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Administrative
Policies and ProceduresOriginating Venue: Ethics, Rights and Responsibilities
Title: Investigational Drugs
Date Issued: 05/09
Date Reviewed: 06/11
Date: Revised: 07/14
Attachment: NonePolicy
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What is title investigational drugs?
Title investigational drugs refer to drugs that are currently being tested in clinical trials for safety and effectiveness.
Who is required to file title investigational drugs?
The sponsor or investigator conducting the clinical trial is required to file title investigational drugs.
How to fill out title investigational drugs?
Title investigational drugs can be filled out electronically through the designated regulatory authority's online portal.
What is the purpose of title investigational drugs?
The purpose of title investigational drugs is to track the use of investigational drugs in clinical trials and ensure proper reporting.
What information must be reported on title investigational drugs?
Information such as the drug name, trial phase, study location, and sponsor details must be reported on title investigational drugs.
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