Clinical Research Associate Certification - CCRPS ACRAC (2023)

Table of Contents
Clinical Research Associate Training Clinical Research Associate Certification Take the fast track Get advanced training Work at your own pace Requirements Syllabus Certification Clinical Research Associate Training Introduction Roles and Relationships in Clinical Trials Sponsor and Investigator Roles Clinical Trial Design ICH GCP - Overview ICH GCP - Ethical Research in Vulnerable Populations Adverse Events Clinical Trial Protocol Protocol Deviations and Violations IRB and DSMB Review Questions Site Monitoring Visits Site Qualification Visit (SQV) Site Initiation Visit (SIV) Routine Monitoring Visit (RMV) Site Close-Out Visit (SCOV) Tools for Monitoring Visits Audit and Inspections Review Questions SDV and Informed Consent Case Report Form Quality Control and Safety Technology in Trials (IVRS, CTMS, EDC) Modernized Monitoring (Remote, Risk-based, Centralized) Pharmacovigilance and Regulatory Affairs Investigational Product Local and Central Labs Review Questions Regulatory Documents CFR 21 Part 11 - Electronic Signatures New Drug Application Trial Master File Disclosures and Payments for PI, Site, Patients Patient Recruitment, Retention, and Compliance Misconduct and Fraud Review Questions Site Visit Templates Interviewing and Career Final Examination Reviews Phd In Monitoring two weeks to update your resume Lifechanging for my career Remarkabley accurate lectures that go into so many reason... A great review of clinical research for monitors Only resource CRAs need Refreshed my knowledge after 10 years in monitoring Learn by examples. Great follow through videos. Thank you! FAQs

Clinical Research Associate Training

  • CertificatesAdvanced Clinical Research Associate Certification (ACRAC)(131)5.0 average ratingAdvanced Clinical Research Associate Certification (ACRAC) I 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

Advanced Clinical Research Associate Certification (ACRAC)

The ACRAC program offers 250 hours’ worth of specialized training in all knowledge domains and skill-sets required for a CRA, or Clinical Research Associate career. Comprising over 100 modules, this course spans the entire spectrum of clinical research, from the basics of Good Clinical Practice as defined by the International Conference on Harmonization (ICH-GCP), all the way to advanced know-how required for clinical report writing and site monitoring.

Clinical Research Associate Certification - CCRPS ACRAC (2)

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CRA Career GuideCRA Job Bulletin

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.

Clinical Research Associate Certification - CCRPS ACRAC (3)

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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.

Clinical Research Associate Certification - CCRPS ACRAC (4)

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

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Advanced Clinical Research Associate Certification (ACRAC)

Chapter 1: Introduction

This chapter orients you to the concept of Continuing Medical Education (CME) and outlines how the CCRPS CRA program contents meets AMA requirements for CME. Given that, across the US, physician practitioners are required to complete between 20 and 50 hours of CME credits yearly, the ACCME-accredited CCRPS CRA course can be used not only to build knowledge and skills in the field of clinical trial management, but also to further a successful medical career. Additionally, the introductory chapter introduces you to the clinical terminology and abbreviations commonly encountered in clinical research, for example, Investigational Product (IP), Good Clinical Practice (GCP), Institutional Review Board (IRB) and so on.

Chapter 2: Roles and Relationships in Clinical Trials

The unit presents the foundational background to beginning and building a career as a clinical research associate (CRA). As you know, a CRA plays a critical role in setting up as well as monitoring the clinical trials process for an investigational product or IP – a medical drug or device under development. In this unit, you will learn how a CRA interacts with other stakeholders, including the Clinical Research Organization (CRO) or Sponsor of the clinical trials, the Principal Investigator (PI) as well as other research site staff, the trials monitoring team including the Clinical Research Coordinator (CRC),other CRAs and the Data Safety Monitoring Board (DSMB), as well as the research ethics committee (Institutional Review Board or IRB).

Chapter 3: Sponsor and Investigator Roles

In this unit, you will gain insight into the ICH-GCP guidelines, particularly addendum E6, sections 2 through 5, which outline procedures and precautions essential for protecting the safety and wellbeing of human research participants during clinical research. These include guidelines for obtaining informed consent from human subjects, maintenance of trial records, reporting of compliance, safety and research progress, as well as procedures for suspension or termination of the trials process. The chapter familiarizes you with the critical importance of monitoring for Adverse Events (AEs), including types of AEs and regulations for documentation and reporting.

Chapter 4: Clinical Trial Design

In this chapter, you will acquire insight into the different phases of the clinical trials process, from the pre-clinical phase through Phases 0 to 4 of clinical testing. The unit will familiarize you with important concepts of clinical trials, such as the structure and goals of each phase of clinical trials, approaches to dosing, toxicology of pharmaceutical products, in vitro and in vivo testing, dose escalation and so on. Finally, the chapter reviews the FDA’s drug approval process.

