Investigator-Intitiated Studies
The CRI is charged by the TTUHSC President with facilitating an increase in investigator-initiated research involving full-time faculty, fellows, residents and medical students. This research can include trials with patients, chart reviews, surveys, etc. The CRI staff provides assistance in defining projects, developing experimental protocols, preparing budgets, developing Institutional Review Board (IRB) submissions and conducting the study. We also provide training at each step.
The CRI study coordinators will provide assistance at all levels but will not be expected to complete a study without involvement of the investigators. The CRI reserves the right to discontinue studies that are not progressing for any length of time or in which the investigators have no involvement.
Principal investigators (PIs) must be full-time faculty, but the participation of fellows, residents and students as co-investigators are encouraged.
All the services of the CRI for investigator-initiated projects are free of charge to the investigator. Any other expenses such as lab tests, supplies, etc. must be borne by the investigator's department or other sources. There must be documentation that these expenses will be covered prior to approval of the study. Seed grants may be used as a source of such funds.
Industry-Sponsored Clinical Trials
Because of the emphasis being placed on investigator-initiated clinical trials, the number of industry-sponsored trials currently active and the number of study coordinators at this time, new industry-sponsored clinical trials will be coordinated by the CRI only under the following rigorous conditions:
- The required number of subjects will be available and can be enrolled in the defined time period
- Inclusion/exclusion criteria are not so strict as to severely restrict enrollment. The nature of expected subject participation is not such as to discourage enrollment
- CRI study coordinators have sufficient time to take on the study
- No monetary support will come from the CRI. The budget and contract will be negotiated as done previously. If the CRI incurs costs above that budgeted (including salary costs for the time spent by the nurse coordinator), these must be covered and paid immediately by the sponsoring department or CRI support will be terminated and study completion turned over to the department
- The principal investigator agrees to meet his/her responsibilities for participation on the study
- The application form must be submitted to the CRI with the signature of the department chair certifying their approval of the study and agreement to assume costs when revenues exceed expenses
- The study must be approved by the co-directors of the CRI
When the CRI is unable to take on additional industry-sponsor trials, the CRI is willing to hire, train and supervise a new study coordinator whose salary and training fee will be paid up front as agreed to by the sponsoring department as defined in an internal Memorandum of Understanding (MOU).
For questions regarding Industry-related Contracts, please contact:
Pam Frazier, MPA, CCRP
Contracting, Senior Director
T: 806.743.4367
pamela.frazier@ttuhsc.edu