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.
The overall goals of the CPDMO and the Data and Safety Monitoring Plan are to support Cancer Center clinical investigators, and to provide an environment conducive to maintaining the highest standards and measures in clinical research and data integrity while upholding the safety and well-being of our trial participants.
|ElInati, Elias; Russell, Helen R; Ojarikre, Obah A et al. (2017) DNA damage response protein TOPBP1 regulates X chromosome silencing in the mammalian germ line. Proc Natl Acad Sci U S A 114:12536-12541|
|Gibson, Todd M; Li, Zhenghong; Green, Daniel M et al. (2017) Blood Pressure Status in Adult Survivors of Childhood Cancer: A Report from the St. Jude Lifetime Cohort Study. Cancer Epidemiol Biomarkers Prev 26:1705-1713|
|Scott, Daniel C; Hammill, Jared T; Min, Jaeki et al. (2017) Blocking an N-terminal acetylation-dependent protein interaction inhibits an E3 ligase. Nat Chem Biol 13:850-857|
|Patel, Y T; Daryani, V M; Patel, P et al. (2017) Population Pharmacokinetics of Selumetinib and Its Metabolite N-desmethyl-selumetinib in Adult Patients With Advanced Solid Tumors and Children With Low-Grade Gliomas. CPT Pharmacometrics Syst Pharmacol 6:305-314|
|Penkert, Rhiannon R; Jones, Bart G; Häcker, Hans et al. (2017) Vitamin A differentially regulates cytokine expression in respiratory epithelial and macrophage cell lines. Cytokine 91:1-5|
|Howell, Carrie R; Wilson, Carmen L; Ehrhardt, Matthew J et al. (2017) Clinical impact of sedentary behaviors in adult survivors of acute lymphoblastic leukemia: A report from the St. Jude Lifetime Cohort study. Cancer :|
|Talleur, Aimee C; Triplett, Brandon M; Federico, Sara et al. (2017) Consolidation Therapy for Newly Diagnosed Pediatric Patients with High-Risk Neuroblastoma Using Busulfan/Melphalan, Autologous Hematopoietic Cell Transplantation, Anti-GD2 Antibody, Granulocyte-Macrophage Colony-Stimulating Factor, Interleukin-2, and Hapl Biol Blood Marrow Transplant 23:1910-1917|
|Wu, Jianrong (2017) Single-Arm Phase II Survival Trial Design Under the Proportional Hazards Model. Stat Biopharm Res 9:25-34|
|Svolos, P; Reddick, W E; Edwards, A et al. (2017) Measurable Supratentorial White Matter Volume Changes in Patients with Diffuse Intrinsic Pontine Glioma Treated with an Anti-Vascular Endothelial Growth Factor Agent, Steroids, and Radiation. AJNR Am J Neuroradiol 38:1235-1241|
|Lin, Wenwei; Goktug, Asli N; Wu, Jing et al. (2017) High-Throughput Screening Identifies 1,4,5-Substituted 1,2,3-Triazole Analogs as Potent and Specific Antagonists of Pregnane X Receptor. Assay Drug Dev Technol 15:383-394|
Showing the most recent 10 out of 6607 publications