Sometimes it is difficult to determine whether to classify an award as a clinical study or as a miscellaneous contract. The following information should be helpful.
Contracts for clinical studies are processed regularly by OSP. A clinical study is identified through these primary factors:
If the study protocol referenced is one presented by a drug company, or the PI is recruited by the drug company to assist with a given protocol, a contract MUST be in place with assurances for the type of study subject involved (e.g. human, animal, etc.).
Miscellaneous contracts are contracts that fund a particular activity, project or individual, but are not clinical studies. The payment method most often identifies these contracts as cost reimbursable, scheduled payments or special billing for which UTHealth must submit invoices in order to be paid.
NOTE: Regardless of the origin of protocol or designation, if patients are involved, CPHS approval is MANDATORY.