e-Learning Modules

Welcome to OCRs listing of available eLearning modules.  All modules are available to University of Pennsylvania Health System and Perelman School of Medicine employees in Knowledge Link (KL) which is your Learning Management System (LMS).  Knowledge Link allows you to track and record all completed training in your LMS.

The eLearning modules listed below will provide human subject credit training hours towards the Penn CR: Onboarding Certificate and Certification Program.  We recommend you log into Knowledgelink (KL), with your PennKey before clicking on any of the links.  Completion of the module will be recorded in your LMS.

If you have any questions please contact Rosalyn McNeill at rmcneill@.upenn.edu with any issues regarding your recorded training and/or assistance operating the modules.

 

GCP and Ethics and Participant Safety Considerations

  • GCP for the Experienced Monitor: Improving Monitoring Efficiency and Effectiveness:
    Improves monitoring skills by breaking down Good Clinical Practice (GCP) into four memorable categories (Verify, Ensure, Determine and Communicate) to enable easy recall and application of the GCP E6 guideline during a participants work as a Clinical Research Associate (CRA). By providing learners with real-world illustrations and examples of efficient, effective monitoring approaches, this course improves monitoring skills and as a result enhances a participant’s value as a CRA.
     
  • GCP for the Experienced CRC: Partnering with Your Investigator to Reduce Risk and Avoid Common Inspection Findings:
    Assists Clinical Research Coordinators (CRCs), avoid today's most common inspection findings through practical, memorable application of the Good Clinical Practice (GCP) E6 guideline, and as a result reduce risk and attract more clinical trials to their Investigator's research site. By highlighting today's most common inspection findings — and providing learners with best practices, illustrations and examples to avoid them through correct application of GCP guidelines — this course will better prepare learners for audits/inspections and enhance their value as a CRC. 
     
  • GCP for the Experienced Investigator: Reducing Risks and Avoiding Common Inspection Findings:
    Assist Investigators, avoid today's most common inspection findings through practical, memorable application of the Good Clinical Practice (GCP) E6 guideline, and as a result reduce risk and attract more clinical trials to their research site. By highlighting today's most common inspection findings — and providing learners with best practices, illustrations and examples for avoiding them through correct application of GCP guidelines — this course will better prepare learners for audits/inspections.
     
  • GCP Test-Out Challenge: Demonstrate Your Mastery of GCP:
    Through four increasingly difficult levels of GCP questioning, this fun game assesses employees GCP knowledge, application, and analysis skills, and provides verification of GCP compliance. Each level consists of 25 questions with a required 80% minimum pass rate to progress through the game. Individuals unable to pass will be required to take a training program to obtain their GCP certificate so this program is not for those new to clinical research.
     
  • GCP: An Introduction to ICH GCP Guidelines:
    This course equips learners with not only an understanding of the core concepts of Good Clinical Practice (GCP) but how to put those concepts into action through a series of ongoing "knowledge checks" and real-world scenarios likely to be encountered during a clinical trial. This course provides formal training on the International Conference on Harmonization (ICH) Guidelines for GCP, the globally recognized standard for the conduct of clinical trials, for clinical research professionals with less than 1 year of experience.
     
  • Informed Consent:
    This fun game helps assess participant’s knowledge and skill levels related to ICH guidelines (E2a, E6, E8, and E9) and the Declaration of Helsinki.
    Participants will progress through four increasingly difficult levels of ICH guideline questioning in order to ultimately earn a ‘Gold Badge’ confirmation of knowledge. Each level consists of 25 questions with a pass rate of at least 80% required to progress through the game.
    At the game’s conclusion, participants/employers will receive a report on the participant’s strengths and weaknesses related to ICH guidelines.
    This is an ideal tool for employers to measure current or prospective employee’s knowledge of ICH guidelines and/or develop individual training plans that meet documented learning gaps – reducing redundant training, saving time and increasing the efficiency and effectiveness of your employee training programs.
     
