DATA AND SAFETY MONITORING The Data and Safety Monitoring Plan (DSMP) of the Kimmel Cancer Center (KCC) provides for the oversight and monitoring of clinical trials to ensure the: 1. Safety of patients;and 2. Validity and integrity of the data collected on these trials. Responsibility for data and safety monitoring at Thomas Jefferson University (TJU) resides in: 1. The Clinical Cancer Research Review Committee (CCRRC) which oversees the scientific review of all new and ongoing cancer-related clinical trials within the KCC; 2. The Clinical Research Management Office (CRMO) which provides strategic assistance and support to the CCRRC, DSMC, and continuous monitoring; 3. The Institutional Review Board (IRB) which has primary responsibility for the protection of the welfare of human subjects involved in biomedical and behavioral research. The IRB has full authority to approve, request modifications prior to approval, disapprove, suspend, or terminate for cause all research activities that fall within its jurisdiction;and 4. The Data and Safety Monitoring Committee (DSMC), which is responsible for data and safety monitoring of Kimmel Cancer Center investigator-initiated trials (KCC IIT).

Public Health Relevance

The DSMP requires that every Kimmel Cancer Center protocol include a data and safefy monitoring plan. The CCRRC will not review a study that does not have such a plan, and the TJU IRB will not accept a study for review and approval until it has been approved by the CCRRC

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Center Core Grants (P30)
Project #
5P30CA056036-15
Application #
8753675
Study Section
Subcommittee B - Comprehensiveness (NCI)
Project Start
Project End
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
15
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Thomas Jefferson University
Department
Type
DUNS #
City
Philadelphia
State
PA
Country
United States
Zip Code
19107
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