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A Practical Introduction to Clinical Research Compliance and Trial Conduct

  • 72 minutes
  • 38 slides
What we'll cover
  • 0:00 Why Compliance Shapes Conduct
  • 8:00 Roles, Oversight, Accountability
  • 17:00 Protocol Adherence In Practice
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What you'll take away

Practical shifts you can apply this week

  • Identify Core Compliance Obligations

    See how duties split across sites, sponsors, and CROs, and where accountability still stays put.

  • Compare Operational Roles Clearly

    Map what protocol, GCP, consent, safety reporting, and essential documents each do in daily trial work.

  • Diagnose Common Conduct Failures

    Trace deviations and documentation problems back to weak processes, fuzzy ownership, or missing controls.

  • Evaluate Risk-Reducing Controls

    Assess site and study checks that lower deviation rates, protect data quality, and support inspections.

  • Draft A Practical Action List

    Leave with next steps you can apply to an active study or one that is about to start.

Agenda

What we'll cover

  1. 0:00

    Why Compliance Shapes Conduct

    A quick hook, the trial-lifecycle lens, and why small gaps become major findings later.

  2. 8:00

    Roles, Oversight, Accountability

    Who owns what across sponsor, investigator, CRO, and vendors when work gets messy.

  3. 17:00

    Protocol Adherence In Practice

    How workflow design, visit timing, and eligibility checks drive deviations before anyone logs them.

  4. 27:00

    Consent, Safety, Subject Protection

    Where wishful thinking tends to fail fast, with examples on re-consent and reporting timelines.

  5. 38:00

    Data Integrity And Documentation

    ALCOA+, source-to-CRF alignment, late entry, and records that hold up under review.

  6. 48:00

    Monitoring, CAPA, Inspection Readiness

    What risk signals matter, how CAPAs fail, and what inspectors often notice first.

  7. 56:00

    Health Check, Recap, Q&A

    Turn the framework into a short review for one live study, then close with audience questions.

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