  • ICH GCP Analysis:
    This fun game helps assess participant’s knowledge and skill levels related to ICH guidelines (E2a, E6, E8, and E9) and the Declaration of Helsinki.
    Participants will progress through four increasingly difficult levels of ICH guideline questioning in order to ultimately earn a ‘Gold Badge’ confirmation of knowledge. Each level consists of 25 questions with a pass rate of at least 80% required to progress through the game.
    At the game’s conclusion, participants/employers will receive a report on the participant’s strengths and weaknesses related to ICH guidelines.
    This is an ideal tool for employers to measure current or prospective employee’s knowledge of ICH guidelines and/or develop individual training plans that meet documented learning gaps – reducing redundant training, saving time and increasing the efficiency and effectiveness of your employee training programs.

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Clinical Trials Operations / Trial Management

  • eResearch: Managing Clinical Trials in an Electronic Environment:
    Transitioning from paper to electronic files in clinical research not only causes concerns related to subject information and trial data confidentiality, it also creates challenges with managing a multitude of systems. By following a reporter who is writing an article about these challenges, participants will learn how to setup up your electronic systems correctly the first time – or make necessary adjustments to overcome similar challenges. Topics covered include:
  1. The US and EU regulations and guidance documents related to the management and the use of electronic tools in clinical research
  2. Current trends in the use of electronic tools in clinical research
  3. The use of electronic systems at sited and sponsors with a focus on eCRF an eICF
  • Form 1572: Get It Right the First Time:
    This interactive course provides a one-stop-shop solution to help make participants comfortable with the document, its completion and management, and understanding of who should be on this form (and who should not). The course equips participants with relevant and complete reference information, examples, job aids (such as completion tips and decision trees), FAQs, and exercises that allow them to practice and check their understanding of the information application.
     
  • Iconnect:
    This is the electronic module for iConnect, which is UPenn PSOMs Clinical Trial Listing and Recruitment Portal. The goal is to encourage clinical research study teams to use iConnect as the primary recruitment tool for all research studies. This online training will demonstrate the application’s interface and allow users to request access. 
     
  • Inspection Readiness: Best Practices for Managing Clinical Trial Inspections:
    Good Clinical Practice Inspections readiness of Clinical Investigators and Sponsors/CROs and the focus will be on inspections by the U.S. Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA). Topics discussed both in general and specific for the FDA, MHRA and EMA (where applicable) are reasons for inspections, inspection objectives, types of inspections, inspections frameworks, selection and preparation strategies, routine inspection key focus areas, inspection findings classifications and guidance on providing acceptable responses to inspection findings.
     
  • Introduction to Clinical Trials:
    The course details how medical products are developed, how volunteer patients are protected, and who plays key roles in the development, research, review, and approval of medical products. The one-hour online program also explores how historical studies have laid the path for creation, revision, and enforcement of the ethical principles and guidelines governing today’s clinical trials.
     
  • Mastering Budgeting at Your Site: Building and Negotiating Clinical Trials Budgets that Make Sense:
    Through interactive discussions and Q&A sessions between a site budget and contract specialist (Mary) and her mentee (Sarah), course participants are taken on a deep exploration of budget process phases, clinical trial budget components, and more, including:
  1. Preparation and Study Protocol Review
  2. Budget Development and Negotiation
  3. Study Start-Up Costs
  4. Per-Subject Costs
  5. Variable Costs
  • Managing Billing Compliance Risks: Navigating Medicare in Clinical Trials:
    Noncompliance with Medicare billing requirements for clinical trials can leave an organization vulnerable to punitive action. This course teaches participants how to assess, prevent, and deal with noncompliance risks to help ensure compliance with Medicare rules for coverage of clinical trial-related costs.
     
  • Research Billing System (RBS) Training:
    The Research Billing System (RBS) is a web-based application designed for departments to review and confirm research technical charges. This e-learning module will discuss the distinct roles and responsibilities of the research team, and the process of reviewing charges for clinical research coordinators, Business Administrators, and Patient Accounting Representatives. 
     