Chapter 5: ICH-GCP – Overview

The chapter dives deep into GCP, including a review of the history of medical research leading up to the ICH-GCP. The unit covers all four QSEM categories of the guidelines for ensuring Quality, Safety and Efficacy of the IP, as well as Multidisciplinary guidelines (mainly pertaining to documentation and electronic data safety standards). In addition, the chapter includes an overview of MedDRA software that provides a standardized system of terminology and notation for documenting clinical research, as well as principles of budgeting for clinical trials.

Chapter 6: Ethical Research in Vulnerable Populations

The unit provides a detailed walk-through of the regulations and compliance requirements for conducting clinical trials with human subjects who meet the definition of a ‘vulnerable population’, including pregnant women and fetuses, children, mentally incapacitated individuals (those with cognitive functioning impaired by neurolopsychological conditions or chronic substance abuse), as well as prisoners. You will acquire familiarity with the challenges of research in such populations, including the requirement for parental consent, fair but not excessive incentive, justifiable deception or incomplete disclosure, coercive practices and so forth.

Chapter 7: Adverse Events

Through this module, you will gain a bird’s eye view of the protocol for documenting, reporting and responding to AEs or adverse events during the clinical trials process. The unit covers concepts such as expectedness, severity and seriousness of AEs, Adverse Drug Reactions (ADRs) as a sub-category of AEs, Investigational New Drug or IND reports, causality analysis for AEs and so on. In addition, the chapter reviews the responsibilities of both research sponsors as well as IRBs in sharing AE information with subjects.

Chapter 8: Clinical Trial Protocol

The chapter provides an in-depth tutorial on the structure and elements of a CTP or clinical trial protocol, as well as guidelines on writing a CTP. Important concepts reviewed include study Risk Benefit Analysis (RBA), study sample statistics (sample size, statistical power, plan for data analysis), risk management and study administration. Additionally, the module covers concepts central to study sample selection, addressing inclusion and exclusion criteria, especially safety and ethics considerations in sampling.

Chapter 9: Protocol Deviations and Violations

Through this unit, you will gain familiarity with the many potential causes of protocol deviations and violations, learning to distinguish between minor (deviations) and major departures or violations of protocol. Content provides understanding of the most commonly occurring violations, including both minor (off-schedule subject assessments, subjects’ use of prohibited drugs, and so on) as well as major violations (failure to obtain informed consent, failure to report AEs and so forth). Further, the chapter reviews principles for reporting protocol deviations, IRB approval for planned deviations and related concepts.

Chapter 10: IRB and DSMB

This chapter briefly reviews the history of IRBs and examines the principles guiding IRB decision-making. In addition, the unit discusses recent developments in compliance, including sIRB (single IRB) and SmartIRB for institutions that are part of the CTSA (Clinical and Translational Science Awards). The bulk of this module dives into the categories of IRB review, including full board and expedited review, examining criteria for review exemption such as educational or purely behavioral research, as well as studies collecting identifiable data, surveys and interviews.

Chapter 11: Review Questions

The module provides a self-assessment tool by including questions that review the content covered in previous chapters. The set of 71 questions examines all aspects of ICH-GCP previously discussed.

Chapter 12: Site Monitoring Visits

In this module, an overview is provided of the different types of site monitoring visits, including site selection or qualification visit, study initiation visit, routine or progress monitoring visit, as well as study termination or close-out visit. Important concepts discussed include pre-qualification preparations and site feasibility assessment as well as study monitoring criteria (data omission, incorrect entries, inaccurate calculations, documentation of corrections and so on). For each type of site monitoring visit, the chapter reviews relevant documentation.

Chapter 13: Site Qualification Visit (SQV)

The chapter gives an in-depth understanding of the stages and steps involved in selecting a study site. Elements reviewed within the module include the process of investigator selection and criteria for site evaluation (the four P’s: Patient, Protocol, Performance, Profit). Importantly, the module reviews the most common errors in feasibility assessment, including overestimation of sample availability at site, selection of site staff with low motivation, poor-performing sites owing to high competition for personnel and resources (for example, owing to multiple studies running on a single site), and so on.

Chapter 14: Site Initiation Visit (SIV)

The module dives into the details of an SIV or site initiation visit. You will review the procedure for pre-SIV preparation, including filing for IRB and other necessary approvals, permits and licenses. Additionally, the chapter examines elements of the SIV agenda, mainly orientation and training of site staff, creation of important study-related documents such as the Trial Master File (TMF) and post-SIV filing of compliance documents such as FDA form 1572 and Financial Disclosure Form (FDF) for relevant site personnel.

