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