  • Site Quality Management Tools: SOPs, Metrics, and Training:
    The key components related to quality management systems (Root Cause and CAPA) and risk-based decision making by providing the basic guidance and information needed to start setting up actual Quality Management Systems for sites.
    Participants will learn to describe the importance of quality processes in clinical research conduct by providing a framework for the necessary elements and systems that should be implemented by a site to ensure quality, such as Root Cause Analysis and Quality Management Systems, including the steps of quality processes and a pro-active approach, amongst others.
    Course includes tangible tools including recommended lists of site SOPs, sample SOPs, guidance on how to put SOPs in practice, sample quality-related metrics, and guidance for organizing useful training sessions.

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Data Management and Informatics

  • Theory to Practice: Operationalize Your Clinical Study Protocol:
    ACRP's on-demand eLearning course empowers learners to improve and enhance protocol interpretation and conduct, as well as protocol feasibility studies. By guiding learners through a mock protocol review, this course ensures learners are exposed to statistical considerations for clinical trials (as defined in the E9 Guideline) and that learners are able to operationalize their study protocol through comprehension of clinical trial development and design, data analysis, safety and tolerability evaluations, and reporting requirements.
     
  • Penn CR: Data Collections Management and Integrity:
    This e-learning module will discuss the importance of collecting quality data and how to properly manage your data for a clinical trial. This module will also provide Data Collection guidelines, plans, and responsibilities for study team members as well as good clinical data management practices and tips on collecting quality information while ensuring the privacy of the subjects. 

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Monitoring and Inspections Readiness

  • Building Quality ManagEment Systems for Sites and Sponsors: Root Cause and CAPA:
    The clinical research industry is undergoing a paradigm shift; it’s moving from a focus on detecting and fixing problems to a focus on preventing them, and sponsors and sites are implementing quality management systems to successfully make the switch. Learners should take this eLearning Course because it will develop or enhance their ability to contribute to the improved quality of their clinical trials by using tools such as ‘Corrective Action Preventive Action (CAPA)’ and ‘Root Cause Analysis (RCA),’ and by applying methodologies and key factors such as documentation best practices and risk management strategies that support and enhance the excellence of a quality management system.
     
  • Penn CR: Monitoring and Auditing:
     Effective monitoring and auditing of clinical research investigations is critical to the protection of human subjects as well as to the maintenance of the integrity of the research data. This e-learning module will take a closer look at the monitoring review process and what study teams should expect during a monitoring visit. This training will discuss the auditing processes and provide tools to prepare for a successful audit.
     
  • Principal Investigator Compliance Assessment Review (PICA) / Form View Only:
    This is an online module that covers the instruction portion on how to and fill out the form only; the full PICA online module is available in Knowledge Link under the search team PICA.

    OCR and the IRB have created this form to assist Penn PIs involved in human research stud(ies) and subject oversight. This form is required to be completed at the time of submitting a Continuing Approval for all greater-than-minimal-risk studies.  The study must be in an active status and being conducted at Penn or at an external site when the University of Pennsylvania is the IRB of record.

  • Risk-Based Monitoring: The Essentials for CRAs:
    ACRP's on-demand eLearning course empowers Clinical Research Associates (CRAs), to successfully prepare for and execute Risk-Based Monitoring plans. This course provides learners with a brief history on how Risk-Based Monitoring came about, how it is defined across the world, and most importantly how it will affect their work as a CRA.
  • Risk-Based Monitoring: The Essentials for CRCs:
    ACRP's on-demand eLearning course prepares Clinical Research Coordinators (CRCs), to make the necessary adjustments at their site for execution of Risk-Based Monitoring and equips learners to work effectively with Clinical Research Associates (CRAs) carrying out this monitoring approach. This course provides learners with a brief history on how Risk-Based Monitoring came about, how it is defined across the world, and most importantly how it will affect their work as a CRC (or research nurse, clinical trial assistant, trial assistant, project assistant).
  • Risk-Based Monitoring: The Essentials for Investigators:
    ACRP's on-demand eLearning course empowers Investigators, to modify their site quality control plans and to adjust processes in preparation for executing Risk-Based Monitoring strategies. This course provides learners with a brief history on how Risk-Based Monitoring came about, how it is defined across the world, and most importantly how it will affect their work as an Investigator.
     
