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Study Tagging Files (STFs) offer clarity to an eCTD reviewer sifting through a submission's clinical data by organizing it in a standardized, meaningful manner.
 These are validation criteria that it is considered good practice to ensure are correct The level of adherance to these names is specified in the eCTD or NeeS
 18 Apr 2017 Scanned documents are more difficult to read and often the quality is lower. Further CDISC Data Standards: Understanding the Guidance for
 Common Technical Document ICH eCTD Specification V 3.0 October 08 2002. Page 2 .. Folder and File Naming Conventions. Examples for meta-data on document level are versioning information, language, descriptive information.
 25 Mar 2010 Best authoring practices for eCTD documents eCTD (electronic common technical document) developed Use meaningful file names.
 eCTD templates. Off-the-shelf authoring templates. Document management system. Author training. eCTD outsourcing. Regulatory compliance. eCTD
 Best practices for eCTD authoring and publishing; Challenges for CMC specialists. 2 Multiple files, usually PDF; Granularity as per ICH M4 annex (as for the paper CTD) e.g. substance, product-name, dosageform, manufacturer etc.
 Inclusion of non-eCTD correspondence documentation . It is at the discretion of the applicant to comment best practice criteria on the form technical
 2 Sep 2013 Moving to eCTD Format from Paper or NeeS Type Applications . organisation of an eCTD submission is defined by the following standards: . For further guidance on file naming, please refer to the “File-Folder Structure
 9 Apr 2013 eCTD is now a mature standard with a body of best practices based on This is best accomplished by using auto-naming for documents in the
     
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