The Quality Assurance program aims at providing regulatory oversight to the investigators and their study teams to promote research compliance and provide education and training. CTO will work at drafting the quality assurance/quality improvement plan tailored to the requirements of each study and its study team.
CTO has established Standard Operating procedures for each of below mentioned services that comply with the MCW and CHW IRB requirements, ICH-GCP and federal regulations.
Conduct routine audits
Conduct for–cause audits
Conduct audits at sites other than MCW/FH for multi-site studies
Conduct mock-FDA inspections
Develop and implement CAPA (Corrective and preventive action plans)
Assist in preparation for an external audit
Consultation to Investigator and Sponsor-Investigators who do not have an established monitoring and quality assurance plan for their studies
To request our services, please complete and submit the form below.