When is it a Clinical Trial
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.
Clinical Studies: Fund 57001
Contracts for clinical studies are processed regularly by OSP. A clinical study is identified through these primary factors:
- It is a study using human subjects or animals for research.
- Drugs or medical devices are being utilized.
- Typically, payment is made on a per-study-subject basis (rather than cost reimbursement basis).
- Typically, payments are generally not scheduled (not received monthly or quarterly in predetermined amounts).
- Typically, there are no spending restrictions.
- Typically, the University keeps any unspent/residual the funds.
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: Fund 57015
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.