WebNov 25, 2024 · The data lock point of the DSUR should be the last day of the one-year reporting period. For administrative convenience, if desired by the sponsor, the data lock point of the DSUR can be designated as the last day of the month prior to the month of the DIBD. The DSUR should be submitted to all concerned regulatory authorities no later … WebThis document proposes a common standard for periodic reporting on drugs under development among the ICH regions - the development safety update report (DSUR). It …

Difference between DSUR, IND Annual Report, and ASR

WebThe main focus of the DSUR is data and findings from interventional clinical trials* (hereafter referred to as “clinical trials”) of drugs and biologicals that are under ... 2.2 Periodicity … WebNov 1, 2014 · Periodicity and DSUR Data Lock Point DSUR should be submitted no later than 60 calendar days from DSUR data lock point Development International Birth Date (DIBD): Date of the sponsors first authorization to conduct a clinical trial in any country For administrative convenience, DIBD is the last day of MOA real chef

27. Development safety update report (DSUR)

WebData Lock Point (DLP) Effective Date of IND EU DIBD→ IBD Recipients FDA Member State Competent Authority(ies), Independent Ethics ... Si l DSURSingle DSUR A single … WebAug 21, 2013 · The DSUR is the pre-marketing equivalent of the post-marketing Periodic Safety Update Report (PSUR). It covers drugs, biological, vaccines and combo products. It is a stand-alone document that is not just a data dump but is an analytical document. It should be “clear and succinct” (as all documents should be but rarely are). WebA DSUR should be submitted until the last visit of the last patient in the last study in the country(ies) concerned. The DSUR should be submitted no later than 60 calendar days from the DSUR data lock point (DLP). A few … real chemistry llc