Good Documentation Practices for Clinical Trials

It has been said in the pharmaceutical industry “If it isn’t documented, it didn’t happen”.

Therefore, in Clinical Trials, all work is documented to provide written proof that a trial took place. For this reason, Good Documentation Practices (GDP) are critical. Records and reports related to clinical trial activities represent the official documented record of the trial itself.

For all aspects of the Clinical Trial and to meet regulatory requirements for the Food and Drug Administration (FDA) and other worldwide agencies, sites must utilize Good Documentation Practices in order to ensure the reliability ad integrity of information.

Areas Covered in the Session :

The webinar will review the general principles of Good Documentation Practices with emphasis on how these principles are required within Good Clinical Practices and worldwide regulatory agencies including description of the gold standard, ALCOAC:
A – Attributable
L – Legible
C – Contemporaneous
O – Original
A – Accurate
C – Complete

Who Should Attend:

  • Quality Managers
  • Clinical Auditors
  • Clinical Team Managers
  • Clinical Research Associates
  • Data Managers
  • GXP Professionals
  • Consultants

FDB3192

Pam Dellea-Giltner

Pam Dellea-Giltner is CEO and principal auditor of PDG Clinical Consulting LLC. She has over 30 years of experience in all aspects of Clinical Research Operations. Experience includes Quality Assurance/GCPs, Pre-Inspection Readiness/Audit Reponses, Project Management, Phase I-IV, post marketing and epidemiology studies, Study Management, Vendor/CRO Set up and management.

She has held positions in both pharmaceutical and CRO companies including GCP Auditor, Project Manager, Clinical Research Associate, and Trial Manager.

Currently she is Chairman of the ACRP CCRA Examination Committee and has been a certified CCRA since 2009.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.