Office of Clinical Research

• Good Clinical Practice (GCP) Simulation:

This interactive simulation-powered training program helps ensure compliance with international standards for Good Clinical Practice in clinical trials (ICH E6).

What makes this program unique is its sharp focus on the application of GCP principles rather than the acquisition of knowledge. By immersing learners in a cutting-edge adaptive learning environment, ACRP’s GCP Simulation builds strength in the critical thinking and decision making needed to apply GCPs in the real world.

Playing the roles of study coordinator, investigator, sub-investigator, research nurse, and study monitor/CRA in a variety of simulated scenarios, course participants develop a 360-degree understanding of GCP principles while practicing application of associated competencies in a safe environment – before mistakes are made in real studies.

• Ethics and Human Subjects Protection: A Comprehensive Introduction:

Learn how to avoid unethical conduct in clinical trials and how to resolve issues pertaining to actual or potential unethical conduct through a thorough review of the historical evolution of ethics in clinical research, the primary guidelines involving ethical considerations in clinical research, the elements of those guidelines, and the consequences of unethical conduct and decisions.

After completing this activity, the participant should be better able to:• Define ethics in clinical research• Describe the historical evolution of ethics in clinical research• Identify the primary guidelines of ethical considerations in clinical research• List the key elements of the primary guidelines• Communicate the importance of ethics in clinical research• Recognize the consequences of unethical conduct in clinical trials• Resolve issues pertaining to actual or potential unethical conduct

Playing the roles of study coordinator, investigator, sub-investigator, research nurse, and study monitor/CRA in a variety of simulated scenarios, course participants develop a 360-degree understanding of GCP principles while practicing application of associated competencies in a safe environment – before mistakes are made in real studies.

• Ethics and Human Subject Protection: A Refresher Course:

This course provides refresher training to clinical research professionals who have completed the initial comprehensive ACRP Human Subject Protection course titled “Ethics and Human Subject Protection: A Comprehensive Introduction”

• Define unethical conduct in clinical research
• Define ethical tensions in clinical research
• Explain the difference between fraud and misconduct
• Explain how ethical guidelines became mandatory in clinical research
• Identify the benefits of adhering to ethical principals
• Recognize the impacts and consequences of unethical conduct in clinical trials
• List measures to prevent unethical conduct
• Discuss how to approach suspected fraud or misconduct

• Informed Consent Simulation:

This interactive, simulation-powered training program helps ensure informed consent is obtained by the right subject, with the right forms, by the right people, through the right process, at the right time, and with the right documentation.

• Describe the elements that constitute a compliant informed consent process
• Explain the theory as well as best practices for obtaining and documenting informed consent with clinical research participants
• List the core competencies required of clinical research professionals to properly conduct and document the informed consent process

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• 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- Patient Recruitment Management System:
  iConnect's PRMS allows research teams to create recruitment methods such as flyers, unique webpages, pre-screeners, tracked methods, all in one platform. Using iConnect as the primary recruitment tool for all research studies can allow research teams to centrally list, manage and track all their recruitment strategies. 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

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• Statistical Principles for Clinical Trials: Overview of ICH E9:
  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.

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• Building Quality Management Systems for Sites and Sponsors:
  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.
• 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.
• Clinical Trial Monitoring Basics:
  This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach? It then builds on that content to examine the impact on the clinical research site and CRAs in topics related to new approaches to data management, study budget, and contract considerations. Learning Objectives• Define Risk-Based Monitoring (RBM)• Describe significant differences in utilizing an RBM approach as compared to 100% on-site monitoring and 100% centralized monitoring• Follow risk-management strategies as part of overall quality management procedures when setting up or evaluating a protocol and related activities• Apply RBM without jeopardizing patient safety, quality of data and regulatory compliance
• 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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• ACRP Certification Exam Preparation eLearning Program
  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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• 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

• Investigational New Drug (IND) Sponsor Training:
  This e-learning module provides an overview of the IND regulations, guidelines, content, and Sponsor responsibilities.
  
  Topics include:

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

• 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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