Presentation on theme: "Clinical QA Data Audits A GCP Point of View Linda Del Paggio GCP Compliance BioBridges, LLC."— Presentation transcript:
Clinical QA Data Audits A GCP Point of View Linda Del Paggio GCP Compliance BioBridges, LLC
Agenda Introduction ICH and GCP GCP and Data Integrity Investigator Site Audits Data Vendor Audits
The ICH E6 Good Clinical Practice Consolidate Guideline: Good Clinical Practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects.
The ICH E6 Good Clinical Practice Consolidate Guideline: Compliance with the standard provides public assurance that the rights, safety and well-being of subjects are protected, consistent with principles that have their origin in the Declaration of Helsinki and that the clinical trial data are credible.
GCP & Data Integrity What is GCP? A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial subjects are protected.
GCP & Data Integrity Selected Principles of the ICH GCP All clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation, and verification. Systems with procedures that assure the quality of every aspect of the trial should be implemented.
GCP & Data Integrity Specific ICH Regulations ICH 5.1.1 – the sponsor is responsible for maintaining quality assurance and quality control systems with written SOPs to ensure trials are conducted and data are generated, recorded, and reported in compliance with the protocol, GCP, and applicable regulatory requirements.
GCP & Data Integrity Specific ICH Regulations ICH 5.1.3 – Quality control should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly.
Investigator Site Audits First line of data retrieval ALCOA Attributable Legible Contemporaneous Original Accurate