Dana-Farber/Harvard Cancer Center, Boston, MA
Submitted by: Lawrence J. Ray

The following information was submitted by the applicant for the award. The Institute may have edited the text for presentation purposes. Health Improvement Institute has not verified, and does not guarantee, the completeness or accuracy of the information for any purpose. Institutions interested in adopting or adapting the practice would be well-advised to contact the person who submitted the application and to evaluate this and any additional information for their purposes.

Description: Quality Assurance Office for Clinical Trials (QACT) ensures high quality standards for the protection of human subjects, the management of clinical trials data, and the overall performance of research protocols.

Genesis: The genesis for QACT was the growth of the Dana-Farber Cancer Institute (DFCI) and restructuring to meet changing needs identified through self-assessment over time.

Experience: The QACT started as the Quality Control Center (QCC), which was created in 1986 to serve the growing need to manage the data for the increased number of in-house protocols at DFCI. QACT extends human subject protections into the protocol performance stages.

Compliance: QACT functions support the regulations as well as internal policies in many ways. Examples are 45 CFR 46.103 (b) 4 and 5, 21 CFR 312.53, IRB 21 CFR part 56 etc.

Protection of human subjects: The system demonstrates a commitment to the protection of human subjects by maintaining many of the necessary oversight committees and by working closely with the DFCI Office of Protection of Research Subjects (OPRS).

Monitoring and evaluation/outcomes: The QACT has been evaluated on multiple occasions by a variety of external and internal sources.

Innovation: QACT systems are unique in their structure. The amount and quality of oversight is increased by the centralized protocol registration process, formal auditing program, and the quality control of the PI initiated trials.

Replicability: Systems could be adopted by other Cancer Centers and also by other academic medical centers.

Applicant’s justification for award: The functions of the QACT are unique and can serve as a model for other large institutions.

For additional information:
Jane E. Russell
Tel: 617-632-3764
Fax: 617-632-2295
Email: jrussell@partners.org