The Scientific Review Committees (SRC) provide thorough scientific reviews of all protocols to be activated at the Moffitt Cancer Center. Support of the SRC process is the primary focus of the staff within the Protocol Review and Monitoring (OPRM). Specific goals of the PRMS are: ? Appropriate and thorough scientific and statistical review of Moffitt protocols ? Efficient processing and accurate tracking of Moffitt clinical research protocols, and ? Monitoring of scientific progress for ongoing clinical research trials. OPRM support staff process the documents necessary for the review committees and facilitate timely communication of SRC actions between the committee and investigators. All correspondence is saved electronically and noted within the research database (Oncore?). Support staff members also assist investigators in the development of protocol-specific data and safety monitoring plans. The OPRM office maintains an accurate protocol-tracking database for use by the regulatory staff, principal investigators, study teams, and committee members to monitor protocol progress through the review processes, including SRC and IRB review, budgeting, and contracting as appropriate, and an operational review process to allow ancillary departments to review and sign off on protocol feasibility. Other OPRM staff members assist Moffitt investigators with efficient, accurate review and processing of research protocols and submission to the IRB for human subject approval and work with monitors in the data and safety monitoring process. Moffitt has committees that perform scientific review, each meeting monthly. Two committees review clinical research proposals, while the third committee reviews tissue and data studies. Meeting dates are staggered to allow for SRC meetings approximately every 10 days. The three SRCs provide the initial scientific peer review of the protocol and monitor these protocols throughout the term of the study for scientific progress (e.g., meeting accrual goals) and for changes that might impact the objectives of the study. The PRMS requests CCSG Support of $247,671, which is 28% of its operational budget.

Public Health Relevance

The Protocol Review and Monitoring System (PRMS) monitors all clinical and translational trials to provide Moffitt investigators with efficient, accurate review and processing of research protocols and submission to the IRB for human subject approval and work with monitors in the data and safety monitoring process. The PRMS is essential in providing infrastructure and support for conducting clinical research.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA076292-15
Application #
8495982
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-02-01
Budget End
2014-01-31
Support Year
15
Fiscal Year
2013
Total Cost
$138,630
Indirect Cost
$56,358
Name
H. Lee Moffitt Cancer Center & Research Institute
Department
Type
DUNS #
139301956
City
Tampa
State
FL
Country
United States
Zip Code
33612
Tauro, Marilena; Shay, Gemma; Sansil, Samer S et al. (2017) Bone-Seeking Matrix Metalloproteinase-2 Inhibitors Prevent Bone Metastatic Breast Cancer Growth. Mol Cancer Ther 16:494-505
Davis, Stacy N; Christy, Shannon M; Chavarria, Enmanuel A et al. (2017) A randomized controlled trial of a multicomponent, targeted, low-literacy educational intervention compared with a nontargeted intervention to boost colorectal cancer screening with fecal immunochemical testing in community clinics. Cancer 123:1390-1400
Song, Jinming; Hussaini, Mohammad; Zhang, Hailing et al. (2017) Comparison of the Mutational Profiles of Primary Myelofibrosis, Polycythemia Vera, and Essential Thrombocytosis. Am J Clin Pathol 147:444-452
Strom, Tobin; Harrison, Louis B; Giuliano, Anna R et al. (2017) Tumour radiosensitivity is associated with immune activation in solid tumours. Eur J Cancer 84:304-314
Heit, Claire; Marshall, Stephanie; Singh, Surrendra et al. (2017) Catalase deletion promotes prediabetic phenotype in mice. Free Radic Biol Med 103:48-56
Eksioglu, E A; Chen, X; Heider, K-H et al. (2017) Novel therapeutic approach to improve hematopoiesis in low risk MDS by targeting MDSCs with the Fc-engineered CD33 antibody BI 836858. Leukemia 31:2172-2180
Kamath, Vidya P; Torres-Roca, Javier F; Eschrich, Steven A (2017) Integrating Biological Covariates into Gene Expression-Based Predictors of Radiation Sensitivity. Int J Genomics 2017:6576840
Liu, Ying; Balagurunathan, Yoganand; Atwater, Thomas et al. (2017) Radiological Image Traits Predictive of Cancer Status in Pulmonary Nodules. Clin Cancer Res 23:1442-1449
Chen, Yi; Fisher, Kate J; Lloyd, Mark et al. (2017) Multiplexed Liquid Chromatography-Multiple Reaction Monitoring Mass Spectrometry Quantification of Cancer Signaling Proteins. Methods Mol Biol 1647:19-45
Extermann, Martine; Leeuwenburgh, Christiaan; Samiian, Laila et al. (2017) Impact of chemotherapy on medium-term physical function and activity of older breast cancer survivors, and associated biomarkers. J Geriatr Oncol 8:69-75

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