The OHSU Knight Cancer Institute Data and Safety Monitoring Plan (DSMP) follows the policy of the National Cancer Institute for data and safety monitoring of investigator-initiated clinical trials. The purpose of the DSMP is to insure the safety of study participants, the validity of research data and the appropriate termination of studies for which significant benefits or risks have been uncovered or when it appears that the trial cannot be concluded successfully. We also assert that monitoring is a critical instrument for human subjects protection, as it provides investigators direct feedback about their research practices and identifies areas for improvement that can be identified in no other way. It is one of the only mechanisms by which the DSMC can ensure that the study is being conducted in accordance with the IRB and CRRC-approved protocol. When performed in a quality assurance fashion with an educational rather than policing focus, objective monitoring of actual protocol procedures is also one of the most important tools we have to educate investigators on the practical aspects of human subjects protections. Examination of actual research records is the only to way to uncover certain potentially serious compliance issues, such as improperly documented consent, failing to meet eligibility requirements or failure to report adverse events.

Public Health Relevance

The purpose of the DSMP is to insure the safety of study participants, the validity of research data and the appropriate termination of studies for which significant benefits or risks have been uncovered or when it appears that the trial cannot be concluded successfully.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA069533-16
Application #
8504968
Study Section
Subcommittee G - Education (NCI)
Project Start
Project End
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
16
Fiscal Year
2013
Total Cost
$61,306
Indirect Cost
$23,262
Name
Oregon Health and Science University
Department
Type
DUNS #
096997515
City
Portland
State
OR
Country
United States
Zip Code
97239
Le, T Domi; Carney, Patricia A; Lee-Lin, Frances et al. (2014) Differences in knowledge, attitudes, beliefs, and perceived risks regarding colorectal cancer screening among Chinese, Korean, and Vietnamese sub-groups. J Community Health 39:248-65
Ruffell, Brian; Chang-Strachan, Debbie; Chan, Vivien et al. (2014) Macrophage IL-10 blocks CD8+ T cell-dependent responses to chemotherapy by suppressing IL-12 expression in intratumoral dendritic cells. Cancer Cell 26:623-37
Martin, Jessica L; Yates, Phillip A; Soysa, Radika et al. (2014) Metabolic reprogramming during purine stress in the protozoan pathogen Leishmania donovani. PLoS Pathog 10:e1003938
Hitzemann, Robert; Bottomly, Daniel; Iancu, Ovidiu et al. (2014) The genetics of gene expression in complex mouse crosses as a tool to study the molecular underpinnings of behavior traits. Mamm Genome 25:12-22
Liu, Betty Y; O'Malley, Jean; Mori, Motomi et al. (2014) The association of type and number of chronic diseases with breast, cervical, and colorectal cancer screening. J Am Board Fam Med 27:669-81
Affara, Nesrine I; Ruffell, Brian; Medler, Terry R et al. (2014) B cells regulate macrophage phenotype and response to chemotherapy in squamous carcinomas. Cancer Cell 25:809-21
Cope, Leslie M; Fackler, Mary Jo; Lopez-Bujanda, Zoila et al. (2014) Do breast cancer cell lines provide a relevant model of the patient tumor methylome? PLoS One 9:e105545
Caputo, Nicholas; Jackson, Melanie A; Castle, Jessica R et al. (2014) Biochemical stabilization of glucagon at alkaline pH. Diabetes Technol Ther 16:747-58
Yao, Huilan; Goldman, Devorah C; Nechiporuk, Tamilla et al. (2014) Corepressor Rcor1 is essential for murine erythropoiesis. Blood 123:3175-84
Davare, Monika A; Lal, Sangeet; Peckham, Jennifer L et al. (2014) Secreted meningeal chemokines, but not VEGFA, modulate the migratory properties of medulloblastoma cells. Biochem Biophys Res Commun 450:555-60

Showing the most recent 10 out of 88 publications