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Use of Investigational Treatments/Trials |
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Manual: Home Care Corporate Compliance Manual (Ver 1) Department: HOME CARE
As the health care industry’s most comprehensive library of customizable policy and procedure templates, MCN Healthcare’s Home Care Corporate Compliance Manual includes this customizable template, Use of Investigational Treatments/Trials. MCN’s policy library helps you meet compliance with Joint Commission and federal regulations including CMS, CDC, OSHA, OIG, HIPAA and more. MCN’s templates save you time, money and resources, rather than developing healthcare policy and procedure manuals from scratch. Here is some sample content from Use of Investigational Treatments/Trials:
| | POLICY:
In the event that a patient is accepted by this organization and is currently enrolled in a clinical drug trial, or the attending physician determines that the patient may benefit from use of an investigational drug or treatment, the physician:
Must submit a request with supporting documentation and investigational protocol to the Executive Director for approval;
Must be approved by the FDA to administer the investigational drug;
Must have an Investigational Drug Informed Consent form signed by the patient and a copy placed in the medical record.
The Pharmacy Department, in... |
| Second excerpt: |
| | ...the FDA to administer the investigational drug;
Must have an Investigational Drug Informed Consent form signed by the patient and a copy placed in the medical record.
The Pharmacy Department, in conjunction with the Medical Director, shall develop all relevant policies and procedures for the handling, storing and distribution of any investigational drugs.
SUBJECT:
USE OF INVESTIGATIONAL TREATMENTS/
REFERENCE #4024
TRIALS
PAGE: 1
DEPARTMENT: HOME CARE
OF: 1
EFFECTIVE:
APPROVED... |
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Back to Home Care Corporate Compliance Manual (Ver 1) |
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