Examples of OSI in a sentence
Please see the OSI Pre-NDA/BLA Request document for a full description of requested data filesReferences: eCTD Backbone Specification for Study Tagging Files v.
The Member must withdraw from the meeting at the commencement of the consideration of any matter in which they have declared a OSI and must not participate in any discussion of, or vote taken on, the matter unless they have been granted a dispensation to do so or the meeting is one at which members of the public are permitted to speak for the purpose of making representations, answering questions or giving evidence relating to the matter.
Electronic submission of the site level dataset is voluntary and is intended to facilitate the timely selection of appropriate clinical sites for FDA inspection as part of the application and/or supplement review process.This request also provides instructions for where OSI requested items should be placed within an eCTD submission (Attachment 1, Technical Instructions: Submitting Bioresearch Monitoring (BIMO) Clinical Data in eCTD Format).
If during the consideration of any item a Member becomes aware that they have a DPI in the matter they should declare the interest immediately and, subject to any dispensations, withdraw from the meeting.Other Significant Interest (OSI)Where a Member is declaring an OSI they must also disclose the interest and explain the nature of the interest at the meeting.
A member who declares an OSI in relation to any item will need to remove him/herself to the public gallery before the debate and not vote on that item (unless a relevant dispensation has been granted).