The reporting time frame for Serious Adverse Events (SAEs) to the local Institutional Review Board (IRB) can vary depending on the regulations and guidelines set by the specific IRB and the governing authorities overseeing the research.
In general, researchers are required to report SAEs to the IRB promptly, typically within a specific timeline defined by the IRB's policies. The exact reporting time frame is often specified in the study protocol approved by the IRB. It is crucial for researchers to follow the reporting requirements diligently to ensure the safety and well-being of research participants and to comply with ethical standards and regulatory obligations.
To get the accurate and specific reporting time frame for SAEs, researchers should refer to the study protocol approved by the IRB, the informed consent documents, and any applicable regulatory guidelines or local laws governing the research. It is also essential for researchers to communicate with the IRB and the sponsor of the study in case of any uncertainties or questions related to reporting SAEs.