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.
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.
|Davis, Stacy N; Govindaraju, Swapamthi; Jackson, Brittany et al. (2018) Recruitment Techniques and Strategies in a Community-Based Colorectal Cancer Screening Study of Men and Women of African Ancestry. Nurs Res 67:212-221|
|Martínez, Úrsula; Brandon, Thomas H; Sutton, Steven K et al. (2018) Associations between the smoking-relatedness of a cancer type, cessation attitudes and beliefs, and future abstinence among recent quitters. Psychooncology 27:2104-2110|
|Perales-Puchalt, Alfredo; Perez-Sanz, Jairo; Payne, Kyle K et al. (2018) Frontline Science: Microbiota reconstitution restores intestinal integrity after cisplatin therapy. J Leukoc Biol 103:799-805|
|Nelson, Ashley M; Jim, Heather S L; Small, Brent J et al. (2018) Sleep disruption among cancer patients following autologous hematopoietic cell transplantation. Bone Marrow Transplant 53:307-314|
|Singh, Kshipra; Coburn, Lori A; Asim, Mohammad et al. (2018) Ornithine Decarboxylase in Macrophages Exacerbates Colitis and Promotes Colitis-Associated Colon Carcinogenesis by Impairing M1 Immune Responses. Cancer Res 78:4303-4315|
|Kasting, Monica L; Giuliano, Anna R; Reich, Richard R et al. (2018) Hepatitis C Virus Screening Trends: Serial Cross-Sectional Analysis of the National Health Interview Survey Population, 2013-2015. Cancer Epidemiol Biomarkers Prev 27:503-513|
|Denson, Aaron; Burke, Nancy; Wapinsky, Georgine et al. (2018) Clinical Outcomes of Patients With Gastrointestinal Malignancies Participating in Phase I Clinical Trials. Am J Clin Oncol 41:133-139|
|Betts, Brian C; Bastian, David; Iamsawat, Supinya et al. (2018) Targeting JAK2 reduces GVHD and xenograft rejection through regulation of T cell differentiation. Proc Natl Acad Sci U S A 115:1582-1587|
|Pidala, Joseph; Beato, Francisca; Kim, Jongphil et al. (2018) In vivo IL-12/IL-23p40 neutralization blocks Th1/Th17 response after allogeneic hematopoietic cell transplantation. Haematologica 103:531-539|
|Hampras, S S; Tommasino, M; Zhao, Y et al. (2018) Cross-sectional associations between cutaneous viral infections and regulatory T lymphocytes in circulation. Br J Dermatol :|
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