Resources

• Clinical Trial Contact Information

The U.S. National Institutes of Health (NIH) provides an overview of the components of a clinical trial.

Keeping essential documents is a mandatory part of conducting a clinical trial as per ICH Good Clinical Practices. Research related documents will be required by inspectors for the Health Canada HPFB Inspectorate for audit purposes in addition to the U.S. Food and Drug Administration for any U.S. government funded trials.

Documenting Consent

SOP Subject Management

SOP Records Management

SOP Management of Electronic Records and Signatures

SOP Information Access Control

SOP Data Management

SOP Adverse Drug Reaction

Responsibilities of Research Team

Note to File Template

Minutes of Team Meetings

Budget

Budget Template

Education

• 2011 Clinical Research Professional Development Resources
• Barnett Educational Services
• Institute of Translational Health Sciences Webinars

• Association of Clinical Research Professionals (ACRP)
• Society of Clinical Research Associates (SOCRA)

For questions regarding the clinical trial agreement process, and requirements for obtaining Fraser Health department agreements for providing research-related services and the privacy review process for obtaining an assurance of confidentiality and security agreement, contact Susan Chunick .

Go to Framework for a summary of the administrative process for research review.