Penn Medicine Clinical Research

Training by Competency

The Office of Clinical Research partners with ACRP (Association of Clinical Research Professionals) to provide training modules for the Penn Clinical Research Professionals community. These can be accessed through Workday Learning. These e-modules are supplemented with Penn specific content.

These e-Modules are broken down by training competencies.

Training modules are broken down by core competency domains. These domains have been created by the Joint Task Force for Clinical Trial Competency.

  1. Trial Feasibility and Selection: Their Impact on Accrual
  2. Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility
  3. Introduction to Clinical Trials
  4. Implementing a Patient-Centered Informed Consent Process
  5. Improving Recruitment Accrual and Retention in Clinical Trials
  6. The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials

 

  1. Ethics and Human Subject Protection: Comprehensive Introduction 
  2. Ethics and Human Subject Protection: A Refresher Course 
  3. Informed Consent Simulation 
  4. Key Skills for Ensuring Quality Control through Risk-Based Decision Making
  5. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety

  1. Expanded Access Programs for Drugs and Devices-OCR
  2. eTMF Training for eTMF Admin- OCR Tracking 
  3. eTMF Training for PennDocUser- OCR Tracking 
  4. eTMF Training for View only User- OCR Tracking 
  5. ICH Gap Analysis Tool
  6. Investigational New Drug (IND) - Sponsor Training - OCR 
  7. Investigational Device Exemption (IDE) Training - OCR 
  8. Investigator Responsibilities 
  9. IRB 101 - OCR 
  10. Principal Investigator Compliance Assessment Review - PICA - OCR 
  11. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
  12. Form FDA 1572: Get it Right the First Time
  13. Building Quality Management Systems for Sites and Sponsors
  14. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections

  15. The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials

  1. Clinical Trial Monitoring Basics
  2. Monitoring: Roles and Responsibilities - OCR 
  3. iConnect - PSOMs Recruitment Portal for Clinical Research - OCR 
  4. International Council for Harmonisation [ICH] Gap Analysis Tool
  5. Informed Consent Simulation 
  6. Monitoring Onboarding Program- OCR 
  7. Clinical Research Recruitment - Basics and Resources at Penn - OCR
  8. Good Clinical Practice (GCP) Simulation - OCR 
  9. Investigator Responsibilities 
  10. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety - OCR  
  11. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections - OCR  
  12. Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense - OCR 
  13. Site Quality Management Tools: Writing Effective SOPs
  14. Improving Recruitment Accrual and Retention in Clinical Trials - OCR  
  15. ACRP Clinical Research Knowledge Assessment (CRKA) 
  16. eResearch: Managing Clinical Trials in an Electronic Environment - OCR
  17. Key Skills for Ensuring Quality Control through Risk-Based Decision Making - OCR 
  18. Using Metrics to Improve Subject Recruitment and Retention - OCR 

  1. Informed Consent Simulation 
  2. Investigator Responsibilities 
  3. Study Close Out Overview 
  4. Budgeting Basics
  5. Research Billing System (RBS) Training - OCR (Coming soon)
  6. SVE Training for CSO Read Only- OCR Tracking 
  7. SVE Regulatory User Training (2 hours) OCR Tracking 
  8. SiteVault Training for Read Only Users – OCR 
  9. iConnect - PSOMs Recruitment Portal for Clinical Research - OCR 
  10. Clinical Research Recruitment - Basics and Resources at Penn - OCR
  11. Form FDA 1572: Get it Right the First Time
  12. Building Quality Management Systems for Sites and Sponsors
  13. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections - OCR  
  14. Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense - OCR 
  15. Site Quality Management Tools: SOPs, Metrics, and Training - OCR  (Coming soon)
  16. Improving Recruitment Accrual and Retention in Clinical Trials - OCR  
  17. ACRP Clinical Research Knowledge Assessment (CRKA) 
  18. eResearch: Managing Clinical Trials in an Electronic Environment - OCR
  19. Key Skills for Ensuring Quality Control through Risk-Based Decision Making - OCR 
  20. Using Metrics to Improve Subject Recruitment and Retention - OCR 

  1. Using SlicerDicer for Research (Coming soon)
  2. TriNetx Penn Overview and Read and Acknowledge 
  3. Guidance Document for Using Cosmos (Coming soon)
  4. Guidance Document for Using SlicerDicer for Research (Coming soon)
  5. REDCap: Best Practices for Maintaining HIPAA Compliance and Protecting Personal Health Information (PHI)
  6. REDCap 101 OCR

  7. REDCap 201 - OCR

  8. PennCTMS Training: Case Report Form (E-CRF) and SAE Sign-off for Principal Investigators 
  9. PennCTMS Advanced - OCR (Submit a Helpdesk ticket to request training.)
  10. Essential Computer Skills for the CRC MS Excel 2010 Part I - OCR
  11. Essential Computer Skills for the CRC MS Excel 2010 Part II - OCR 
  12. eResearch: Managing Clinical Trials in an Electronic Environment - OCR

Coming Soon

Coming Soon