Chapter 15: Routine Monitoring Visit (RMV)

In this unit, the elements of a routine or periodic monitoring visit are discussed in detail. You will become familiar with the agenda of an RMV, which prioritizes receiving updates on AEs from site staff (incidence, documentation, seriousness and so on), as well as oversight of the overall progress of trials. The chapter covers different approaches to site monitoring, contrasting traditional (full-scale) monitoring with risk-based monitoring (RBM), as well as comparing on-site monitoring with remote monitoring. A crucial concept addressed by the unit is Source Data Verification (SDV), which is central to obtaining meaningful, high-quality data from clinical trials.

Chapter 16: Site Close-Out Visit (SCOV)

The module gives you a comprehensive overview of the protocol and procedures involved in terminating or closing out a trial site. Aspects covered in the chapter include pre-SCOV preparations such as IRB notification and schedule coordination among site staff (PI, other investigators, medical staff) and monitoring team (CRC, CRAs and so on), agenda for an SCOV – drug inventory management, database verification and lockdown, subject intimation and completion of all subject-related documents, staff-related documentation as well as other administrative tasks including close-out report compilation.

Chapter 17: Tools for Monitoring Visits

This unit outlines a host of tips and tools that can help a CRA in successfully tackling the complex process of monitoring clinical trials. The chapter lists numerous physical accessories you can use for effective monitoring, including scheduling and calculation aids, ready reckoners for drug information and medical terminology, as well as document templates to speed up the process of obtaining trial updates while also serving as checklists for the site visit agenda. Additionally, the unit highlights helpful strategies that a CRA can use to ensure that site visits go smoothly, from travel advice to team-building suggestions.

Chapter 18: Audit and Inspections

The module deals with one of the most crucial and often most feared aspects of a CRA’s career – audits and inspections by the CRO (sponsor), FDA or other regulatory authority. Starting from the basic distinction between an audit and an inspection, the chapter covers in detail the protocols for both audits and inspections. Crucially, the chapter will enable you to grasp the difference between a routine audit/ inspection and a ‘for-cause’ audit/ inspection. Further, it lays out the sequence of an FDA inspection in full (including a detailed walk-through of the FDA BIMO or Biomedical Research Monitoring Program inspection), and provides important guidelines on the do’s and dont’s for CRAs during an audit/ inspection, such as the critical ‘3 to 5 minute rule’. You will acquire familiarity with important audit and inspection-related documents such as FDA Form 482 (Notice of Inspection) and Form 483 (Notice of Observation) as well as the Establishment Inspection Report (EIR) prepared by the auditor/ inspector. Finally, you will gain insight into the classes of observations provided in an EIR, including NAI (no action indicated), VAI (voluntary action indicated) and OAI (official action indicated)—the last is commonly termed an ‘FDA warning letter’.

Chapter 19: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of clinical trial quality monitoring, including monitoring visits, tools as well as audits and inspections.

Chapter 20: SDV and Informed Consent

In this chapter, the ICH-GCP section 4.8 guidelines on obtaining informed consent from subjects are discussed in detail, highlighting the need for using non-technical language, transparent delineation of risks, consent without undue influence, obtaining consent (and assent) from minors and their Legally Acceptable Representatives (LARs), as well as consent from non-English speakers and sedated subjects. The chapter additionally covers important aspects of Source Data Verification (SDV) with respect to electronic as well as paper-based medical records, and highlights the central goal of SDV, which is to conform to ICH-GCP requirements that subject trial data (as recorded in Case Report Forms or CRFs) must correspond to source data (previous medical records).

Chapter 21: Case Report Form

The module provides an in-depth tutorial on the structure and elements of a Case Report Form or CRF, including the different forms for PI verification, subject enrollment, eligibility and randomization, medical history, physical examination and laboratory data, compliance, adverse events and so on. In addition, the chapter outlines important data notation rules, such as the use of accepted acronyms (‘ND’ for missing data and ‘UNK’ for unknown information, MM-DD-YY format, time-stamp data and so forth), as well as guidelines for the design of CRFs (such as consistency of notation, avoidance of data fields that can be computed and of duplicate data fields and so on).

Chapter 22: Quality Control and Safety

Within this unit, you will learn the central concepts of Quality Control (QC) in the context of clinical trials, including definitions of QC and its relationship with the complementary process of Quality Assurance (QA), the use of Key Performance Indicators (KPIs) in QC, need for a Corrective and Preventive Action (CAPA) plan and so on. Additionally, the module examines the QA process, focusing on the central role of RBM or risk-based monitoring in present-day QA as well as providing guidelines on Quality Metrics (QMs) for evaluating the trials process. The chapter also reviews ICH-GCP guidelines on subject safety, underlining risk-benefit assessment, stoppage rules (for instance, in case of SAEs) and reporting responsibilities. Finally, it introduces the FDA’s Human Research Protection Program (HRPP) as a platform that provides training and support for personnel involved in clinical trials.

