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Clinical Research Support

Quality Assurance Office for Clinical Trials (QACT)

Quality Assurance Office for Clinical Trials (QACT)

Mission Statement

To ensure high-quality standards for data collection and management of clinical trials and to provide a resource to the Dana-Farber/Harvard Cancer Center (DF/HCC) for the clinical trial process, including computerization of protocol data.

Contact Information

Location: DFCI, 20 Overland St., 2nd floor
Phone: (617) 632-3761
Fax: (617) 632-2295
Email: QCC@partners.org - for off-study information and DF/HCC Clinical Research SOP Changes

Purpose:

To ensure high-quality standards for data collection and management of clinical trials and to provide a resource to the Dana-Farber/Harvard Cancer Center (DF/HCC) for the clinical trial process, including computerization of protocol data.

Functions:

  • Quality Assurance review of systems relating to the conduct of clinical trials and reports to senior management updating status of clinical research management.
  • Protocol Patient Registration which includes:
    • Initial registration of all protocol patients
    • Eligibility checking and confirmations of registration
    • Monitoring protocol accrual
    • Providing statistics for DFCI and DF/HCC
  • Computerization and quality control of protocols written within DFCI and DF/HCC
    • Forms design
    • Database design and maintenance
    • Develop protocol specific quality control procedures to maintain data integrity
    • Maintain database documentation
    • Report preparation
    • Detailed monitoring of data for PI Initiated Trials
    • Implementation of electronic data capture (EDC)
  • Clinical Trials Education
    • Collaboration with Education Coordinator for Seminars, orientations, resources, Clinical Research Training (4 times/yr), and the Guide to the Clinical Trial Process
  • DF/HCC Auditing Program
    • Conduct over 90 audits per year for ongoing protocols
    • Initiate systems changes resulting from audit findings
    • Report results to ClinPOC
    • Administrative management of Data and Safety Monitoring Board (DSMB) for Phase III protocols and Data and Safety Monitoring Committee (DSMC) for Phase I and II high-risk protocols
  • Meeting Coordination
    • Clinical Investigations Policy and Oversight Committee (ClinPOC)
    • Clinical Trials Operations Committee
    • Clinical Research Operations Committee
    • Audit Subcommittee
    • Multi-Center Coordinating Committee (MCCC)
  • Other
    • Policies relating to clinical trials
    • Management of master List Serve Program for dissemination of information on clinical trials

Protocol and Accrual Statistics

There are various reports available from the QACT relating to accrual statistics for research protocols. The Protocol System Coordinator or Protocol Registrar must be contacted if a report is needed.  Lists can be generated for any protocol, and can contain a summary of information about each patient registered on the protocol. The lists are generally sorted chronologically by date entered, but they can also be sorted alphabetically by patient name, or in terminal-digit order of hospital medical record number. Other reports that can be generated are: Special Protocol Accrual Report (this report presents accrual by periods across protocols or by specific categories such as disease sites, phase and sponsor) and Protocol Population Accrual Figures (Race, Gender, Ethnicity, and Service Area). This type of report is useful for grant applications.