SDTM aCRF Guideline v1.0 SDTM aCRF Guideline - Guideline for SDTM annotations in Case Report Forms Summary and Recommendations for Best Practice © 2020 by Authors, Published under Creative Commons License (CC BY-NC-ND) 4.0 Version V1.0 Date 2020-11-20 Authors Task Lead: Markus Stoll Co-Lead Stefanie Sturm (mainanalytics GmbH) Co-Authors: Christina Paul Eva Bervar (Bayer AG) Michael Schmitz (Bayer AG) Petra Rein Stefan Bordasch (AbbVie Deutschland GmbH & Co. KG) Torsten Petsching (Boehringer Ingelheim Pharma GmbH & Co. KG) 2020-11-20 Page 1 of 46 SDTM aCRF Guideline v1.0 Table of Content 1. Introduction .................................................................................................................................................................................................................................... 5 Background ......................................................................................................................................................................................................................................... 5 Purpose ............................................................................................................................................................................................................................................... 5 Disclaimer ........................................................................................................................................................................................................................................... 6 Identified Main Sources ...................................................................................................................................................................................................................... 7 2. Prerequisites / Requirements ......................................................................................................................................................................................................... 8 FDA eCTD Portable Document Format (PDF) Specifications (v4.1, 21 Sep. 2016) ............................................................................................................................. 8 PURPOSE ......................................................................................................................................................................................................................................... 8 VERSION .......................................................................................................................................................................................................................................... 8 SECURITY ........................................................................................................................................................................................................................................ 9 FONTS ........................................................................................................................................................................................................................................... 10 PAGE ORIENTATION...................................................................................................................................................................................................................... 11 PAGE SIZE AND MARGINS ............................................................................................................................................................................................................. 11 SOURCE OF ELECTRONIC DOCUMENTS ........................................................................................................................................................................................ 12 METHODS FOR CREATING PDF DOCUMENTS AND IMAGES ......................................................................................................................................................... 12 IMAGE COMPRESSION TO REDUCE FILE SIZE ............................................................................................................................................................................... 13 OPTIMIZE FOR FAST WEB VIEW AND OPENING SETTINGS ........................................................................................................................................................... 13 IMAGE COLOR MATCHING ........................................................................................................................................................................................................... 17 USE OF THUMBNAILS ................................................................................................................................................................................................................... 17 DOCUMENT NAVIGATION ............................................................................................................................................................................................................ 17 INITIAL VIEW SETTINGS ................................................................................................................................................................................................................ 18 PAGE NUMBERING ....................................................................................................................................................................................................................... 18 NAMING PDF FILES ....................................................................................................................................................................................................................... 18 SPECIAL CONSIDERATIONS FOR PROMOTIONAL LABELING AND ADVERTISING MATERIAL ........................................................................................................ 18 FDA, “Study Data Specifications” (V2.0, July 18, 2012) .................................................................................................................................................................... 19 5.4 Annotated case report form ................................................................................................................................................................................................... 19 2020-11-20 Page 2 of 46 SDTM aCRF Guideline v1.0 FDA, "Study Data Technical Conformance Guide" (v4.4, Oct 2019) ................................................................................................................................................. 19 4.1.4.6 Annotated Case Report Form (aCRF) for SDTM ............................................................................................................................................................... 19 8.3.2.1 Traceability Issues with Legacy Data Conversion (Tech Conformance Guide) ................................................................................................................. 20 8.3.2.2 Legacy Data Conversion Plan and Report (Technical Conformance Guide) ..................................................................................................................... 22 Other Recommendations and Best Practice .................................................................................................................................................................................... 22 Pre-requisites for the underlying document(s) of the annotated CRF ......................................................................................................................................... 22 3. Format .......................................................................................................................................................................................................................................... 23 File Format and Naming Conventions .............................................................................................................................................................................................. 23 Page Numbering ............................................................................................................................................................................................................................... 23 Annotations ...................................................................................................................................................................................................................................... 23 Annotated Comment/Instruction Boxes .......................................................................................................................................................................................... 23 4. Bookmarks .................................................................................................................................................................................................................................... 24 5. Table of Content (TOC) ................................................................................................................................................................................................................. 25 6. Annotations .................................................................................................................................................................................................................................