Chapter 23: Technology in Trials

In this chapter, an in-depth tutorial is provided of the systems used in modern clinical trials for Electronic Data Capture (EDC) and database management. Systems such as Interactive Response Technologies (IRTs) including IVRS and IWRS (Interactive Voice and Web Response Systems, respectively) as well as RTSM systems for Randomization and Trial Supply Management are examined. The unit reviews the benefits of standardized data management and data sharing, approaches to database management and the concept of an Independent Data Monitoring Committee (IDMC). Critical elements of data integrity, such as proper anonymisation and coding, completeness of data, data safety precautions and logging of site visits and other progress reports are highlighted. The unit further examines the essential features of a good Clinical Data Management (CDM) system that complies with FDA CFR Title 21 and HIPAA regulations, such as setting access privileges, tracking changes and updates, data security and locking, flagging and reconciliation of AEs and so forth. Finally, the chapter looks at CTMSs (Clinical Trial Management Systems) in depth, covering the aspects that allow management of day-to-day trials in multi-site studies.

Chapter 24: Modernized Monitoring (Remote, Risk-based, Centralized)

This chapter offers a detailed walk-through of modern, remote monitoring of clinical trials, which evolved into a full-fledged system in response to the COVID-19 pandemic. Important concepts discussed include the critical site initiation process, Electronic Source Data Verification (ESDV) and FDA regulatory guidance for remote monitoring of clinical trials. In this module, you will learn how FDA’s ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) criteria for data quality have been adapted to remote monitoring. Further, the unit discusses how HIPAA compliance in remote monitoring is achieved by using limited data sets (wherein sensitive individual information is concealed through anonymous subject codes) regulated by data use agreements. Finally, the unit examines how risk-based monitoring approaches have allowed centralized monitoring to evolve into a cost-effective and safe method for clinical trial monitoring.

Chapter 25: Pharmacovigilance and Regulatory Affairs

Through this unit, you will gain insight into the process and rationale behind pharmacovigilance (PV) and its central role in the clinical trials process. The chapter reviews the statistics on AEs, distinguishes between Type A and Type B AEs, and profiles seriousness of ADRs or Adverse Drug Reactions as well as the iGuard Drug Risk Rating System. Importantly, the unit covers ADR causality assessment in detail, including both severity and probability assessment. An important element of PV addressed in this module is the Individual Case Safety Report (ICSR), its structure, content and role in trial monitoring. Other concepts discussed include types of PV inspections (routine vs. ‘for cause’), PSURs or Periodic Safety Update Reports and study criteria for instituting DSMBs (Data Safety Management Boards). Finally, the module also reviews the domain of Regulatory Affairs (RA) as a function of PV, outlining roles and responsibilities of RA personnel as well as the importance of RA in streamlining the process of drug development by ensuring compliance throughout manufacturing, clinical trials, marketing and advertising.

Chapter 26: Investigational Product

In this chapter, an in-depth review is provided of the protocol for receiving, storing and dispensing the IP or investigational product. At every stage, guidelines lay down strategies for ensuring verifiability, accountability and safety of both study subjects and staff. Thus, IP handling precautions include the need for logging date of manufacture, temperature throughout transit, as well as batch number and individual unit numbers (such as bottle or tube identifiers) carefully and accurately, as well as recording shipping details and filing shipping receipts. Additionally, the unit addresses the need for IP dispensing precautions, such as limiting dispensation to authorized personnel only, as well as maintaining individual subject IP logs.

Chapter 27: Local and Central Labs

The module profiles the evolution of lab testing in clinical trials, from error-prone localized laboratory testing to centralized testing that allows homogeneity of testing procedures and measurements, thus minimizing errors and improving outcomes. The chapter reviews standards for clinical trial laboratories as per the GLCP (Good Clinical Laboratory Practice) and CLIA norms (Clinical Laboratory Improvement Amendments), as well as providing guidelines for lab audits, including fire safety, protective gear, staff training and so forth.

Chapter 28: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, as well as a 15-item quiz. Questions and quiz examine all aspects of trial documentation (SDV, CRF, ICSR), quality control, pharmacovigilance, as well as IP and lab guidelines.

Chapter 29: Regulatory Documents in Clinical Trials

The chapter reviews essential documentation to be created and maintained throughout the course of the clinical trials, including the Trial Master File (TMF), FDA forms 1571, 1572, 3674, 3454/3455 and CFR Title 21 Form 312, besides ethics approval documents such as the IRB-approved protocol, informed consent form, subject education and study advertising materials. You will acquire in-depth familiarity with each of these forms, and learn the importance of maintaining and updating records, for example by incorporating IRB revisions and amendments, periodic renewals of permissions and licenses and copies of submitted reports. In addition, the unit summarizes the need for filing documents outlining study- and site-specific procedures, including SOP (Standard Operating Procedure), MOP (Manual of Procedures), Investigator Brochure (IB), Delegation of Authority Log (DOAL), site staff CVs, SAE notifications, logs of subject screening and enrollment, IP storage (temperature, humidity, etc.) and all relevant study parameters.

