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SECTION IX
INVESTIGATIONAL DRUGSWHITING FORENSIC HOSPITAL
PHARMACY POLICY AND PROCEDURE MANUALSECTION IX:
CHAPTER 9.1:INVESTIGATIONAL DRUGS
USE OF INVESTIGATIONAL DRUGSPOLICY:Initiation of new investigational
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01
To fill out the use of investigational drugs, follow these steps:
02
Begin by obtaining the necessary consent forms and patient information.
03
Ensure that you have a thorough understanding of the investigational drug's purpose, dosage, and administration instructions.
04
Prepare the necessary equipment and supplies.
05
Follow all safety protocols and guidelines while handling the investigational drug.
06
Administer the drug to the patient as directed, ensuring proper dosage and administration technique.
07
Monitor the patient closely for any adverse reactions or side effects.
08
Keep detailed records of the drug administration, including dates, dosage, and any observed effects.
09
Report any changes or concerns to the relevant medical authority or research team.
10
Follow up with the patient as necessary to evaluate the drug's effectiveness and monitor for any long-term effects.
11
Continuously update and maintain accurate documentation throughout the process.
12
Remember to always follow ethical and legal guidelines when using investigational drugs.
Who needs use of investigational drugs?
01
The use of investigational drugs may be necessary for individuals who meet specific criteria, such as:
02
- Patients with life-threatening illnesses or conditions for which there are no approved treatment options.
03
- Patients who have exhausted all available approved treatments and are willing to explore alternative options.
04
- Patients who are participating in clinical trials or research studies that involve investigational drugs.
05
- Patients who have provided informed consent and understand the potential benefits and risks associated with using investigational drugs.
06
Ultimately, the decision to use investigational drugs should be made in collaboration between the patient, healthcare provider, and relevant research team.
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What is use of investigational drugs?
Investigational drugs are used in clinical trials to test the safety and effectiveness of new medications before they are approved for general use.
Who is required to file use of investigational drugs?
Any entity or individual conducting a clinical trial using investigational drugs is required to file with the appropriate regulatory authorities.
How to fill out use of investigational drugs?
The use of investigational drugs must be filled out by providing detailed information about the drug, the study protocol, the participants, and any adverse events.
What is the purpose of use of investigational drugs?
The purpose of the use of investigational drugs is to ensure the safety and well-being of participants in clinical trials, as well as to gather data on the effectiveness of the drug.
What information must be reported on use of investigational drugs?
Information that must be reported includes the name of the investigational drug, the dosage, the administration route, the study protocol, and any adverse events.
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