    • The Investigational New Drug (IND) & New Drug Application (NDA) Process

    • Investigator Initiated Multi-Center Trials

    • IND and IDE AE Reporting

    • Safety Reporting Requirements for Sponsor Investigators of An IND

  • 32

    Trial Master File

  • 33

    Disclosures and Payments for PI, Site, Patients

    • Financial Disclosure- Duties and Strategies for Clinical Studies

    • Payments and Budgeting for Investigators and Site

    • Advertisement Aid in Subject Recruitment and Retention

  • 34

    Patient Recruitment, Retention, and Compliance

    • Patient Recruitment in Clinical Trials

    • Patient Engagement and Retention in Clinical Trials

    • Patient Adherence and Compliance in Clinical Trials

  • 35

    Misconduct and Fraud

    • Scientific Misconduct and Fraud

    • Detecting Falsification

  • 36

    Review Questions

    • REVIEW PART C: 65 Quality Monitoring Review Questions (optional for study purposes, not graded)

  • 37

    Site Visit Templates

    • SQV Checklist

      FREE PREVIEW
    • SQV Questionnaire

    • SQV Assessment

    • SQV Follow Up Letter

    • SIV Agenda

    • SIV Confirmation Letter

    • SIV Report

    • RMV Confirmation Letter/Fax

    • RMV Report

    • RMV Follow Up Letter

    • CRA TRANSITION Letter/Email/Fax

    • SCOV Confirmation Letter

    • SCOV Agenda

    • SCOV Report

    • SCOV Follow Up Letter

    • REFERENCE Module

  • 38

    Interviewing and Career

    • Interview Preparation

    • Interview Preparation

  • 39

    Final Examination

    • Competency Exam

Dream of becoming a CRA or getting promoted within the industry?

While there is an industry-wide shortage of CRAs, companies have been reluctant to fill those positions – citing insufficient training as one reason. To get your foot in the door, you need comprehensive training from a leading organization that provides you with all the knowledge and skills you need. Unfortunately, many training courses are not comprehensive enough to actually apply these tools and regulations. Thus, even experienced CRAs prefer to use us to "refresh" their training.

Start your CRA training instantly with our 2-4 month payment plans

Whether you are looking to transition from another field to become a Clinical Research Associate / Clinical Research Monitor, looking to move up within the industry, or begin a completely new career in this field, the CCRPS is the best industry choice for CRA training. This is a career that can bring in salaries of over $100,000 after three years of experience; the comprehensive ACRAC course is an educational program that opens this lucrative career path for you. Worried about financing your education? The CCRPS offers multiple payment options to suit every budget – pay in a single installment or choose a monthly payment plan.

ACRAC is the leading training program for CRAs

  • Take the fast track

    Take the fast track to a lucrative career as a Clinical Research Associate (CRA) to start earning salaries of $100,000 – 33% of new CRAs get promoted within a year

  • Get advanced training

    Get the most advanced training - ACRAC is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

  • Work at your own pace

    Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

  • Requirements

    Designed for those holding a minimum of a BA in Science, ACRAC is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

  • Syllabus

    ACRAC features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by senior CRAs, enabling students to build a deep knowledge of the industry.

  • Certification

    This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a 52-question exam. ACRAC also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position. ast