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Clinical Research Support

Quality Assurance Office for Clinical Trials (QACT)

Quality Assurance Office for Clinical Trials (QACT)

Contact Information

Location: DFCI, 20 Overland St., 2nd floor
Phone: (617) 632-3761
Fax: (617) 632-2295
Email: QACT@partners.orgCTEO@dfci.harvard.edu       

Purpose:

The QACT enables the Cancer Center to conduct high quality clinical research and is central to the DF/HCC Data and Safety Monitoring Plan. This is achieved by: educating PIs and study teams; assisting in the successful activation of approved clinical research; ensuring the efficient and accurate collection of data to meet protocol objectives; and monitoring and auditing trial progress to ensure compliance with regulations, standards of operation, and subject safety. As a centralized DF/HCC support office, the QACT assure consistency across and within institutions.

Functions:

Quality Assurance 

Internal Audit Program

  • Full scope audits
  • Targeted audits
  • Risk Assessments (Site, Program and/or Investigator)
  • Audit Committee

Multicenter Coordination

  • Multi-Center Coordinating Committee
  • Multi-Center Data and Safety Monitoring Plans
  • Site Feasibility and Selection Qualifications
  • External Auditing for DF/HCC Initiated Multi-Center trials

Quality Control 

Data Management (PI Initiated)

  • Electronic Case Report Form design
  • Data App. Customization, Implementation, and Support
  • QC of Data
  • Reporting

Registration

  • Patient Protocol Registration
  • National Registration (CTRP, Clinicaltrials.gov)

Data and Safety Monitoring

  • Data and Safety Monitoring Board
  • Data and Safety Monitoring  Committee

Research Training / Credentialing

Training

  • Human Protection Training (CITI)
  • Good Clinical Practice (CITI)
  • Investigator training/ qualifications
    • 1-on-1 for new Overall PIs
    • Annual NCI investigator registration

Research Policy

  • DF/HCC research policies
  • The Guide to Human Subject Research

Operations

Oversight Committees

  • Clinical Investigations Leadership Committee (CLC)
  • Clinical Trials Operations Committee (ClinOps)            

Statistics

  • Grants Management
  • DF/HCC Administrative Institutional Planning