Tenn. Comp. R. & Regs. 1140-14-.13
The pharmacist in charge in coordination with the long-term care facility, medical and nursing staff and, if appropriate, the pharmaceutical manufacturer, shall develop policies and procedures for the approval, management, distribution and control of investigational drug studies. The process shall ensure that such studies contain safeguards for the patient, for the long-term care facility and for the scientific integrity of the study. Each patient or the patient's legal guardian must freely consent, in writing, to treatment with the drugs, unless otherwise not required by federal law. The pharmacist is responsible to the long-term care facility and to the principal investigator for seeing that procedures for the control of investigational drugs are developed and implemented when needed.
Tenn. Comp. R. & Regs. 1140-14-.13
Authority: T.C.A. § 63-10-304.