Quality Assurance Program

The Quality Assurance Program is designed to provide collegial and constructive monitoring and training as part of SCI’s Clinical Research Oversight Group (CROG). 

Monitoring is defined as:

The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), GCP, local guidelines for practice, and the applicable regulatory requirement(s).

The Quality Assurance team is responsible to ensure that:

• Investigator-initiated trials (IIT) and cooperative group trials are reviewed regularly for participant eligibility, regulatory compliance, and safety issues.
• Adverse reactions are reported in compliance with local and government regulations, and as appropriate, are reviewed by the Data & Safety Monitoring Committee.
• Data collected on these trials is accurate, reliable, verifiable, and reproducible.
• This contributes to ensuring that SCI trials remain in compliance with all institutional and federal regulations.

When a new cooperative group or IIT study is opened to accrual, a Clinical Research Quality Assurance Specialist/Internal Monitor from the Quality Assurance team will perform a quality review of:

• The protocol, consent, and eligibility checklist.
• Ensure the trial's clinical research staff understands expectations of quality research conduct and SCI’s standard operating procedures.

The Clinical Research Quality Assurance Specialist/Internal Monitors perform a quality check of:

• Eligibility for the first three patients enrolled on a new IIT
• The first patient enrolled on a cooperative group trial.
• If an IIT is multi-site, they also review the first patient enrolled from each study site.

The Clinical Research Quality Assurance Specialist/Internal Monitors also assist with:

• Internal monitoring as the study progresses.
• Quality checks across all studies to ensure SCI guidelines are being followed.