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.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA016056-34
Application #
8078036
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
34
Fiscal Year
2010
Total Cost
$152,230
Indirect Cost
Name
Roswell Park Cancer Institute Corp
Department
Type
DUNS #
824771034
City
Buffalo
State
NY
Country
United States
Zip Code
14263
Vexler, Albert; Yu, Jihnhee; Zhao, Yang et al. (2018) Expected p-values in light of an ROC curve analysis applied to optimal multiple testing procedures. Stat Methods Med Res 27:3560-3576
Mussell, Ashley L; Denson, Kayla E; Shen, He et al. (2018) Loss of KIBRA function activates EGFR signaling by inducing AREG. Oncotarget 9:29975-29984
Hirose, Yuki; Nagahashi, Masayuki; Katsuta, Eriko et al. (2018) Generation of sphingosine-1-phosphate is enhanced in biliary tract cancer patients and is associated with lymphatic metastasis. Sci Rep 8:10814
Kesterson, Joshua P; Szender, J Brian; Schaefer, Eric et al. (2018) Evaluation of Association Between Gynecologic Oncology Fellowship Length and a Career in Academic Medicine. J Cancer Educ 33:141-146
Samuel, Sandeep; Mukherjee, Sarbajit; Ammannagari, Nischala et al. (2018) Clinicopathological characteristics and outcomes of rare histologic subtypes of gallbladder cancer over two decades: A population-based study. PLoS One 13:e0198809
Yendamuri, Sai; Groman, Adrienne; Miller, Austin et al. (2018) Risk and benefit of neoadjuvant therapy among patients undergoing resection for non-small-cell lung cancer. Eur J Cardiothorac Surg 53:656-663
Miller, James A; Harris, Kassem; Roche, Charles et al. (2018) Sarcopenia is a predictor of outcomes after lobectomy. J Thorac Dis 10:432-440
Fenstermaker, Robert A; Figel, Sheila A; Qiu, Jingxin et al. (2018) Survivin Monoclonal Antibodies Detect Survivin Cell Surface Expression and Inhibit Tumor Growth In Vivo. Clin Cancer Res 24:2642-2652
Bhat, Tariq A; Kalathil, Suresh Gopi; Bogner, Paul N et al. (2018) Secondhand Smoke Induces Inflammation and Impairs Immunity to Respiratory Infections. J Immunol 200:2927-2940
Merzianu, Mihai; Groman, Adrienne; Hutson, Alan et al. (2018) Trends in Bone Marrow Sampling and Core Biopsy Specimen Adequacy in the United States and Canada: A Multicenter Study. Am J Clin Pathol 150:393-405

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