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All Adverse Events must be reported within 24 hours after onset. Please email the AE to pcstudy@amc.nl A follow up report must be sent within 7 days and final report when outcome of AE is known.Local
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How to fill out non-local serious adverse event

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How to fill out non-local serious adverse event

01
Gather all necessary information related to the event, including patient details, symptoms, and any treatments given.
02
Fill out the appropriate forms provided by the regulatory authorities or the institution where the event occurred.
03
Ensure that all information is accurately documented and supported by relevant documentation such as medical records or lab reports.
04
Submit the completed form to the appropriate authorities within the specified timeline.

Who needs non-local serious adverse event?

01
Healthcare professionals and institutions involved in clinical trials or patient care need to fill out non-local serious adverse event reports.

What is non-local serious adverse event report Form?

The non-local serious adverse event report is a document that should be submitted to the required address to provide certain info. It needs to be filled-out and signed, which may be done manually in hard copy, or with the help of a particular solution e. g. PDFfiller. This tool allows to fill out any PDF or Word document right in the web, customize it according to your purposes and put a legally-binding e-signature. Once after completion, the user can easily send the non-local serious adverse event report to the appropriate recipient, or multiple individuals via email or fax. The blank is printable as well thanks to PDFfiller feature and options offered for printing out adjustment. Both in electronic and physical appearance, your form should have a organized and professional appearance. It's also possible to turn it into a template to use later, so you don't need to create a new document from the beginning. All that needed is to customize the ready template.

Instructions for the non-local serious adverse event report form

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A non-local serious adverse event refers to any significant negative health effect experienced by a participant in a clinical trial or study that occurs outside the local study site, and that requires medical intervention or results in significant harm or death.
The sponsor of the clinical study or the principal investigator at the study site is required to file a non-local serious adverse event.
To fill out a non-local serious adverse event, one must provide detailed information including the patient's demographics, a description of the event, the date it occurred, any interventions required, and any outcomes related to the event.
The purpose of reporting non-local serious adverse events is to ensure patient safety, facilitate regulatory oversight, and contribute to the knowledge regarding the risks associated with the clinical study or intervention.
The information that must be reported includes the identifier of the event, patient demographics, details of the adverse event, the treatment context, outcomes of the event, and any actions taken in response to the event.
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