SOPs for GCP-Compliant Clinical Trials:
A Customizable Manual for Sites

A benefit of WCG Avoca Quality Consortium membership

The WCG Avoca Quality Consortium (AQC) is a pre-competitive collaborative that was established in 2011 with the objective to improve the quality of clinical trials and bring key stakeholders in the process into alignment.

As part of AQC membership, consortium members receive access to a comprehensive Knowledge Center of 500+ leading practice documents and tools. This includes 6 Foundational Site SOPs. These downloadable and customizable SOPs cover 26 key operational activities and are accompanied by 85+ additional related resources and templates that are referenced within each SOP to facilitate operational adoption.

The WCG Avoca GCP-Compliant Site SOPs cover the following foundational elements of conduct:

• 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.

• Regulatory Affairs
  This SOP includes details pertaining to essential documents, submissions to ethics committees, reporting requirements, and conflicts of interest.

• 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.

• 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.

• Data Management
  This SOP includes details pertaining to use of electronic systems and clinical data management.

• Quality Assurance
  This SOP includes details pertaining to internal audit activity and regulatory authority inspections. The addition of these resources to the WCG Avoca Quality Consortium Knowledge Center provides necessary support to assist site partners in developing and maintaining procedures that align with current regulations and guidances.

The WCG Avoca Quality Consortium is dedicated to supporting all stakeholders of the clinical trials industry in the relentless pursuit of finding answers! To learn more or receive access to these invaluable resources within the WCG Avoca Quality Consortium Knowledge Center, contact Russ Titsch at russ.titsch@wcgclinical.com.