- The A-TRU requires a signed Letter of Agreement (LOA) and a copy of the Institutional Review Board (IRB) Approval letter before the study starts.
- Scheduling of Services: Ability to schedule services may be limited by already scheduled services, availability of qualified staff and study room(s).
- Regular hours appointment requests made <48 hours in advance cannot be guaranteed
- After-hours and weekend requests must be made >72 hours in advance
- Requests for off-site services must be made >96 hours in advance
- Cancellation of Requested Services: Please provide notice of at least 24 hours for cancellation of requested services. Cancellations <24 hours and no-shows will be charged the non-refundable visit fee.
- The A-TRU fees are subject to change. Every effort will be made to minimize the amount and frequency of such changes. Notification of impending price changes, except Pass-Through fees, will be relayed via email at least 90 days prior to implementation. It is the responsibility of the study staff and the Principal Investigator to take note of these changes.
- Pass through fees from external contractors (ex. external laboratory fees) are subject to change should the external contractor fees change.
- The A-TRU will bill monthly for all services rendered.
- As a practice, the A-TRU will keep and maintain copies of all study related documents which will be turned over to the Principal Investigator at the time of study closure.
- The PI or the Co-investigator Physician of the study will be available in-house or by telephone during the infusion and observation period.
- If any changes or amendments are made to the protocol, it is the study team’s responsibility to provide updated IRB approval forms and review any procedural changes with the A-TRU staff prior to the next participant’s scheduled visit.
- Should additional services be requested, a new proposal may be created to outline the scope of the request and associated cost-sharing fees. This LOA will be amended as necessary.
- The PI must notify the A-TRU staff when A-TRU services are no longer required (including study completion, closure, or protocol modifications).
- Study withdrawal: Investigators will be billed for all A-TRU services rendered up to the point of withdrawal
On behalf of the department/division/institute or other professional jurisdiction that you represent, you attest that the Principal Investigator is in good standing, approved to devote the proposed time and effort to this project, the Department/Division/Institute endorses the Principal Investigator’s commitment, the project has scientific merit, uses procedures consistent with sound research design, and is likely to yield the expected knowledge.
You agree to cite the CTSA NIH Grant 2UL1TR001436 on all publications arising from any research project receiving support from the CTSI. Publications arising from any research project receiving support from the CTSI must acknowledge such support by stating the following:
“Support received by Grant UL1TR001436 from the Clinical and Translational Science Award (CTSA) program of the National Center for Advancing Translational Sciences”