WebPeriodicity and DSUR data lock point* .....6 2.3. Duration of DSUR submissions.....7 2.4. Responsibilities for preparing and ... The main focus of the DSUR is data and findings from interventional clinical trials* (hereafter referred to as “clinical trials”) of drugs and … 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 …

Data Lock Point Definition Law Insider

WebThe dates of a DSUR and PSUR submission can be synchronised by preparing a DSUR based on the PSUR international birthday (IBD). Then the data lock point of the DSUR, … Webdays after the DSUR data lock point. 5.3 Preparation of the DSUR and co-ordinated responsibilities 5.3.1 The Sponsor of a clinical trial is considered responsible for the preparation, content and submission of a DSUR. The Sponsor can delegate the preparation of the DSUR to a third party (e.g. a contract research organisation). immature common tern

Data Lock Definition Law Insider

Web• One DSUR for one investigational drug, due within 60 days after the date of first Clinical Trial Application “ok to proceed” in any region, and not longer than 60 days after the data lock point • Single data lock point: last day of the 1 year reporting period, or last day of month prior to Day 1 of birth date month WebOverview of new DSUR ICH Guidance – Key points DIBD Development International Birth Date The sponsor’s first authorization to conduct a clinical trial in any country worldwide. … WebData Lock means, in respect of a clinical trial in support of a new drug application, the time at which, in accordance with the trial protocol, no modifications will be made to the … immature coworkers