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.

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Liu, Song; Kumari, Sangeeta; Hu, Qiang et al. (2017) A comprehensive analysis of coregulator recruitment, androgen receptor function and gene expression in prostate cancer. Elife 6:
Wintrob, Zachary A P; Hammel, Jeffrey P; Nimako, George K et al. (2017) Insulin use, hormone receptor status and hematopoietic cytokines? circulation in women with diabetes mellitus and breast cancer. Data Brief 11:382-390
Murphy, Maureen E; Liu, Song; Yao, Song et al. (2017) A functionally significant SNP in TP53 and breast cancer risk in African-American women. NPJ Breast Cancer 3:5
Oakley, Emily; Bellnier, David A; Hutson, Alan et al. (2017) Surface markers for guiding cylindrical diffuser fiber insertion in interstitial photodynamic therapy of head and neck cancer. Lasers Surg Med 49:599-608
Espinal, Allyson C; Buas, Matthew F; Wang, Dan et al. (2017) FOXA1 hypermethylation: link between parity and ER-negative breast cancer in African American women? Breast Cancer Res Treat 166:559-568
Danaher, Patrick; Warren, Sarah; Dennis, Lucas et al. (2017) Gene expression markers of Tumor Infiltrating Leukocytes. J Immunother Cancer 5:18
Szender, J Brian; Papanicolau-Sengos, Antonios; Eng, Kevin H et al. (2017) NY-ESO-1 expression predicts an aggressive phenotype of ovarian cancer. Gynecol Oncol 145:420-425
Gage-Bouchard, Elizabeth A (2017) Social support, flexible resources, and health care navigation. Soc Sci Med 190:111-118
Moore, Kathleen N; Tritchler, David; Kaufman, Kenneth M et al. (2017) Genome-wide association study evaluating single-nucleotide polymorphisms and outcomes in patients with advanced stage serous ovarian or primary peritoneal cancer: An NRG Oncology/Gynecologic Oncology Group study. Gynecol Oncol 147:396-401
Grabosch, Shannon; Tseng, George; Edwards, Robert P et al. (2017) Multiplex profiling identifies distinct local and systemic alterations during intraperitoneal chemotherapy for ovarian cancer: An NRG Oncology/Gynecologic Oncology Group Study. Gynecol Oncol 146:137-145

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