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Investigational Drugs Study Requirements

Definition

Date of Last Review 12/15/2011
SME: Director of Research


Investigational drugs include those substances in clinical stages of evaluation that the Food and Drug Administration has not yet released for distribution.

Requirements before starting research

The investigator must follow these guidelines before conducting research:

Submit the protocol to the following:

Committee for Protection of the Human Subjects

Pharmacy and Therapeutic Committee of UTHCPC

UTHCPC Research Committee

Consult the Director of Pharmacy Services or designee

Requirements after starting research

The investigator must follow these guidelines after starting the research:

Use the investigational drugs only in accordance with the procedure described in the protocol approved by CPHS

Supervise the usage of the investigational drugs

Not give an investigational drug for use to any of the following:

A patient not under his immediate supervision

Another physician not responsible to him/her

A patient not part of the research

A physician in another institution

Inclusion in master treatment plan

The master treatment plan will include the research protocol documentation.

Related Standard

The Joint Commission: Rights and Responsibilities of the Individual

 

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Harris County Psychiatric Center University of Texas Health Science Center