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An Interactive Guide to Good Clinical Practice

This eLearning module reviews the basics of GCP, an ethical and scientific quality standard that assures that clinical data and results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are respected.

  • Regulations around GLP, GCP and GMP.

  • Phases of clinical trials

  • Aspects of a good clinical trial

  • On the basis of ICH E6 guidelines, define

  • Roles and responsibilities

  • Data management

  • Data analysis and data integrity in a clinical trial

  • Reporting the results of a clinical trial

  • Storage & retention of records

Why it matters

Knowledge of GCP helps improve clinical data quality\, speeds up new drug approvals and reduces costs to sponsors. The safety and well-being of trial subjects participating in clinical trials are the utmost importance. GCP requires managing unforeseeable risks and inconveniences and weighing them against anticipated benefits to trial subjects and society at large. GCP also provisions for consent and confidentiality of trial subject data.

Who is it for

All investigators\, drug sponsors\, IRB representatives \, physicians\, pharmacists\, laboratory technicians\, and quality assurance personnel involved in conducting clinical trials should complete this module.

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