Allows the PI to realistically assess the cost of doing clinical trials

• Separates Routine Clinical Care Costs (RC) from Protocol Induced Costs (PIC), ensuring PI and institutional compliance with state and federal regulations
• Provides documentation that allows for quality monitoring and audit of clinical trial/research finances.

 

To obtain a Budget Workbook, email the following documents to octrclinicaltrial@uchc.edu:

• Study protocol, including schema of patient events
• Study budget, as proposed by sponsor
• Informed consent form or sponsor template, if final form is not available
• Completed OCTR Dental Preliminary Budget Workbook Packet
• After all of the above documents have been received, a budget meeting will be scheduled with OCTR staff and study coordinator, PI, and department administrator/billing coordinator. This group will verify all necessary procedures, CPT codes, as well as time and effort (T&E) required for the study.

The completed Budget Workbook will be emailed to the PI, study coordinator and department administrator or billing coordinator within seven working days of the Budget Workbook meeting and the submission of all necessary information.

The PI should review all procedure codes and time and effort (T&E) allocations. Signed confirmation of review must be sent back to OCTR with recommended changes or verification of accuracy. When Budget Workbook is final, a memo will be sent to the IRB, indicating that the requirement to complete a Budget Workbook has been fulfilled. The memo can be issued even is budget negotiations are still in progress. The IRB will then accept the study application for review.

If a study does not generate clinical charges, a letter of exemption will be issued by OCTR for the IRB submission.