Regulation & Quality

Clinical Trials BC provides consulting, training and resources to help participating BC research organizations and personnel excel within one of the world’s most heavily-regulated industries. Our specialized expertise helps BC research sites develop their knowledge and infrastructure to support world-class clinical trials activity.

Provincial QMS Program

The Clinical Trials BC Quality Management System Program is a new provincial program offering services, resources and support for the development and implementation of Quality Management Systems (QMS) in centres, institutions and agencies. The program includes:

  • QMS Leader training
  • Development and implementation planning
  • QMS systems and tools
  • Community of practice
  • Mentorship and ongoing support

Read more about the QMS Program.

Regulatory Consulting Services

Clinical Trials BC offers a range of regulatory consulting services, including:

  • General inquiries: for regulations and compliance issues.
  • Interpretive application: concerns requiring explanation of applicable regulations (e.g. domestic, multi-regional, multi-regulatory authority).
  • Study development: providing a regulatory lens for complex or multi-regional studies
  • Regulatory site visit and assessment: site, program or institutional support or training on topics such as vendor qualification, internal review guidance, regulatory peer review of quality controlled documents, etc.
  • Audit and inspection preparation and follow-up assistance: site, study, program or institutional level.
  • Regulatory document review.

Compliance and Quality Education and Training Program

Our current education and training offerings include:

Audit and Inspection Preparation Program

The Audit and Inspection Preparation Program (AIPP) approaches compliance and quality through education and planning. Research team members have access to training and materials to promote compliance, introduce compliance management and quality management concepts, and increase team comfort in preparing, hosting and following up with audits and inspections.

The program includes:

  • Workshop Series (six sessions) with certificate
  • Tools and clinical trials AIPP training manual version 3
  • Audit preparation site visits
  • Post-audit response and CAPA planning

Hot Topic Series 2018

Clinical Trials BC offers education on a range of current regulation and quality issues:

  • Quality Management Systems Overview (lecture)
  • Corrective Action and Preventive Action (CAPA) for Sites (workshop)
  • Risk Management Overview: for Sites and Investigator Initiated Studies (lecture and discussion)
  • Good Documentation Practices II (workshop) – Recording (workshop)
  • Canadian Regulatory Environment 2018 (lecture)
  • Global Compliance Report 2018 (lecture)

Includes supporting materials for team training or for use in regional or program research days. Certificates are issued.

Good Clinical Practice (GCP) Portfolio (E6R2)

To help you prepare for GCP E6R2, we offer:

  • On-Site Classic GCP E6R2 Research Team Training
  • On-Site GCP Team Refresher Training
  • General Lecture ICH modules, now featuring:
    • General Considerations in Clinical Trials ICH E8
    • Good Clinical Practice ICH E6 Changes and Status (major sponsor and site modules)

Investigators Only Program 2018

For 2018, two topics are offered in a choice of café scientifique or lunch & learn formats:

  • Investigator Oversight
  • Investigator Responsibilities