The University of Colorado Cancer Center’s (CU Cancer Center) Data and Safety Monitoring Plan helps ensure safety and ethical treatment of all human subjects participating in research and verifies that all collected data is accurate, complete, valid and has integrity.
The CU Cancer Center Data and Safety Monitoring Committee (DSMC):
- Oversees all aspects of QA/DSM within the CU Cancer Center
- Reports to the CU Cancer Center Executive Committee and the Colorado Multiple Institutional Review Board (COMIRB)
- Reviews and tracks all serious adverse events (SAEs), unanticipated problems (UAPs), and other reportable adverse events (AEs) identified and reported by the CU Cancer Center
The DSM Committee identifies, develops and offers a variety of instructional activities to Principal Investigators and Co-Investigators to improve knowledge of and compliance with clinical trials management standards.
The Cancer Clinical Trials Office (CCTO) collaborates with COMIRB, CU Denver Associate Vice Chancellor for Compliance, the School of Medicine Clinical Trials Advisory Committee, University of Colorado Hospital Research Review Committee and others to make the clinical trials process more efficient and accurate.
The DSMC is a requirement of the National Cancer Institute (NCI) and is intended to function as a helpful support team. For further information on the DSMC, please email DSMC@ucdenver.edu.
Protocol Development Support Services
In support of investigator initiated research at the CU Cancer Center, the DSMC has developed template language for the data and safety monitoring component required within all interventional investigator initiated trial protocols. These templates are available under DOCUMENT DOWNLOADS on the left hand side of this page. Below are the steps that need to be taken in order to properly use these templates:
- Select the template that corresponds to the phase (or tissue bank) of the protocol under development
- Review the template language
- Make any modifications (as needed) to this language based on the protocol’s needs or risks
- Insert the data and safety monitoring plan language within the protocol
- Submit the final protocol to the Protocol Review & Monitoring System (PRMS) through the PRMS protocol submission process
- Obtain DSMC approval within the PRMS SRC approval notification
Please note that the template language is meant to serve as a guide when developing the data and safety monitoring component of the investigator initiated protocol, and is NOT meant to serve as a substitute for the protocol. Investigators are encouraged to review the template language and make modifications as needed prior to inserting the language into their protocol. If there are any questions regarding the template language, or the development of a protocol specific data and safety monitoring plan please contact the DSMC at DSMC@ucdenver.edu.
Six Month Data Safety Monitoring Reports for Investigator Initiated Trials
Principal Investigators of investigator initiated interventional clinical trials not monitored by a data and safety monitoring board or committee are required to complete and submit a Data Safety Monitoring (DSM) report to the DSMC every 6 months. This is a requirement from the FDA and the NCI to ensure that there is appropriate oversight for investigator initiated trials sponsored by the CU Cancer Center. This does not include cooperative group trials or trials where the CU Cancer Center is not the coordinating center and the coordinating center is providing oversight.
The 6 Month DSM Report Template is available under DOCUMENT DOWNLOADS on the left hand side of this page. If you are holding the IND locally for a trial, the report submitted to the FDA can be substituted.
These reports should be submitted every 6 months beginning 6 months after the first patient is enrolled, and due on the first of the month that the DSMC meets. The DSMC meets quarterly in January, April, July and October, so reports will be due January 1st, April 1st, July 1st and October 1st. This DSM reporting cycle may align with the annual IRB continuing review of the trial; therefore the 6 month DSM reporting cycle may be adjusted in order to allow for DSMC review and approval prior to continuing review submission. Please contact the DSMC at DSMC@ucdenver.edu regarding any reporting cycle questions or adjustments.
|Jennifer Diamond, MD
|Astrid Eder, PhD
||Senior Regulatory Analyst
|Christine Fisher, MD
|Lia Gore, MD
|Colleen Kellackey, RN
||Clinical Operations Manager
|Elaine Lam, MD
|Stephen Leong, MD
|Jan Bullock, RN, BSN
|Adam Poust, PharmD
|Dexiang Gao, PhD
|Edward Bedrick, PhD
|Bryan McNair, MS
|Andrew Wise, BA
|Lisa Haney, BS, CCRC
|Antonio Jimeno, MD, PhD
|Thomas Flaig, MD