Manual: Administrative Manual for Ambulatory Care Facilities (Ver 8) External Reference: "(JC EC.2.180, MM.7.40)(AAAHC 22-A)"
MCN's customizable template, Use of Investigational Treatments/Trials, is taken from our Administrative Manual for Ambulatory Care Facilities. MCN Healthcare's proven policy and procedure templates, competencies and compliance tools have assisted more than 20,000 health care organizations worldwide meet their regulatory compliance goals. Health care organizations around the world utilize MCN's compliant ready templates and workflow process tools to help them meet the latest changes in regulations and standards. Here is some sample content from Use of Investigational Treatments/Trials:
| | POLICY:
In the event that a patient seeks treatment at this facility 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 Medical 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: |
| | ...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 staff, shall develop all relevant policies and procedures for the handling, storing and distribution of any investigational drugs.
SUBJECT:USE OF INVESTIGATIONALREFERENCE #1029TREATMENTS/TRIALSPAGE: 1DEPARTMENT: FACILITYWIDE OF: 1EFFECTIVE: APPROVED BY: REVISED: ... |
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