Chapter 30: CFR Title 21 Part 11 – Electronic Signatures

This unit gives you an overview of Title 21 of the FDA Code of Federal Regulations (CFR), including Chapter 1 sections on informed consent (Section 50), IRB approval (Section 56) and so on, Series on food (100), pharmaceuticals (200 and 300) and so on, as well as FDA Drug Schedules. The major part of the module focuses on Part 11 which deals with Electronic Records and Electronic Signatures (ERES), laying down the criteria for determining safety and reliability (trustworthiness) of electronic data and signatures.

Chapter 31: New Drug Application

Through this module, you will gain knowledge of the FDA process for evaluating a drug under development, and the role of a CRA in streamlining this process. An important distinction covered here is the difference between an IND (Investigational New Drug) and an NDA (New Drug Application). The chapter discusses in-depth the criteria used in evaluating an IND, including toxicology and pharmacokinetics data, as well as requirements for different drug classes (oncology vs. non-oncology). Additionally, the unit covers FDA requirements for AE reporting, including assessment of seriousness, expectedness and format for expedited reporting of life-threatening SARs, as well as safety reporting requirements for investigators.

Chapter 32: Trial Master File

The unit provides a detailed breakdown of the organization of a TMF or Trial Master File, listing the various binders that should be included within the TMF, as well as their contents. Thus, the TMF should contain binders pertaining to the study protocol and IRB, investigator qualifications, FDA forms and correspondence, FDFs or Financial Disclosure Forms, communications with the CRO, and other relevant trial aspects. A helpful templatic guide to creating a TMF is also provided in this chapter, as well as a self-assessment quiz of 10 items on important sections of a TMF.

Chapter 33: Disclosures and Payments for PI, Site, Patients

In this chapter, FDA guidelines regulating financial disclosure are discussed in-depth, covering the definition of ‘conflict of interest’ and the stipulations of Title 21 Section 54 on disclosure requirements. The unit helpfully contrasts FDA requirements with Canadian and UK/EU policies. You will study real life case examples of conflict of interest, as well as lawsuits pertaining to financial disclosure disputes to help gain a better understanding of the potential problems arising from failure to disclose financial interests in clinical trials. Another important dimension covered in the module is the regulation of payments to PIs and other investigators as well as patient payments, which must comply with CMS (Center for Medicare and Medicaid Services) policy on ‘fair market value’ as well as the Federal ‘Anti-Kickback Statute’. The unit contains guidelines on clinical trial budgeting and subject payments. Finally, the chapter reviews IRB guidelines on advertising to recruit human participants for clinical trials, including stipulations against misleading and coercive language, as well as excessive incentives.

Chapter 34: Patient Recruitment, Retention and Compliance

The unit provides an overview of the process of patient (subject) recruitment in clinical trials, from population research to identify motives for participation, to media support for building up public awareness and interest, to community and physician outreach for referrals and enrollment. Additionally, the chapter identifies common barriers to meeting recruitment goals and outlines strategies for maximizing recruitment, such as relaxing overly stringent criteria, offering reasonable incentives such as travel reimbursement and highlighting benefits of participation. Similarly, the unit covers common causes of patient drop-out as well as strategies for minimizing drop-outs, such as improving patient experience (increased attention and listening to patients, flexible scheduling of visits to suit patients’ convenience and so on). Finally, the unit discusses novel strategies to increase patient retention and improve compliance in clinical trials; these techniques harness technology to yield better outcomes, for example, simplifying form completion through digitized forms with auto-fill features, gamifying elements of compliance reporting, and so forth.

Chapter 35: Misconduct and Fraud

This module discusses the various motives for committing scientific fraud and the fallout of fraudulent practices in clinical trials. A scale for classifying errors in clinical trial data is presented, with ‘honest, isolated mistake’ at one end of the spectrum and ‘deliberate data falsification with malicious intent’ at the other. Types of clinical data that may be falsified, methods used in falsification (fabrication, substitution, omission), as well as scenarios in clinical trials where falsification may be occurring are presented. Through this chapter, you will gain familiarity with the signs to watch out for during the actual clinical trials process.

Chapter 36: Review Questions

The unit contains a self-assessment tool comprising 65 questions that review the content covered in previous chapters, including questions on all aspects of regulatory documents, site documents (TMF and contents), trial budgeting and payments, patient recruitment and scientific fraud.

Chapter 37: Site Visit Templates

This module contains a set of templates that you can use for documenting the details of site monitoring as a CRA, either in their current form, or in a form adapted to the needs of your own study. The templates included in this unit include:

Site Qualification Visit (SQV) – checklist for preparations, questionnaire for assessing the site prior to the actual visit, assessment form and follow-up letter

Site Initiation Visit (SIV) – agenda for visit, confirmation letter to request PI attendance during SIV, report following SIV

Routine Monitoring Visit (RMV) – confirmation letter to request PI attendance, report following RMV, follow-up letter

Site Close-Out Visit (SCOV) – confirmation letter to request PI attendance, agenda for SCOV, report following SCOV, follow-up letter

CRA transition letter – document notifying site PI of appointment of new monitor (yourself as CRA)

Chapter 38: Interviewing and Career

In this unit, you will find suggestions and recommendations for making a positive impact in interviews for CRA positions, as well as tips and strategies for making rapid progress in a clinical research career.

