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Auditing Clinical Trials for GCP Compliance

Jam-Packed with Checklists and Templates that can be IMMEDIATELY Implemented Back on the Job!

This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com

Agenda: Day One

I. Introduce Clinical Quality Assurance

  • Examine the role of quality assurance in clinical research
    • auditing clinical sites
    • writing audit findings and reports
    • becoming a regulatory and compliance "expert"
    • selecting and qualify vendors
    • hosting audits by the FDA

Discussion: Compare Participants' Levels of Experiences and Objectives for this Course

II. Achieve and Maintain GCP Compliance

  • Identify the fundamentals of a good clinical audit program
  • Demonstrate monitoring, auditing and investigator awareness
  • Examine the role of clinical quality assurance in ensuring good clinical practice

III. Audit Internal Clinical Files for GCP Compliance

  • Decide when to audit internal files
  • Determine what documents should be evaluated
  • Incorporate worksheets and checklists to facilitate the process

IV. Audit Clinical Sites for GCP Compliance

  • Define the differences between monitoring and auditing
  • Identify methods for launching and executing an audit
  • Improve your current GCP audit process
  • Audit essential documents
  • Employ effective interviewing skills

Exercise: Interviewing Techniques - Interviewing the Investigator and Study Coordinator

V. Audit Clinical Data

  • Evaluate subject selection, entry, treatment and evaluation
  • Utilize effective methods of data sampling
  • Incorporate data audit tools and worksheets

Exercise: Discuss the Importance of Performing a Trend Analysis

Booking Options

This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com

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