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Responsible Donna Benson
Last Update 13/Nov/2026
Completion Time 5 minutes
Members 1
  • Finding Your Feet
    12Lessons ·
    • VIDEO — 1. The Industry: Who's Who in a Clinical Trial (1:07)
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    • VIDEO — 2. Our Study Team (2:29)
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    • VIDEO — 3. The Certificates (1:51)
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    • VIDEO — 4. SOPs (1:16)
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    • VIDEO — 5. Acronyms (1:27)
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    • VIDEO — 6. The HR Manual (1:18)
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    • VIDEO — 7. Privacy & Security (1:35)
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    • REFERENCE — The SOP Booklet and the HR Practices Manual
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    • What do we say about our work?
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    • Chunk Certificate — Finding Your Feet
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    • VIDEO — Meet Your Team: Finding Your Feet
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    • VIDEO TO COME — Meet Your Team: Finding Your Feet
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  • Starting a Study
    12Lessons ·
    • VIDEO — 8. How to Read a Protocol (1:24)
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    • VIDEO — 9. Regulatory Submissions: The Reg Pack (1:24)
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    • VIDEO — 10. You're Having a PSV! (1:04)
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    • VIDEO — 11. Start-Up: You Got the Award, Now What (1:08)
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    • VIDEO — 12. Start-Up for the Finances (1:28)
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    • VIDEO — 13. Start-Up for Audit Readiness (1:43)
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    • VIDEO TO COME — The SIV
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    • REFERENCE — The Reg Pack and the Start-Up Checklists
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    • A sponsor's Reg Pack is not complete. What happens?
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    • Chunk Certificate — Starting a Study
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    • VIDEO — Meet Your Team: Starting a Study
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    • VIDEO TO COME — Meet Your Team: Starting a Study
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  • Doing the Work
    12Lessons ·
    • VIDEO — 14. Prescreening (1:24)
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    • VIDEO — 15. Consenting (1:31)
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    • VIDEO — 16. The Flow of Testing (1:29)
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    • VIDEO — 17. R3: The New Rulebook (1:50)
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    • VIDEO — 18. Doing It Remotely (1:24)
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    • VIDEO TO COME — EDC
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    • VIDEO TO COME — Randomization
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    • REFERENCE — The Protocol Flow Chart and the Source Document Standard
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    • What may happen before a participant signs consent?
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    • Chunk Certificate — Doing the Work
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    • VIDEO — Meet Your Team: Doing the Work
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    • VIDEO TO COME — Meet Your Team: Doing the Work
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  • The System Around the Work
    11Lessons ·
    • VIDEO — 19. The R3 Updates (1:24)
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    • VIDEO — 20. What Is an Intern? (2:01)
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    • VIDEO — 21. The Arc of a Study (2:03)
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    • VIDEO — 22. The Study Admin File (1:40)
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    • VIDEO — 23. The Site Admin File (1:27)
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    • VIDEO — 24. ISO 9001: Say It, Do It, Prove It (1:34)
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    • REFERENCE — QM-001 and the Admin SOP Booklet
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    • People aren't scattered. What gets scattered?
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    • Chunk Certificate — The System Around the Work
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    • VIDEO — Meet Your Team: The System Around the Work
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    • VIDEO TO COME — Meet Your Team: The System Around the Work
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  • Procedures
    6Lessons ·
    • VIDEO — 25. Phlebotomy & Procedures: What You're Qualified to Do
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    • REFERENCE — The IP SOP and the Supervised-Draw Log
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    • How many supervised blood draws before sign-off?
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    • Chunk Certificate — Procedures
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    • VIDEO — Meet Your Team: Procedures
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    • VIDEO TO COME — Meet Your Team: Procedures
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  • The Finish
    4Lessons ·
    • If it isn't logged, what didn't happen?
      New 10 xp
    • Certificate of Completion — Onboarding: The Way We Work
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    • VIDEO — Meet Your Team: The Finish
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    • VIDEO TO COME — Meet Your Team: The Finish
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  • Practicums & The Human Gate
    3Lessons · 5 min
    • PRACTICUMS — The Week One Practice Form
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    • FORM — Practicum Log
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    • THE HUMAN GATE — Supervisor Sign-Off
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