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Who is responsible for SAE reporting?

The trial sponsor is responsible for ongoing safety evaluation of an investigational product (IP) and reporting and compensating the participant in case of any serious adverse event (SAE).

Which is the initial step of SAE reporting?

Within 24 Hours of SAE occurrence PI ➢ Sponsor ➢ CMC Ethics committee ➢ DCGI ➢ This is an initial report ➢ If PI does not report within the time frame, a letter of explanation has to be sent to the CMC Ethics Committee. GUIDELINES FOR REPORTING SERIOUS ADVERSE EVENTS cmch-vellore.edu sites research Files cmch-vellore.edu sites research Files

What is an example of a Serious Adverse Event?

Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. What is a Serious Adverse Event? - FDA Food and Drug Administration (.gov) reporting-serious-problems-fda Food and Drug Administration (.gov) reporting-serious-problems-fda

How do I write a SAE report?

How to write an serious adverse event narrative? Patient details. Study details. Patient history (medical history, concomitant diseases, family history, and concomitant drugs) Details of the study drug. Event description and treatment details. Laboratory tests information. Action taken with the study drug. Outcome of event/s.

When should an adverse event be reported?

Report if the adverse event resulted in a substantial disruption of a persons ability to conduct normal life functions, i.e., the adverse event resulted in a docHub, persistent or permanent change, impairment, damage or disruption in the patients body function/structure, physical activities and/or quality of

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What is the timeline for an investigator to report a SAE to the sponsor?

An SAE report should be submitted to the Sponsor no later than 24 hours after the site becomes aware of the event. As the site gains more information (i.e. admission records, hospital discharge summaries) updated SAE reports with the new information should be submitted to the Sponsor.

What is an SAE report?

Serious Adverse Event (SAE): Any adverse event that: Results in death. Is life threatening, or places the participant at immediate risk of death from the. event as it occurred. NIA Adverse Event and Serious Adverse Event Guidelines nih.gov nia-ae-and-sae-guidelines-2018 nih.gov nia-ae-and-sae-guidelines-2018

What are the 4 criteria for adverse event reporting?

The minimum dataset required to consider information as a reportable AE is indeed minimal, namely (1) an identifiable patient, (2) an identifiable reporter, (3) product exposure, and (4) an event. Adverse Event Detection, Processing, and Reporting - NCBI nih.gov books NBK208615 nih.gov books NBK208615

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