Roswell Park Cancer Institute (RPCI) is dedicated to the safety of patients participating in clinical research studies, study compliance, and data integrity. The guidelines presented here pertain to the data and safety monitoring of all RPCI phase II and Pilot studies. RPCI phase I studies are monitored weekly by the RPCI Phase I Committee. Study-specific plans vary based on the degree of risk involved in participation and the size and complexity of the clinical research study. The development of study monitoring plans and reporting requirements are influenced by the study sponsor, the nature of the investigational agent, and the phase of the study. Each RPCI phase II and Pilot study must contain a plan for data and safety monitoring. The RPCI Data &Safety Monitoring Board coordinates and provides oversight for data and safety monitoring for all therapeutic trials consistent with the NIH Policy for Data and Safety Monitoring dated June 10, 1998, and updated June 22, 1999 and June 5, 2000. The Roswell Park Cancer Institute Data & Safety Monitoring Plan (DSMP) was approved by the National Cancer Institute on March 23, 2002. Data &Safety Monitoring is led by Alex Adjei MD, PhD, Associate Director for Clinical Research, with Stephen B. Edge, MD, functioning as the Chairperson of the Data and Safety Monitoring Board (DSMB). Clinical Research Services (CRS) provides the administrative support for the DSMB. Funding for this Resource provides continuing support for ongoing implementation and conduct of the DSMP. Data and Safety Monitoring responsibilities encompass three areas: support for the formation and maintenance of a Data and Safety Monitoring Board (DSMB), performance of regular audits of clinical research studies for study compliance and data quality and the ongoing monitoring of reported adverse events.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Center Core Grants (P30)
Project #
Application #
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Roswell Park Cancer Institute Corp
United States
Zip Code
Zhao, Zhiguo; Wen, Wanqing; Michailidou, Kyriaki et al. (2016) Association of genetic susceptibility variants for type 2 diabetes with breast cancer risk in women of European ancestry. Cancer Causes Control 27:679-93
Goossens, Maria E; Isa, Fatima; Brinkman, Maree et al. (2016) International pooled study on diet and bladder cancer: the bladder cancer, epidemiology and nutritional determinants (BLEND) study: design and baseline characteristics. Arch Public Health 74:30
Clyde, Merlise A; Palmieri Weber, Rachel; Iversen, Edwin S et al. (2016) Risk Prediction for Epithelial Ovarian Cancer in 11 United States-Based Case-Control Studies: Incorporation of Epidemiologic Risk Factors and 17 Confirmed Genetic Loci. Am J Epidemiol 184:579-589
Wilton, John; Kurenova, Elena; Pitzonka, Laura et al. (2016) Pharmacokinetic analysis of the FAK scaffold inhibitor C4 in dogs. Eur J Drug Metab Pharmacokinet 41:55-67
Sexton, Sandra; Tulowitzki, Ryan; Jones, Craig A et al. (2016) Involvement of the renin-angiotensin system in the development of nephrogenic systemic fibrosis-like lesions in the RenTag mouse model. Clin Exp Nephrol 20:162-8
Shafirstein, Gal; Battoo, Athar; Harris, Kassem et al. (2016) Photodynamic Therapy of Non-Small Cell Lung Cancer. Narrative Review and Future Directions. Ann Am Thorac Soc 13:265-75
Pharoah, Paul D P; Song, Honglin; Dicks, Ed et al. (2016) PPM1D Mosaic Truncating Variants in Ovarian Cancer Cases May Be Treatment-Related Somatic Mutations. J Natl Cancer Inst 108:
Austin, David C; Strand, Douglas W; Love, Harold L et al. (2016) NF-κB and androgen receptor variant 7 induce expression of SRD5A isoforms and confer 5ARI resistance. Prostate 76:1004-18
Rohrbach, Daniel J; Rigual, Nestor; Arshad, Hassan et al. (2016) Intraoperative optical assessment of photodynamic therapy response of superficial oral squamous cell carcinoma. J Biomed Opt 21:18002
Chinnam, Meenalakshmi; Wang, Xiaoling; Zhang, Xiaojing et al. (2016) Evaluating Effects of Hypomorphic Thoc1 Alleles on Embryonic Development in Rb1 Null Mice. Mol Cell Biol 36:1621-7

Showing the most recent 10 out of 1099 publications