Principal Investigator Training


This PI training is designed to ensure that all investigators have the information needed to conduct their research in compliance with both federal and state regulations.  The Office of Clinical Research provides resources and online training material for all PIs associated with Penn.  All completed online training is documented in Knowledgelink (KL) which is the University of Pennsylvania Learning Management System (LMS).

Principal Investigator Training - Entry Level

  • Ethics and Human Subjects Protection:
    • Define ethics;
    • 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; and
    • Resolve issues pertaining to actual or potential unethical conduct.
    • Includes video exercises
  • GCP An Introduction to ICH GCP Guidelines:
    • Define ethics;
    • 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; and
    • Resolve issues pertaining to actual or potential unethical conduct.
    • Includes video exercises
  • Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility Review:
    • Describe how quality protocols are developed.
    • Define the different study models and requirements for protocol authoring.
    • Review protocols to ensure feasibility and compliance.
    • Communicate the feasibility of a study.
  • Building Quality Management Systems for Sites and Sponsors: Root Cause and CAPA:
    • List the four components of a quality management system;
    • Explain the similarities and differences of quality planning, quality control, quality improvement, and quality assurance;
    • Define corrective and preventive actions (CAPA) and root cause analysis (RCA);
    • List the methodologies that support a quality management system during clinical trial conduct;
    • List two key factors that enhance the excellence of a quality management system.
  • Risk Based Monitoring — The Essential for Investigators:
    • 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; and
    • Apply RBM without jeopardizing patient safety, quality of data and regulatory compliance.
  • Theory to Practice: Operationalize your Clinical Study Protocol:
    • Summarize the considerations for overall clinical trial development;
    • Explain the different design configurations;
    • Describe the considerations for trial conduct and data analysis;
    • Explain how safety and tolerability is evaluated; and
    • Summarize trial reporting requirements.
    • Includes quiz- with 80% or better get an official certification of completion

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Principal Investigator Training - Mid | Senior Level

  • GCP for Experienced Investigator: Reducing Risks and Avoiding Common Inspection Findings:
    • Demonstrate qualifications and execute agreements to conduct clinical research with a research sponsor or institute;
    • Provide adequate medical care to a subject throughout the conduct of the clinical trial;
    • Compose communications with the IRB/IEC;
    • Conduct the trial in compliance with the protocol to include randomization and unblinding procedures;
    • Conduct Informed Consent (IC) Procedures according to local regulations, GCP and principles established by the Declaration of Helsinki; and
    • Develop timely and accurate records and reports.
  • The Drug Development Process: Improving Feasibility Feasibility and Exploring Your Trials Growth Potential:
    • Critically assess the general principles for the conduct of research;
    • Critically assess issues and considerations for development plans; and
    • Critically assess issues and considerations for an individual clinical trial.
  • Site Quality Management Tool: SOPs, Metrics and Training:
    • Explain 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.
    • Set up a quality process for your site.
    • Organize training sessions to ensure quality in clinical research.
  • Mastering the Event Reporting Cycle: Understanding the Impact on Patients Safety:
    • Define and describe clinical safety terminology;
    • Report safety concerns to stakeholders via the correct form and per ICH E2a Section III Standards for Expedited Reporting and include the appropriate Key Data Elements according to Appendix I;
    • Apply the guidelines for specific cases as defined under Miscellaneous issues (Section III E); and
    • Explain when a sponsor should amend the Investigator Brochure.
  • Inspection Readiness: Best Practices for Managing Clinical Trial Inspections:
    • Define the common preparation strategies for regulatory inspections;
    • Perform the investigator/site activities required to ensure regulatory inspection readiness at any time during the conduct of the clinical trial;
    • Perform the sponsor activities required to ensure regulatory inspection readiness at any time during the conduct of the clinical trial.

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Penn Specific Training

  • CITI Protection of Human Subjects Research Training — ORA
     
  • HIPAA Privacy and Security Education
     
  • PennCTMS
     
  • GCP Test Out Challenge — Any faculty and staff member who wants to test out of GCP training: 
    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.
     
  • ICH Gap Analysis Tool Objectives:
    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.
     
  • Form 1572: Get it Right the First Time:
    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.
     
  • Investigational Device Exemption (IDE) Sponsor Training:
    This e-learning module provides an overview of IDE regulations, guidelines, and Sponsor responsibilities.
    Topics include:
     
    • Common Terminology
    • Device Risk Determination
    • When an IDE is Required
    • Applicable Regulations and Guidance
    • Content and submission process for an IDE
    • 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:
    • IND and Drug Terms
    • Applicable Regulations and Guidance
    • When an IND is Required
    • Sponsor & Investigator Responsibilities
    • 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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