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FAQ - German SAE Report Form

FAQ - German SAE Report Form 2025

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The document is a Medical Device Adverse Event Reporting Form (MDAR1) for manufacturers, importers, suppliers, or registrants of medical devices in Singapore. It outlines the mandatory reporting requirements for adverse events related to medical devices as per the Health Products Act and regulations. The form includes sections for general information, device details, event description, investigation results, patient information, and healthcare facility information. It emphasizes the importance of accurate reporting and provides guidance on filling out the form.

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2023	4.2 Satisfied (52 Votes)
2017	4.2 Satisfied (45 Votes)

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How long do you have to report an adverse event?

SAE end/stop date: SAE end date is the date of AE recovery. What is NOT an SAE? Hospital admissions planned for: ❖ Any intervention or surgery planned before study entry or for social reasons, ❖ Any elective surgery (i.e. plastic surgery).

How do I report SAE in clinical trials?

SAE should be reported to the sponsor within 24 hours of the investigator site team knowledge of the event whether verbally or in writing. A full report is to follow with the details and outcome of the event. It should also be recorded and documented as the case with AE.

What is the difference between AE and SAE reporting?

A serious adverse event (SAE) is any AE that:  results in death;  is life threatening (i.e. the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe);  requires hospitalisation or prolongation of existing

What makes an SAE reportable?

Any adverse experience associated with the use of the drug that is both serious and unexpected and. Any finding from tests in laboratory animals that suggests a significant risk for human subjects (21 CFR 312.32(c)(1)(i)(A),(B))

When should investigator report SAE to sponsor?

An investigator (if he/she is not a sponsor-investigator) must report to the sponsor any serious adverse event within 24 hours of investigator learning about the event, whether or not considered drug related, including those listed in the protocol or investigator brochure and must include an assessment of whether there

How long do you have to report an SAE?

For serious and unexpected, but non-fatal adverse events, file as soon as possible and no later than 15 days after initial receipt of the SAE. All SAEs must be reported to the IRB within 5 business days as reportable new information.

FAQ - German SAE Report Form 2025

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