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Ongoing multi-center clinical trials are crucial for Biophotonics to gain acceptance in medical imaging. In these trials,
quality control (QC) and assurance (QA) are key to success and provide "data insurance". Quality control and assurance
deal with standardization, validation, and compliance of procedures, materials and instrumentation. Specifically, QC/QA
involves systematic assessment of testing materials, instrumentation performance, standard operating procedures, data
logging, analysis, and reporting. QC and QA are important for FDA accreditation and acceptance by the clinical
community. Our Biophotonics research in the Network for Translational Research in Optical Imaging (NTROI) program
for breast cancer characterization focuses on QA/QC issues primarily related to the broadband Diffuse Optical
Spectroscopy and Imaging (DOS/I) instrumentation, because this is an emerging technology with limited standardized
QC/QA in place. In the multi-center trial environment, we implement QA/QC procedures: 1. Standardize and validate
calibration standards and procedures. (DOS/I technology requires both frequency domain and spectral calibration
procedures using tissue simulating phantoms and reflectance standards, respectively.) 2. Standardize and validate data
acquisition, processing and visualization (optimize instrument software-EZDOS; centralize data processing) 3.
Monitor, catalog and maintain instrument performance (document performance; modularize maintenance; integrate new
technology) 4. Standardize and coordinate trial data entry (from individual sites) into centralized database 5. Monitor,
audit and communicate all research procedures (database, teleconferences, training sessions) between participants
ensuring "calibration". This manuscript describes our ongoing efforts, successes and challenges implementing these
strategies.
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