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Investigational Drugs Research Documentation

 

Date of Last Review 4/08/10
Date of Last Review 12/15/2011
SME:
Director of Research

Research assistants

Research assistants must comply with the following:

Do not document in the patient's medical record

Complete the Research Information Request form

Notify the following when a patient is included in a study:

Research Intermediary (if indicated)

Research Department

Discontinuation of a protocol

If the patient decides to discontinue a protocol, the attending physician does the following:

Writes an order to discontinue the protocol

The attending physician writes the following in the progress notes:

His/her discussion with the patient

The exact date and time

The withdrawal procedure

The remaining hospitalization plans

Written orders requirements

The attending physician does the following:

Writes orders

Co-signs any order that a resident or non-attending physician investigator writes for research studies prior to transcription by Nursing.

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