The Clinical Research Office (CRO) provides numerous services to faculty and staff conducting oncology research at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) including centralized systems, education, regulatory expertise and quality assurance. Centralized systems are all easily accessible via the CRO website. These systems include an up-to-date protocol library with all approved protocols and consents, a database of all oncology research studies including study accrual and tracking of all IRB submissions, the Clinical Research Review Committee (CRC) Electronic Forum which tracks documents and meeting outcome to support the CRC, a research manual with Standard Operating Procedures, and a pharmacy orders review system for tracking pre-approved orders. Education provided by the CRO includes an introductory research course for all new research staff conducting oncology trials, continuing research education for research faculty and staff, and the """"""""Messenger"""""""" newsletter designed to keep research personnel up-to-date with policies and regulations. The CRO provides regulatory expertise in the area of FDA regulations and Investigational New Drug (IND) submissions, and oversight and guidance for all investigator-initiated, multi-site trials. Quality assurance services are an essential component of the CRO via auditing and monitoring, reviewing adverse events, and developing standard operating procedures. Other services offered to investigators include acting as a liaison with the Johns Hopkins Institutional Review Boards, outside auditors, and the SKCCC External Clinical Trials website manager (to promote open trials to the community). Each SKCCC research Program has a Program manager who has a dual reporting role to both the Research Program Directors and the CRO Manager. In 2004, the CRO received 2,401 submissions (new studies, amendments, SAEs, etc). There were 348 active studies in 2004, 76% intervention in nature. This represents a heavy load in an intense regulatory environment where there i increased scrutiny and continuous interactions with the IRB. Accruals in 2004 equaled 3,121;72% on nonintervention studies and 28% on intervention trials.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA006973-48
Application #
8117664
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
48
Fiscal Year
2010
Total Cost
$764,784
Indirect Cost
Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
Woodard, Lauren E; Dennis, Cindi L; Borchers, Julie A et al. (2018) Nanoparticle architecture preserves magnetic properties during coating to enable robust multi-modal functionality. Sci Rep 8:12706
Shrestha, Eva; White, James R; Yu, Shu-Han et al. (2018) Profiling the Urinary Microbiome in Men with Positive versus Negative Biopsies for Prostate Cancer. J Urol 199:161-171
Gordy, James T; Luo, Kun; Francica, Brian et al. (2018) Anti-IL-10-mediated Enhancement of Antitumor Efficacy of a Dendritic Cell-targeting MIP3?-gp100 Vaccine in the B16F10 Mouse Melanoma Model Is Dependent on Type I Interferons. J Immunother 41:181-189
El-Diwany, Ramy; Soliman, Mary; Sugawara, Sho et al. (2018) CMPK2 and BCL-G are associated with type 1 interferon-induced HIV restriction in humans. Sci Adv 4:eaat0843
Kyker-Snowman, Kelly; Erlanger Avigdor, Bracha; Nasim, Mansoor et al. (2018) A primary breast cancer with distinct foci of estrogen receptor-alpha positive and negative cells derived from the same clonal origin as revealed by whole exome sequencing. Breast Cancer Res Treat 170:425-430
Christenson, Eric S; Antonarakis, Emmanuel S (2018) PARP inhibitors for homologous recombination-deficient prostate cancer. Expert Opin Emerg Drugs 23:123-133
Ambinder, Richard F (2018) A viral protein kinase drug target for tumors? J Clin Invest 128:2197-2198
Lee, Alice J; Montgomery, Madeline C; Patel, Rupa R et al. (2018) Improving Insurance and Health Care Systems to Ensure Better Access to Sexually Transmitted Disease Testing and Prevention. Sex Transm Dis 45:283-286
Bharathy, Narendra; Berlow, Noah E; Wang, Eric et al. (2018) The HDAC3-SMARCA4-miR-27a axis promotes expression of the PAX3:FOXO1 fusion oncogene in rhabdomyosarcoma. Sci Signal 11:
McGrath-Morrow, Sharon A; Ndeh, Roland; Helmin, Kathryn A et al. (2018) DNA methylation regulates the neonatal CD4+ T-cell response to pneumonia in mice. J Biol Chem 293:11772-11783

Showing the most recent 10 out of 2393 publications