PUBLICATIONS / PRESENTATIONS

Publications

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.