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REVIEW GUIDANCE FOR Suicide/Clinical and Adverse Event Management Adult Mental Health, Child & Adolescent Mental Health Service, Community Alcohol & Drug Service, Learning Disability, Older Adult
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What is suicideclinical and adverse event?
Suicideclinical and adverse event refers to incidents where a patient exhibits suicidal behavior or experiences adverse effects while participating in a clinical trial or using medical products.
Who is required to file suicideclinical and adverse event?
The sponsors or investigators of the clinical trial are required to file suicideclinical and adverse event reports.
How to fill out suicideclinical and adverse event?
The reports should be filled out according to the specific guidelines provided by regulatory authorities, detailing the patient's information, event description, and any related factors.
What is the purpose of suicideclinical and adverse event?
The purpose is to ensure the safety of patients in clinical trials and to collect data on any potential risks or safety concerns associated with medical products.
What information must be reported on suicideclinical and adverse event?
The reports must include detailed information about the patient, the event, any potential contributing factors, and the outcome.
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