Mark S. Jones

Total integrated performance excellence system (TIPES): A true north direction for a clinical trial support center

This paper presents the quality journey taken by a Federal organization over more than 20 years. These efforts have resulted in the implementation of a Total Integrated Performance Excellence System (TIPES) that combines key principles and practices of established quality systems. The Center has progressively integrated quality system frameworks including the Malcom Baldrige National Quality Award (MBNQA) Framework and Criteria for Performance Excellence, ISO 9001, and the Organizational Project Management Maturity Model (OPM3), as well as supplemental quality systems of ISO 15378 (packaging for medicinal products) and ISO 21500 (guide to project management) to systematically improve all areas of operations. These frameworks were selected for applicability to Center processes and systems, consistency and reinforcement of complimentary approaches, and international acceptance. External validations include the MBNQA, the highest quality award in the US, continued registration and conformance to ISO standards and guidelines, and multiple VA and state awards. With a focus on a holistic approach to quality involving processes, systems and personnel, this paper presents activities and lessons that were critical to building TIPES and establishing the quality environment for conducting clinical research in support of Veterans and national health care.

Use of a Remote Computerized System for Study Documentation in Clinical Trials

In an effort to decrease the complexity of drug administration at the clinic site and increase automation in the packaging, distribution, and administration of clinical trial supplies, the Cooperative Studies Program Clinical Research Pharmacy Coordinating Center developed the Remote Drug Treatment Information System (RDTIS). This system uses bar code technology to assist in the verification of drug assignments, management of dose adjustments, and documentation of clinical doses. The system also assists the clinical site in the collection of adverse medical events, documentation of patient enrollments and terminations, and incorporation of lab findings. Drug accountability is provided through daily monitoring of shipments and drug usage. This paper describes RDTIS, with an overview of the hardware and software design, implementation issues, and issues relevant to clinical trial administration. RDTIS can assist in automating the collection of routine data through the use of bar code technology, help prevent dispensing errors, and assure the maintenance of the blind.