Chapter 39: Final Examination

This module comprises a comprehensive 51-item, self-paced quiz to assess your competency in the skills and knowledge required for a Clinical Research Associate position.

Clinical Research Associate Training

Advanced Clinical Research Associate Certification (ACRAC)

  • 1

    Introduction

    • AccreditationFREE PREVIEW
    • CME Handout

      (Video) CRP Certification: ACRP, SoCRA or other?

    • Common Terminology Used In Clinical Research - Reference Glossary

    • Commonly Used Abbreviations and Terms in Clinical Research

  • 2

    Roles and Relationships in Clinical Trials

    • Duties and Responsibilities of a Clinical Research Associate (CRA, Monitor) FREE PREVIEW
    • Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

    • Communication between Blinded and Unblinded Staff

    • Contract Research Organizations (Delegation, Responsibilities, Management )

  • 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

  • 5

    ICH GCP - Overview

    • An Introduction to Clinical Research

    • An Overview of ICH GCP

  • 6

    ICH GCP - Ethical Research in Vulnerable Populations

    • Ethics of Research Involving Children

    • Ethics of Research Involving Mentally IncapacitatedFREE PREVIEW
    • Ethics of Research Involving Prisoners

    • Ethics of Research Involving Pregnant Women and Fetuses

  • 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

    • ICH GCP Section 4.8 Informed Consent FREE PREVIEW
    • Source Documents and Informed Consent Forms (SDV Checklist, Informed Consent Checklist)

    • Minimizing Source Data Queries In Clinical Trials

  • 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

    • Quality Control in Clinical Trials ( QC/QA, KQI, QMS, Checklist)

    • ICH GCP - Safety of Human Subjects in Clinical ResearchFREE PREVIEW
  • 23

    Technology in Trials (IVRS, CTMS, EDC)

  • 24

    Modernized Monitoring (Remote, Risk-based, Centralized)

    • An Overview of Remote Monitoring - COVID-19 UpdateFREE PREVIEW
    • Remote Monitoring of Clinical Trials and EMRs

    • Centralized Monitoring

  • 25

    Pharmacovigilance and Regulatory Affairs

    • Advanced Practice of Pharmacovigilance

    • Regulatory Affairs for Clinical Trials

  • 26

    Investigational Product

    • Investigational Product Storage and DispensingFREE PREVIEW
    • Investigational Product Accountability in Clinical Trials

  • 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

    • Essential Regulatory Documents Binder Tab Organization (Trial Master File)FREE PREVIEW
    • Trial Master File Reference Guide

    • Regulatory Training Quiz

  • 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

  • 38

    Interviewing and Career

    • Interview Preparation

    • Interview Preparation

  • 39

    Final Examination

    • Competency Exam

Reviews

5 star rating

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 More

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 life through discovery and application. So many topics are covered almost like a bootcamp for phd in trials.This is helpful

Read Less

5 star rating

two 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 Less

5 star rating

Lifechanging 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...

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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 experience as I was introduced to Clinical Research Associate Certification. Hoping to build a career through this. Awesome experience

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5 star rating

Remarkabley 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...

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This 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 Less

5 star rating

A 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 More

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 lots of templates in each module for SIV and other things which I really liked.

Read Less

5 star rating

Only resource CRAs need

Husnain ARSHAD

Very interesting and useful for CRA training

Very interesting and useful for CRA training

Read Less

5 star rating

Refreshed 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 Less

5 star rating

Learn 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 Less

5 star rating

Thank 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 More

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 research field!

Read Less

FAQs

Is clinical research associate good job? ›

Working as a clinical research associate can be rewarding, as they have the opportunity to make a difference in medicine. The best part about the job is that it's an important position, ensuring research studies collect the right data, while also following ethical and legal responsibilities.

How do I become a CRA in USA? ›

A bachelor's degree and at least 3,000 hours of experience as a CRA.
...
The Society of Clinical Research Associates (SOCRA)
  1. At least two years of clinical research experience or 3,500 hours of part-time experience in the past five years.
  2. A degree in clinical research and at least one year of full-time experience.
14 Sept 2022

How do I become a CRA in Australia? ›

What skills and experiences are required to be considered?
  1. Bachelor's degree in healthcare or other life sciences discipline.
  2. Experience in a clinical research position preferred, e.g., in-house CRA, Clinical Trials Assistant or Clinical Trials Coordinator.

