Contracts and Budgets

The pre-award process for industry studies includes activities related to contracts and budgets. These activities involve a great deal of customer service to Sponsors, Principal Investigators (PIs), Clinical Research Coordinators (CRCs), and other OSRA staff members. The contract process is facilitated by the Industry Contracts Office (ICO) that resides within OSRA. ICO's core function is to coordinate the various pre-award processes for all industry studies to ensure they are initiated in a timely and efficient manner. The budget process is carried out by a Research Project Analyst, and that person's key objective is to develop and negotiate budgets for all industry studies. A Research Manager oversees the ICO and the Research Project Analyst in the budget area.

Pre-Award Phase

The ICO coordinates the legal review, negotiation, and execution of Confidential Disclosure Agreements (CDAs), Non-Disclosure Agreements (NDAs), and Clinical Trial Agreements (CTAs) for all industry studies. The ICO also tracks the progress of the budget negotiations and regulatory activities to ensure all pre-award processes are complete for each study. Once all components are finalized, the ICO submits a Release of Funds Notice to R&E Finance so that the study can open and begin patient enrollment. The Research Project Analyst completes several steps to develop and industry study budget. First, the analyst develops a draft budget. Once that is complete, the analyst meets with the PI and CRC to review the draft budget and ensure that it accurately projects all the costs associated with the study. Then the analyst corresponds with the Sponsor to negotiate the budget for the study. Once the budget negotiations are finalized, the analyst submits the completed budget to the ICO to be circulated for signatures.

Post-Award Phase

The ICO facilitates the legal review, negotiation, and execution of all amendments to CTAs for industry studies. The Research Project Analyst negotiates and completes all budget amendments for industry studies. Once the budget amendments are finalized, the analyst submits them to the ICO to be circulated for signatures.

Contact Us

Mail Phone Fax
Industry Contracts Office
Research Administration Offices
4236 Lowes Drive
Temple, TX 76508-0001
 888-883-3675  254-771-4892

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