  • Key Skills for Ensuring Quality Control through Risk-Based Decision Making:
    Risk-Based Monitoring (RBM) is an approach to quality control conducted by the sponsors of clinical trials that has grown in popularity in recent years, impacting both site and sponsor personnel. Overall trial execution in itself hasn’t been affected by this change. We all have the same end goals in mind: ensuring that trial subjects are safe at all times and that the products that make it to market do so based on decisions that have their origin in accurate and complete data. Quality control is and always has been a key task to meet these goals. A key skill to ensure risk-based strategies and to provide the most secure quality control is the ability to make risk-based decisions. Learners should take this eLearning course because it will help learners to make the right risk-based decision at the right time, ensuring no harm is done.

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Exam and Certification Preparation

  • Good Clinical Practice: Test-Out Challenge:
    Through four increasingly difficult levels of GCP questioning, this fun game assesses employees GCP knowledge, application, and analysis skills, and provides verification of GCP compliance. Each level consists of 25 questions with a required 80% minimum pass rate to progress through the game. Individuals unable to pass will be required to take a training program to obtain their GCP certificate so this program is not for those new to clinical research.
  • ACRP Certification Exam Preparation:
    ACRP's on-demand eLearning Course provides guidance on how to prepare for an ACRP Certification Exam (e.g., CCRA®, CCRC®, or CPI®) to candidates eligible to take the exam. Participants will become familiar with the format of the exam, tackle example questions, and conduct a personal gap analysis to ensure they are fully primed to earn their ACRP Certification.

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Study Start Up and Maintenance

  • iConnect:
    This is the electronic module for iConnect, which is UPenn PSOMs Clinical Trial Listing and Recruitment Portal. The goal is to encourage clinical research study teams to use iConnect as the primary recruitment tool for all research studies. This online training will demonstrate the application’s interface and allow users to request access.
     
  • Investigational Device Exemption (IDE) Sponsor Training:
    This e-learning module provides an overview of IDE regulations, guidelines, and Sponsor responsibilities.

    Topics include:

  1. Common Terminology
  2. Device Risk Determination
  3. When an IDE is Required
  4. Applicable Regulations and Guidance
  5. Content and submission process for an IDE
  6. Ongoing Management of an IDE
  1. IND and Drug Terms
  2. Applicable Regulations and Guidance
  3. When an IND is Required
  4. Sponsor & Investigator Responsibilities
  5. Contents and submission process for an IND Application
  • Penn CR: Data Collection Management and Integrity:
    This module will discuss the importance of collecting quality data and how to properly manage your data for a clinical trial. This module will also provide Data Collection guidelines, plans, and responsibilities for study team members as well as good clinical data management practices and tips on collecting quality information while ensuring the privacy of the subjects.
     
  • Penn CR: Monitoring and Auditing:
    Effective monitoring and auditing of clinical research investigations is critical to the protection of human subjects as well as to the maintenance of the integrity of the research data. This e-learning module will take a closer look at the monitoring review process and what study teams should expect during a monitoring visit. This training will discuss the auditing processes and provide tools to prepare for a successful audit.
     
  • Principal Investigator Compliance Assessment Review (PICA) / Form View Only:
    This is an online module that covers the instruction portion on how to and fill out the form only; the full PICA online module is available in Knowledge Link under the search team PICA.

    OCR and the IRB have created this form to assist Penn PIs involved in human research stud(ies) and subject oversight. This form is required to be completed at the time of submitting a Continuing Approval for all greater-than-minimal-risk studies.  The study must be in an active status and being conducted at Penn or at an external site when the University of Pennsylvania is the IRB of record. 

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