GCP…Check, Part 11 Compliance…Check, Quality System…What is that?

Every researcher is familiar with Good Clinical Practice (GCP) and most a familiar with 21 CFR Part 11 compliance. Both are critical components in ensuring that research is conducted in a safe, secure and ethical manor. While understanding these two regulations is the first part of the battle, getting to, and being able to effectively prove you are in compliance is an entirely separate battle. In order to do this, research organizations need to institute a quality system.

What is a quality system?

While regulatory guidelines dictate which processes (SOPs) must be in place when using computerized systems for clinical trials, a quality system is a collection of programs, policies, processes, and facilities that are designed to prevent errors and defects. A quality system is a means of providing documented evidence that a system or processes does what it was intended to do that that it does so accurately and consistently.

What goes into a quality system?

A quality system is comprised of many, many components; however, not all may be necessary in every situation. At a minimum, every quality system should be comprised of these three main categories:

  • How data is protected and secured
    • Development and Maintenance of SOPs
    • Reporting of SOP Deviations
    • Version/Change Control
    • Data Privacy / Protection
    • Database Security
    • Document / Study Binder Management
    • Data Management Roles and Responsibilities
    • Approval process
    • Study-Specific Database Design
    • Database Validation and Testing
  • How data is handled and processed
    • Data Management Plan
    • Data Monitoring Plan
    • Statistical Analysis Plans
    • e-CRF Design and Development
    • Data Entry and Verification
    • Discrepancy Management
    • Data Cleaning/Review/Validation
    • Editing Data
    • Lab Data Management
    • Data Extraction, Transfer, and Validation
    • Database Lock/Unlock/Closure
  • How people are trained
    • Sponsor level Training
    • Site level Training

Within each of these categories are numerous procedures that should be created, implemented and monitored. Successfully doing this at your research organization will help to better prove that quality and safety are a top priority within your organization.

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