How do I become a CRA in UK? ›

To become a CRA it is necessary to hold an undergraduate or postgraduate qualification in nursing, life sciences (for example, biology, microbiology, toxicology, biochemistry, or pharmacology) or medical sciences (such as physiology, immunology, medicine, anatomy or pharmacy).

Is CRA job stressful? ›

I just hit my 1 year as a CRA not too long ago and I feel like it's such a stressful rollercoaster! I'm probably stressed 75-80% of the time. Even when I'm on vacation or sick, I can't help but think about all the work that still needs to be done. My body is feeling the stress.

Which is better CRA or CRC? ›

One key difference between the two is that a CRA usually does not interact with patients and will focus on data quality while a CRC does interact with patients and collects data.

How long is CRA course? ›

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA.

How long does it take to get a CRA certification? ›

Training to be a CRA through the ACRAC Program

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Do you need a degree to be a CRA? ›

A degree in a life science or other health-related discipline is usually needed to start a career in clinical research. However, there are courses and training available that can help you get a foot in the door if you haven't got the desired qualifications.

How do I become a CRA with no experience? ›

Requirements to become a certified CRA with no degree include: Complete two full-time years of CRA work within five years, or 3,500 hours of part-time work ACRP CCRA. Complete 3,000 hours performing essential duties. Submit a resume documenting and demonstrating job performance.

What is a CRA degree? ›

The Certified Research Administrator® (CRA®) is a designation granted in the United States by the Research Administrators Certification Council to individuals who demonstrate the knowledge necessary to serve as an administrator of professional and sponsored research programs.

How do you break into clinical research? ›

You can work for a contract research organization, a sponsor such as pharmaceutical or device company, a clinical research vendor, a regulatory authority such as the U.S. Food and Drug Administration, a nonprofit organization such as a patient advocacy group, an institutional review board, or a study site, to name some ...

What qualifications do you need to be a research associate? ›

A Research Associate usually has a bachelor's degree in an industry-relevant field. At a minimum, it's typically expected that individuals will have completed coursework in statistics, research methods and marketing. Courses in communication, economics and consumer behavior are also helpful.

Why do you want to become a clinical research associate? ›

If you choose to pursue a career in clinical research you can be sure that you'll make a difference in people's lives, whether through curing patients in new ways, or working to combat increasingly-prevalent issues like antibiotic resistance, especially given that no new antibiotics have been discovered since 1984.

How do I become a medical researcher UK? ›

A medical degree and some laboratory experience is all that is required for some graduate level research roles. However, audit and research experience (and having research published) or laboratory specialties will open up more opportunities. For more competitive senior positions a PhD will be a requirement.

Do all CRAs have to travel? ›

Most regional CRA jobs involve between 60-80% travel outside of your region, especially if you work for a larger CRO.

Where do CRAs travel? ›

A CRA usually travels each week to the clinical sites to review their enrollment, data entry and adherence to the protocol and relevant regulations. This position is a fast-paced, deadline-driven career.

Can a CRC become a CRA? ›

Frankly, there is a huge barrier transitioning from a Clinical Research Coordinator (CRC) to Clinical Research Associate (CRA). It's a move that many see as the next natural step toward career advancement within clinical research.

Is Clinical Research Associate certification worth it? ›

The bottom line is that while it may not be required, holding a certification will do nothing but help you in the long run. Being certified helps to reaffirm your job skills, industry and trial knowledge, and experience to hiring managers and yourself.

What is the difference between clinical research assistant and associate? ›

A research associate is a senior position with more responsibilities and usually has an advanced degree (e.g., a postdoctoral degree). A research assistant is usually a new member of the scientific industry who follows protocol and directions outlined by primary researchers.

What is the difference between clinical trial associate and clinical research associate? ›

In contrast to the role of a CRA, the role of a CTA is office-based and involves the preparation, maintenance, tracking and archival of study documentation, as well as the processing of data collected throughout the duration of the trial.

Are CRAs in demand? ›

Yes, clinical research associates are in demand.

In fact, over the next ten years, the need for clinical research associates is expected to grow by 36.4%. One example of this can be seen in the increase in monthly job postings for all clinical research positions, which has increased by 15% over the past five years.

Which course is best for clinical research? ›

Different clinical research courses
  • Post Graduate Diploma in Clinical Research.
  • BSc. in Clinical Research.
  • MSc. in Clinical Research.
  • Certificate in Clinical Research.
22 Mar 2022

How do I prepare for CRA? ›

ACRP Options 1 & 2
  1. Complete 3,000 hours performing essential job duties or 1,500 hours of equivalent work experience requirements through ACRP certifications or approved clinical research degree programs accredited by the Council for Higher Education.
  2. Submit a resume documenting and demonstrating job performance.

