Data and Safety Monitoring Committee 

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 trial 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


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 in the table below and correspond with the trial types listed under the "Trial Description" column.  The following steps need to be taken in order to obtain and use these templates:

  1. Identify the trial type of the protocol in development in the table below that best matches one of the categories under the "Trial Description" column
  2. Click on the description as it is a link to the template language
  3. Review the template language
  4. Make any modifications (as needed) to this language based on the protocol’s needs or risks
  5. Insert the data and safety monitoring plan language within the protocol
  6. Submit the final protocol to the Protocol Review & Monitoring System (PRMS) through the PRMS protocol submission process 
  7. 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 Template Language

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 regarding any reporting cycle questions or adjustments.

Committee Members

Peter Kabos, MDAssociate ProfessorMedical Oncology
Christine Fisher, MDAssociate ProfessorRadiation Oncology
Alisa Lee-Sherick, MDAssistant ProfessorPediatric Hematology/Oncology
​Elizabeth Kessler, MDAssistant ProfessorMedical Oncology
​Tomer Mark, MD, MScAssociate ProfessorHematology/BMT
​Theresa Medina, MDAssistant ProfessorMedical Oncology
Steven Schuster, MDAssistant ProfessorHematology/Medical Oncology
Ana Gleisner, MDAssistant ProfessorSurgical Oncology
Elena Shagisultanova, MDAssistant ProfessorMedical Oncology
Naga Venkata Iruku, MDPhysicianHematology/Medical Oncology
​Adam Poust, PharmD​Pharmacy ManagerInvestigational ​Pharmacy
Melinda Friesleben, PharmD​Pharmacist​Investigational ​Pharmacy
Anna Blomberg, Pharm DPharmacistInvestigational ​Pharmacy
Danielle Salaz, Pharm DPharmacistInvestigational ​Pharmacy
Therese Henry, PharmD​Pharmacist​Investigational ​Pharmacy

Diana Abbott, PhD, MS

Research Associate​Biostatistics
Andrew Hammes, MSResearch InstructorBiostatistics
Andrew Wise, BA, CCRA​​​DSMC Program DirectorData Safety Management 
Lara Sprague, MA, CCRPDSMC AuditorData Safety Management 
Anna-Marie Locher, BS, CCRCDSMC Senior AuditorData Safety Management 
Jose Velez, PhDDSMC Senior AuditorData Safety Management 


Contact Us

Data Safety and Monitoring Committee