Industry Clinical Trial Agreement (CTA) process summary

Summary of industry funded Clinical Trial Agreement (CTA) process

1. Upon receipt of a contract or request to draft a contract, an Office of Research Contracts (ORC) Agreement Manager will send an email to the Principal Investigator (PI) and, as applicable, either the Clinical Research Unit (CRU) Financial Practice Manager (FPM), budget negotiator, and the study coordinator, or Dept. Business Manager/Grants Manager. This email will identify the agreement manager handling the contract, and provide general information on what to expect.
2. The ORC Agreement Manager will seek to use a Master Agreement, language or templates previously agreed upon by the other party, or a modified ACTA (Accelerated Clinical Trial Agreement) in all contract negotiations.  
3. The ORC Agreement Manager will route an agreement for signatures when the SPS record is Pending Central Approval (PCA), the CRU/Dept confirms the budget and payment terms in the execution copy are approved and consistent with the School of Medicine policy, and any additional requested documents (such as an insurance certificate) have been received.