How do I prepare for a clinical research associate interview? ›

Below are our five tips to make sure that you are properly prepared for a clinical research job interview.
  1. Get your resume in tip-top shape. ...
  2. Be honest. ...
  3. Prepare, prepare, prepare. ...
  4. Do your research. ...
  5. Review your past research.
27 Jul 2016

What is a CRA position? ›

A clinical research associate (CRA) is a health care or life sciences professional who oversees clinical trials on behalf of pharmaceutical companies, medical research institutes and government agencies.

How much is CRA training? ›

Tuition fee: $1990.00 $799.00! Main Function of the Clinical Research Associate (CRA): The main function of a CRA is to monitor clinical trials.

› how-to-bec... ›

Clinical research associates (CRAs) are the professionals responsible for ensuring that clinical trials move forward following established guidelines and regula...
How To Get Clinical Research Associate (CRA) Experience · You've gone through four years of college education and have a degree engineering, science ...
Research what it takes to become a clinical research associate. Learn about the educational and certification requirements, job duties and salary...

Do clinical research associates travel a lot? ›

As a CRA you will get to travel to a lot of fun places

Most regional CRA jobs involve between 60-80% travel outside of your region, especially if you work for a larger CRO. Despite this amount of travel, most of the time you will only travel at most 1 time zone over.

What does a clinical research associate do? ›

What are the responsibilities of a clinical research associate? Typically, the key responsibilities of a CRA will include monitoring study sites and clinical activities, updating study documentation, maintaining clinical data systems and coordinating research procedures.

Why do I want to be a clinical research associate? ›

If you choose to pursue a career in clinical research you can be sure that you'll make a difference in people's lives, whether through curing patients in new ways, or working to combat increasingly-prevalent issues like antibiotic resistance, especially given that no new antibiotics have been discovered since 1984.

What makes a good clinical research associate? ›

To be a great CRA, one skill is needed: active listening.

Knowledge of clinical processes and the regulations that govern them? Ability to be flexible with travel and work schedules? Ability to spot errors that could gravely impact data and ultimately patient safety?

How much do CRAs earn? ›

Starting salaries for CRAs are in the region of £26,000 to £34,000. It's likely these posts will require some experience in a related area.

Is CRA a good place to work? ›

work life balance

Great work-life balance, Great supervisor, enough family time, remote work with a supportive team, and lots of coaching and training. Management comes highly recommended.

How much is CRA training? ›

Take advantage of our $1,795.00 price by registering early! The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA.

How do I become a CRA with no experience? ›

Requirements to become a certified CRA with no degree include: Complete two full-time years of CRA work within five years, or 3,500 hours of part-time work ACRP CCRA. Complete 3,000 hours performing essential duties. Submit a resume documenting and demonstrating job performance.

Which course is best for clinical research? ›

Different clinical research courses
  • Post Graduate Diploma in Clinical Research.
  • BSc. in Clinical Research.
  • MSc. in Clinical Research.
  • Certificate in Clinical Research.
22 Mar 2022

How do I prepare for a clinical research associate interview? ›

Below are our five tips to make sure that you are properly prepared for a clinical research job interview.
  1. Get your resume in tip-top shape. ...
  2. Be honest. ...
  3. Prepare, prepare, prepare. ...
  4. Do your research. ...
  5. Review your past research.
27 Jul 2016

What can I do after clinical research associate? ›

  • Project Management Jobs.
  • Business Development Jobs.
  • Data Analyst Jobs.
  • Clinical Trial Jobs.
  • Clinical Monitoring Jobs.
  • Clinical Trial Support Jobs.
  • Early Phase Services Jobs.
  • Information Technology Jobs.
24 Apr 2020

What questions do they ask at a CRA interview? ›

In-depth questions
  • How do you keep yourself organized?
  • What's your level of experience working in a medical environment?
  • What intrigued you about this company?
  • How would you describe a CRA job to someone unfamiliar with the field?
  • Have you ever encountered an ADR (adverse drug reaction) on a research site?
2 Apr 2022

How do I become a research associate? ›

A Research Associate usually has a bachelor's degree in an industry-relevant field. At a minimum, it's typically expected that individuals will have completed coursework in statistics, research methods and marketing. Courses in communication, economics and consumer behavior are also helpful.

How long does it take to get a CRA certification? ›

Training to be a CRA through the ACRAC Program

Designed for a total study time of approximately 250 hours, this training program can be completed at your own pace, or, for those able to dedicate the whole day to study, in as little as two to three weeks.

Are CRAs in demand? ›

Yes, clinical research associates are in demand.

In fact, over the next ten years, the need for clinical research associates is expected to grow by 36.4%. One example of this can be seen in the increase in monthly job postings for all clinical research positions, which has increased by 15% over the past five years.

Do CRAs travel a lot? ›

CRAs are often away for several days at a time depending on the current workload. This can be difficult on families and personal relationships. While the author travels extensively, there are some times when he travels more than others. Sometimes he does back-to-back visits and may be gone for several days at a time.

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