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Clinical Trial Pharmacy: Running an IDS Site Without an IDS Team

  • 80 minutes
  • 42 slides
What we'll cover
  • 0:00 Solo IDS Reality Check
  • 8:00 Nonnegotiable IDS Functions
  • 18:00 Feasibility Through Pharmacy Lens
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What you'll take away

Practical shifts you can apply this week

  • Identify Nonnegotiable IDS Functions

    See which duties must stay owned and documented when one pharmacist is covering the full IDS load.

  • Evaluate Study Fit Safely

    Use protocol, staffing, and space signals to decide what your lean operation can actually support.

  • Design Minimal Control Workflows

    Build receipt-to-destruction steps that hold up in daily work and still make sense to an inspector.

  • Draft Escalation And Backup Rules

    Set clear triggers for urgent events, coverage gaps, and sponsor or PI communication before they collide.

  • Compare Accountability Approaches

    Weigh manual, hybrid, and tech-supported options for a low-resource IDS without adding busywork.

Agenda

What we'll cover

  1. 0:00

    Solo IDS Reality Check

    What running without an IDS team really means, where single-point-of-failure risk shows up, and why optimism is not a control.

  2. 8:00

    Nonnegotiable IDS Functions

    The core duties tied to subject safety, sponsor obligations, and documentation that cannot drift into informal coverage.

  3. 18:00

    Feasibility Through Pharmacy Lens

    How to screen protocol burden, storage needs, blinding complexity, and after-hours demands before saying yes.

  4. 28:00

    Lean Workflow Control Points

    A minimal-control model for receipt, storage, dispensing, returns, destruction, and deviation containment.

  5. 39:00

    Documentation That Survives Audits

    Logs, version control, signatures, and reconciliation narratives that explain what happened and why.

  6. 47:00

    Coverage, Escalation, And Boundaries

    Backup rules, stop-work triggers, holiday planning, and who gets called when the odd thing happens at 6:12 p.m.

  7. 54:00

    Technology And 30-Day Plan

    Minimal metrics, practical tools, recap, and a short action plan you can apply to one live study right away.

  8. 58:00

    Q&A And Next Steps

    Bring your workflow gaps, coverage worries, and feasibility edge cases for discussion.

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