QUICK BITE Lecture: FDA Warning Letters…Lessons Learned From Others
Quality Improvement Top Ten List: Findings and Corrective Actions
Independent QA/QI Program: An Indispensable Entity of a Human Research Protection Program
PUBLICATIONS / PRESENTATIONS
Publications
White S, Field M, and Wolf D. Developing and Implementing a Data and Safety Monitoring Plan. Applied Clinical Trials Sept. 2007.
Abstract: A data and safety monitoring plan (DSMP) is an essential part of any clinical investigation. As outlined in National Institutes of Health (NIH) guidelines (1, 2) the Code of Federal Regulations (CFR) (3, 4), and Good Clinical Practice Guidelines (GCP) (5), DSMPs are designed to ensure subject safety and data validity. Despite their importance, DSMPs in our experience are often less well defined than other components of a research protocol, particularly when they are designed by investigators themselves rather than by industry sponsors. Consequently, data and safety monitoring is frequently neglected during the study’s duration. To assist investigators in developing and implementing proper DSMPs , the Partners Human Research Quality Improvement Program (QI Program) developed a set of guidelines, including a checklist, to ensure not only that all necessary elements of a DSMP are included in the protocol, but that they are implemented accordingly as well throughout the duration of the study. The purpose of this article is to describe and share these guidelines. They are likely to be relevant to anyone involved in designing, implementing, or reviewing clinical research protocols, including investigators, study coordinators, research administrators, and IRB members at academic, medical, and research institutions.
Wolf D, O'Rourke P. Ensuring Investigator Compliance and Improving Study Site Performance: Implementing a Quality–Assurance and Quality–Improvement Program in Academic Health Centers. Clinical Researcher 2002; 2(5):26-30.
Abstract: Following the approval of a study by an institutional review board, investigators are responsible for the actual conduct of the study. Although investigators strive to comply with the regulations and guidelines, violations and/or deviations can occur. This might reflect an incomplete understanding of the Federal regulations, ethical guidelines and/or institutional requirements governing clinical research. Internal quality monitoring at the institution, conducted by an effective and comprehensive quality-assurance and quality-improvement program, can protect not only human subjects but also investigators.
Wolf D, O'Rourke P. Improving the Quality of Clinical Research: Recognizing Common Areas of Non-Compliance and Providing Quality-Assurance and Quality-Improvement Tips for Investigators. Clinical Researcher 2002;2(10):15–9.
Abstract: The International Conference on Harmonisation guideline for Good Clinical Practice (ICH–GCP), along with national regulations concerning clinical research conduct, dictate that the investigator has a critical role in assuming primary responsibility for the conduct of clinical research and human subject protection. Investigators must therefore be aware of, and in compliance with, these regulations and guidelines. While recognizing common areas of noncompliance helps to increase investigators’ awareness of these regulatory requirements, providing the investigator with specific quality-assurance and -improvement tips promotes compliance and improves the quality of research.
Presentations
Human Research Quality Improvement Program 2009