The Central Protocol and Data Monitoring Office (CPDMO) within the St. Jude Comprehensive Cancer Center (SJCCC) provides centralized, administrative, regulatory and educational services to SJCCC members for the conduct of clinical trials-related activities. It is the main coordinating center for protocol development, regulatory and compliance guidance, administrative submissions, protocol registration data, and quality assurance, including monitoring. The overarching goal of the CPDMO is to provide outstanding clinical trials support to SJCCC clinical investigators by: (1) facilitating the development of high quality clinical research trials, within a standardized frame work of trial development and content, so that all appropriate institutional and Federal requirements are met prior to accruing participants; (2) maintaining a centralized submission process for institutional review and approval (CT-SRC and the IRB); (3) ensuring appropriate standards of clinical trials across the institution by encouraging consistent trial conduct and regulatory compliance through the monitoring of trials; (4) ensuring appropriate research participant enrollment via a centralized clinical trial registration system; (5) providing appropriate infrastructure and coordination for clinical trials at our affiliate and collaborating institutions; and (6) adhering to the Data Safety Monitoring Plan approved by the NCI in August 2010. In addition, the CPDMO provides administrative support to the CTSRC to ensure appropriate scientific review of all clinical trials at the SJCCC. Clinical trials are monitored commensurate with the degree of risk involved in study subject participation, as well as the size and complexity of the study. Our position is that trial monitoring and safety reporting is a shared responsibility across all members in the clinical trial process, each having different roles and responsibilities (the Institution and the Principal Investigators and study team(s), oversight committees, monitors, etc.). Particular attention is paid to monitoring investigator-initiated clinical trials, especially those for which there is no independent outside monitoring program.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA021765-39
Application #
9439726
Study Section
Subcommittee I - Transistion to Independence (NCI)
Project Start
Project End
Budget Start
2018-03-01
Budget End
2019-02-28
Support Year
39
Fiscal Year
2018
Total Cost
Indirect Cost
Name
St. Jude Children's Research Hospital
Department
Type
DUNS #
067717892
City
Memphis
State
TN
Country
United States
Zip Code
38105
van Oosterwijk, Jolieke G; Buelow, Daelynn R; Drenberg, Christina D et al. (2018) Hypoxia-induced upregulation of BMX kinase mediates therapeutic resistance in acute myeloid leukemia. J Clin Invest 128:369-380
Howell, Carrie R; Wilson, Carmen L; Ehrhardt, Matthew J et al. (2018) Clinical impact of sedentary behaviors in adult survivors of acute lymphoblastic leukemia: A report from the St. Jude Lifetime Cohort study. Cancer 124:1036-1043
Zamora, Anthony E; Crawford, Jeremy Chase; Thomas, Paul G (2018) Hitting the Target: How T Cells Detect and Eliminate Tumors. J Immunol 200:392-399
Zhong, Bo; Maharaj, Anil; Davis, Abigail et al. (2018) Development and validation of a sensitive LC MS/MS method for the measurement of the checkpoint kinase 1 inhibitor prexasertib and its application in a cerebral microdialysis study. J Pharm Biomed Anal 156:97-103
Upadhyaya, Santhosh A; Robinson, Giles W; Harreld, Julie H et al. (2018) Marked functional recovery and imaging response of refractory optic pathway glioma to BRAFV600E inhibitor therapy: a report of two cases. Childs Nerv Syst 34:605-610
Goldsby, Robert E; Stratton, Kayla L; Raber, Shannon et al. (2018) Long-term sequelae in survivors of childhood leukemia with Down syndrome: A childhood cancer survivor study report. Cancer 124:617-625
Howell, Carrie R; Krull, Kevin R; Partin, Robyn E et al. (2018) Randomized web-based physical activity intervention in adolescent survivors of childhood cancer. Pediatr Blood Cancer 65:e27216
Cherian, Milu T; Chai, Sergio C; Wright, William C et al. (2018) CINPA1 binds directly to constitutive androstane receptor and inhibits its activity. Biochem Pharmacol 152:211-223
Hoehn, Mary Ellen; Calderwood, Julie; Gannon, Edwin et al. (2018) Ocular complications in a young pediatric population following bone marrow transplantation. J AAPOS 22:102-106.e1
Devine, Katie A; Mertens, Ann C; Whitton, John A et al. (2018) Factors associated with physical activity among adolescent and young adult survivors of early childhood cancer: A report from the childhood cancer survivor study (CCSS). Psychooncology 27:613-619

Showing the most recent 10 out of 6764 publications