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Site Operations & Participant Experience

Investigational Product Accountability: Investigate a Reconciliation Gap

Coming soon

Trace an accountability discrepancy back through the records and escalate it correctly.

This course is still being built. Lessons are not available yet, and there is no enrollment, payment or certificate for it at this stage.

Practitioner · Self-paced

Illustration of labelled study vials and a barcode scanner beside an accountability table with one flagged row

What this course covers.

Who it is for
Site staff and monitors handling investigational product records.
What you will be able to do
Review an accountability discrepancy, document the evidence and prepare an appropriate escalation.
What you will produce
A documented discrepancy investigation and escalation note.
Systems referenced
No specific system access is required for this course.

Topics

  • Accountability logs
  • Reconciliation
  • Storage and handling
  • Escalation

All scenarios used in Academy courses are fictional practice material. Course work is practice, not employment experience, and it is not a verified competency result.

Register your interest in this course

Register your interest in this course.

Tell us a little about where you are now. Registering interest is not an enrollment and does not reserve a place.

  • Illustration of a study coordinator and a participant in conversation beside a signed consent form and a reconsent symbol
    Coming soon

    Consent in practice

    Handle the consent conversations that are not straightforward, and document reconsent properly.

  • Illustration of an eligibility checklist, a criteria table with query marks and a decision flowchart on a desk
    Coming soon

    Eligibility review

    Work an ambiguous eligibility case to the evidence, and know which questions belong with the investigator.

  • Illustration of a visit schedule on a tablet beside a procedure checklist, sample kits and a staffing diagram
    Coming soon

    Study visit planning

    Prepare a study visit so procedures, windows, staff and dependencies line up before the participant arrives.