The UNM Cancer Center places the highest priority on ensuring the safety of patients participating in clinical trials. All clinical trials require monitoring commensurate with the degree of risk involved in participation of studies. Data and safety monitoring activities for each study continue until all patients have completed their treatment and all patients are beyond the time point at which study-related adverse events would likely be encountered. The UNM Cancer Center has implemented a process for routine data monitoring and safety review which takes into account National Cancer Institute (NCI) guidelines;

1. Monitoring the progress of trials and the safety of participants
2. Plans for assuring compliance with requirements regarding the reporting of adverse events (AEs)
3. Plans for assuring that any action resulting in a temporary or permanent suspension of an NCI-funded clinical trial is reported to the NCI grant program director responsible for the grant
4. Plans for assuring data accuracy and protocol compliance, including minimization of risks
The data safety monitoring plan describes and details the processes in place to assure successful implementation of the above guidelines. The addendums include the information and forms necessary to carry out the program.

E-Velos eResearch Database

Internal Site Initiations

An internal site initiation for institutional studies, cooperative studies or any study that does not have a sponsor initiation is required prior to opening a study for enrollment. Internal site initiations are scheduled according to pending approval status.

The initiations are scheduled for Monday’s, 7:30am, in room B-32. The primary research team is required to attend. The PI is required to prepare and deliver the initiation presentation. A standard presentation format has been prepared, however, it is optional. The Research Coordinator from the NMCCA attends study initiations which are open to Alliance sites to communicate and educate the sites. The site initiation objectives include;

• Presentation of the protocol
• Opportunity to answer questions
• Review of the study calendars
• Completing required signature logs
• Review and set up of standard chemotherapy orders (if applicable)
• Uploading forms to Evelos to be used during the study
• Uploading presentation to Evelos for access by Alliance members (if applicable)

A Principal Investigator may exchange dates with a colleague, just as you would exchange call duties. This requires a minimum of a two (2) week notice.

Standard Presentation (Must save document to use)

Current Schedule of Internal Site Initiations

Protocol Monitoring Committee

The PMC acts as or designates a Data Safety Monitoring Board for studies approved by the PRC and the MSRC unless otherwise specified by this plan. The PMC will review and monitor all study progress. If appropriate, the PMC will designate and monitor corrective action(s) based on review findings. The PMC will have the authority of amending and terminating protocols.

• Protocol Monitoring Committee bylaws: word | pdf
• PMC roster word | pdf

2009 Standard Operating Procedures
Clinical Trial Office (CTO)

All clinical studies supported by the CTO must be carried out according to International Conference on Harmonization (ICH) / WHO Good Clinical Practice standards, regulatory authorities requirements, and Standard Operating Procedures (SOPs). All members of the research team are required to follow and adhere to SOP's. Each SOP describes a procedure or process carried out in the management of a study or general administration and education of the clinical trials.

The following SOP's have been developed, reviewed or revised by the Clinical Trial Office Executive Council as of September 21, 2009. The Annual Summary details the review of each SOP.  If a process has been developed or revised the summary specifies this information.    A minimum required review by staff column provides a guide for Managers and Supervisors.

The SOP's are reviewed on at a minimum on a biennial basis in accordance with SOP 1.1. If a new process is developed a new SOP is developed at that time and approved by the CTO Executive Council.  Relevant Research Team Members are notified and required to review the SOP. New or revised SOP's are in bold.

If you have questions regarding the SOP's please contact the Office of Quality Assurance at 272-4974.     

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