Internal Review of Contract & Budget
Prior to the Kickoff Meeting (KOM), the assigned Clinical Trial Research Process Manager (CT RPM) and Clinical Trial Contract Officer (CT CO) conduct an internal assessment of all documents necessary for budget development and contract review. In order to expedite this review and the subsequent KOM, all required minimum documents should be completely filled out.
Sub Category 1: Internal Review of Budget
The CT RPM reviews the minimum required documents to gain a comprehensive view of how the internal budget should be developed and what items should be included in the budget. During this review, the CT RPM identifies compliance issues, including, but not limited to: billing compliance, Medicare compliance, Good Clinical Practice training, PI Training, PI eligibilty, etc. The CT RPM discusses identified issues with the study team at the Kickoff Meeting.
Sub Category 2: Internal Review of Contract
The CT CO utilizes all minimum, required documents while performing a first pass at contract review and redline. The CT CO identifies any language that needs study team feedback as well as any problematic language requiring escalated review (e.g. Risk Management approval) or could possibly delay the negotiation of the contract (e.g., publication delay). The CT CO discusses identified issues with the study team at the Kickoff Meeting.