The RPCI Clinical Protocol and Data Management/Clinical Trials Office (CPDM) is a comprehensive resource that provides a full range of clinical research services for all RPCI investigators at all RPCI clinical sites and in the clinical sites of its affiliates. CPDM is directed by Joyce Yasko, PhD, with Assistant Director Laurie Musial RN, MS and overseen by Alex Adjei, MD, PhD, Associate Director for Clinical Research. CPDM provides resources and oversight for the development, review, implementation, and conduct of clinical research studies and tracks regulatory documents. In collaboration with the study principal investigator, CPDM submits studies and amendments to the Scientific Review Committee (SRC) and Institutional Review Board (IRB) and submits continuing reviews to the IRB. CPDM also provides administrative support for the Clinical Research Prioritization and Feasibility Committee (CRPC), Scientific Review Committee (SRC), Response Review Committee (RRC), Phase I Committee and the Data and Safety Monitoring Board (DSMB). CPDM prepares, negotiates and manages study budgets and contracts; provides study sponsors and regulatory agencies with all required study documents;coordinates the conduct of all RPCI clinical studies and ensures that complete and accurate study data are collected and entered into a centralized electronic research database (eClinical). CPDM also ensures that all adverse events are reported promptly and accurately. In CY 2012, CPDM managed 213 active intervention studies with an accrual of 870 participants (1235 consented accrual) and 256 non-intervention studies with an accrual of 591,727 participants. The RPCI Data &Safety Monitoring Board (DSMB) coordinates and provides oversight for data and safety monitoring for all treatment intervention studies consistent with the NIH Policy for Data and Safety Monitoring dated June 10, 1998. The revised Roswell Park Cancer Institute Data &Safety Monitoring Plan (DSMP) was approved by the National Cancer Institute on April 4, 2011

Public Health Relevance

The Clinical Protocol and Data Management (CPDM) office provides the necessary infrastructure to conduct clinical investigations and to translate the basic research at Roswell Park Cancer Institute into cancer-relevant clinical studies.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
2P30CA016056-37
Application #
8738372
Study Section
Subcommittee G - Education (NCI)
Project Start
1997-06-16
Project End
2019-04-30
Budget Start
2014-06-26
Budget End
2015-04-30
Support Year
37
Fiscal Year
2014
Total Cost
$231,955
Indirect Cost
$91,748
Name
Roswell Park Cancer Institute Corp
Department
Type
DUNS #
824771034
City
Buffalo
State
NY
Country
United States
Zip Code
14263
Irons, Eric E; Lau, Joseph T Y (2018) Systemic ST6Gal-1 Is a Pro-survival Factor for Murine Transitional B Cells. Front Immunol 9:2150
Chen, George L; Hahn, Theresa; Wilding, Gregory E et al. (2018) Reduced-Intensity Conditioning with Fludarabine, Melphalan, and Total Body Irradiation for Allogeneic Hematopoietic Cell Transplantation: The Effect of Increasing Melphalan Dose on Underlying Disease and Toxicity. Biol Blood Marrow Transplant :
Khoury, Thaer; Gaudioso, Carmelo; Fang, Yisheng V et al. (2018) The role of skin ulceration in breast carcinoma staging and outcome. Breast J 24:41-50
Griffiths, Elizabeth A; Srivastava, Pragya; Matsuzaki, Junko et al. (2018) NY-ESO-1 Vaccination in Combination with Decitabine Induces Antigen-Specific T-lymphocyte Responses in Patients with Myelodysplastic Syndrome. Clin Cancer Res 24:1019-1029
Hanif, Ahmad; Wang, Eunice S; Thompson, James E et al. (2018) Combining blinatumomab with targeted therapy for BCR-ABL mutant relapsed/refractory acute lymphoblastic leukemia. Leuk Lymphoma 59:2011-2013
Travers, Mark J; Kulak, Jessica A; Vogl, Lisa (2018) Waterpipe caf├ęs are hazardous to your health: Determination of a waterpipe specific calibration factor. Int J Hyg Environ Health 221:48-53
Khoury, Thaer; Nagrale, Vidya; Opyrchal, Mateusz et al. (2018) Prognostic Significance of Stromal Versus Intratumoral Infiltrating Lymphocytes in Different Subtypes of Breast Cancer Treated With Cytotoxic Neoadjuvant Chemotherapy. Appl Immunohistochem Mol Morphol 26:523-532
Yang, Lu; Bhattacharya, Arup; Li, Yun et al. (2018) Anticoagulants inhibit proteolytic clearance of plasma amyloid beta. Oncotarget 9:5614-5626
Welliver, R Ross; Polanco, Jessie J; Seidman, Richard A et al. (2018) Muscarinic receptor M3R signaling prevents efficient remyelination by human and mouse oligodendrocyte progenitor cells. J Neurosci :
Widman, Christy A; Rodriguez, Elisa M; Saad-Harfouche, Frances et al. (2018) Clinician and Parent Perspectives on Educational Needs for Increasing Adolescent HPV Vaccination. J Cancer Educ 33:332-339

Showing the most recent 10 out of 1555 publications