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8c Training by Competency

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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.

4b

These e-Modules are broken down by training competencies.

164

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

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    c8
  1. Trial Feasibility and Selection: Their Impact on Accrual
    2. 120
  2. Understanding Clinical Trial Protocols: Key Considerations for Effective Development and Feasibility
    3. af
  3. Introduction to Clinical Trials
    4. f4
  4. Implementing a Patient-Centered Informed Consent Process
    5. fa
  5. Improving Recruitment Accrual and Retention in Clinical Trials
    6. 10f
  6. The Drug Development Process: ICH E8(R1) General Considerations for Clinical Trials
    7. 6
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    101
  1. Ethics and Human Subject Protection: Comprehensive Introduction 
    2. f9
  2. Ethics and Human Subject Protection: A Refresher Course 
    3. dd
  3. Informed Consent Simulation 
    4. da
  4. Key Skills for Ensuring Quality Control through Risk-Based Decision Making
    5. 10c
  5. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
    6. 6
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    c1
  1. Expanded Access Programs for Drugs and Devices-OCR
    2. ed
  2. eTMF Training for eTMF Admin- OCR Tracking 
    3. c0
  3. eTMF Training for PennDocUser- OCR Tracking 
    4. c3
  4. eTMF Training for View only User- OCR Tracking 
    5. d0
  5. ICH Gap Analysis Tool
    6. cc
  6. Investigational New Drug (IND) - Sponsor Training - OCR 
    7. ca
  7. Investigational Device Exemption (IDE) Training - OCR 
    8. de
  8. Investigator Responsibilities 
    9. a2
  9. IRB 101 - OCR 
    10. d5
  10. Principal Investigator Compliance Assessment Review - PICA - OCR 
    11. 10b
  11. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety
    12. a7
  12. FDA Form 1572 Essentials
    13. c9
  13. Building Quality Management Systems for Sites and Sponsors
    14. 107
  14. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections
    15. 5
  15. 10c

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

    6
    16. 6
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9 e
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    af
  1. Clinical Trial Monitoring Basics
    2. c1
  2. Monitoring: Roles and Responsibilities - OCR 
    3. 100
  3. iConnect - PSOMs Recruitment Portal for Clinical Research - OCR 
    4. fa
  4. International Council for Harmonisation [ICH] Gap Analysis Tool
    5. dc
  5. Informed Consent Simulation 
    6. b8
  6. Monitoring Onboarding Program- OCR 
    7. ff
  7. Clinical Research Recruitment - Basics and Resources at Penn - OCR
    8. 9e
  8. ACRP Good Clinical Practice (GCP) ICH E6(R3)
    9. df
  9. Investigator Responsibilities 
    10. 11d
  10. Mastering the Event Reporting Cycle: Understanding Your Impact on Patient Safety - OCR  
    11. 119
  11. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections - OCR  
    12. 128
  12. Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense - OCR 
    13. c4
  13. Site Quality Management Tools: Writing Effective SOPs
    14. 10b
  14. Improving Recruitment Accrual and Retention in Clinical Trials - OCR  
    15. c7
  15. ACRP Clinical Research Knowledge Assessment (CRKA) 
    16. 101
  16. eResearch: Managing Clinical Trials in an Electronic Environment - OCR
    17. e5
  17. Key Skills for Ensuring Quality Control through Risk-Based Decision Making - OCR 
    18. 101
  18. Using Metrics to Improve Subject Recruitment and Retention - OCR 
    19. 6
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9 e
2d
d
    dc
  1. Informed Consent Simulation 
    2. df
  2. Investigator Responsibilities 
    3. d9
  3. Study Close Out Overview 
    4. cb
  4. Budgeting Basics
    5. 44
  5. Research Billing System (RBS) Training - OCR (Coming soon)
    6. c1
  6. SVE Training for CSO Read Only- OCR Tracking 
    7. c8
  7. SVE Regulatory User Training (2 hours) OCR Tracking 
    8. f3
  8. SiteVault Training for Read Only Users – OCR 
    9. 100
  9. iConnect - PSOMs Recruitment Portal for Clinical Research - OCR 
    10. ff
  10. Clinical Research Recruitment - Basics and Resources at Penn - OCR
    11. a7
  11. FDA Form 1572 Essentials
    12. c9
  12. Building Quality Management Systems for Sites and Sponsors
    13. 119
  13. Inspection Readiness: Best Practices for Managing Clinical Trial Inspections - OCR  
    14. 128
  14. Mastering Budgeting at Your Site: Building and Negotiating Clinical Trial Budgets that Make Sense - OCR 
    15. 5e
  15. Site Quality Management Tools: SOPs, Metrics, and Training - OCR  (Coming soon)
    16. 10b
  16. Improving Recruitment Accrual and Retention in Clinical Trials - OCR  
    17. c7
  17. ACRP Clinical Research Knowledge Assessment (CRKA) 
    18. 101
  18. eResearch: Managing Clinical Trials in an Electronic Environment - OCR
    19. e5
  19. Key Skills for Ensuring Quality Control through Risk-Based Decision Making - OCR 
    20. 101
  20. Using Metrics to Improve Subject Recruitment and Retention - OCR 
    21. 6
11 f
b
b
5 7
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9 e
2d
d
    37
  1. Using SlicerDicer for Research (Coming soon)
    2. f2
  2. TriNetx Penn Overview and Read and Acknowledge 
    3. 3b
  3. Guidance Document for Using Cosmos (Coming soon)
    4. 52
  4. Guidance Document for Using SlicerDicer for Research (Coming soon)
    5. f8
  5. REDCap: Best Practices for Maintaining HIPAA Compliance and Protecting Personal Health Information (PHI)
    6. 9e
  6. REDCap 101 OCR
    7. 6
  7. 9e

    REDCap 201 - OCR

    7
    8. ee
  8. PennCTMS Training: Case Report Form (E-CRF) and SAE Sign-off for Principal Investigators 
    9. 82
  9. PennCTMS Advanced - OCR (Submit a Helpdesk ticket to request training.)
    10. d0
  10. Essential Computer Skills for the CRC MS Excel 2010 Part I - OCR
    11. d7
  11. Essential Computer Skills for the CRC MS Excel 2010 Part II - OCR 
    12. 102
  12. eResearch: Managing Clinical Trials in an Electronic Environment - OCR
    13. 6
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