The Gemba that is Clinical Research Sites

Posted in Process Improvement

Providing site support and fostering best practice adoption

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A foundational element for any Clinical Quality Management System (CQMS) is adequate policies and procedures that provide framework for quality and compliance in clinical trial conduct. Clinical trial sites are at the intersection of action and oftentimes inherit burden they may not be equipped or resourced to handle. In Lean principles “going to Gemba” means going to “the real place” where activity is conducted. Clinical research sites are Gemba and sites are tasked with the critical responsibility of implementing trials, complex in design, within various infrastructures. ICH E8 (R1) calls for engagement of stakeholders in trial design and clinical research sites are a vital element to success. Site voice is essential to continuous improvement efforts that focus on implementation of protocol activities and participant involvement.

In support of clinical research sites, the WCG Avoca Quality Consortium (AQC) is adding 6 new foundational Site SOPs to our comprehensive Member-only Knowledge Center of 1,000+ leading practice documents and tools. These 6 SOPs are accompanied by 85+ additional related resources and templates that are referenced within each SOP to facilitate operational adoption.

WCG Avoca SOPs have been established for the following foundational elements of conduct:

  1. General Administration
    This SOP includes details pertaining to responsibilities for Good Clinical Practice, document development/change control, ensuring qualified site personnel, contract processes, and record management and retention.
  2. Regulatory Affairs
    This SOP includes details pertaining to essential documents, submissions to ethics committees, reporting requirements, and conflicts of interest.
  3. Project Management
    This SOP includes details pertaining to assessment of study feasibility, start-up activities, investigational product management, source documentation, monitoring visits, protocol compliance, and study completion.
  4. Trial Participant Management
    This SOP includes details pertaining to recruitment, screening, retention, informed consent, eligibility and enrollment, protection of confidential information, visit activity and assessments, and adverse events.
  5. Data Management
    This SOP includes details pertaining to use of electronic systems and clinical data management.
  6. Quality Assurance
    This SOP includes details pertaining to internal audit activity and regulatory authority inspections.

The addition of these resources to the AQC Knowledge Center provides necessary support to assist our site partners in developing and maintaining procedures that align with current regulations and guidances. With our mission as our underpinning, WCG is dedicated to supporting all stakeholders of the clinical trials industry in the relentless pursuit of finding answers! AQC Members can access these new resources within the Site Quality section of the Knowledge Center.

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Learn more about becoming a Member of the AQC and access over 1,000 leading practices and metrics, including a comprehensive Quality Agreement template.
Contact Us

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Author:

Trevor J. Cole, BHS, MBA, CCRC, PMP, RN

Associate Director, Client Delivery

WCG Avoca