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CLINICAL TRIAL SITE NOTIFICATION
This form only needs to be completed (by the site manager or a person in charge of the site),
for a clinical trial site at which trial participants are required to
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What is clinical trial site notification?
Clinical trial site notification is a mandatory process where sponsors or investigators inform regulatory authorities about the sites where a clinical trial will be conducted.
Who is required to file clinical trial site notification?
Sponsors or investigators conducting a clinical trial are required to file clinical trial site notification.
How to fill out clinical trial site notification?
Clinical trial site notification is typically filled out online through the regulatory authority's portal, following the specific guidelines provided.
What is the purpose of clinical trial site notification?
The purpose of clinical trial site notification is to ensure transparency, oversight, and compliance with regulations regarding the conduct of clinical trials at specific sites.
What information must be reported on clinical trial site notification?
Information such as site contact details, ethics committee approval, regulatory approvals, qualifications of investigators, and facilities available at the site must be reported on clinical trial site notification.
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